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Clinical Trial Results:
Effect of drop-less surgery compared to topical NSAID alone and combination of steroid and NSAID on central macular thickness after cataract surgery, a randomized controlled trial

Summary
EudraCT number	2017-002666-47
Trial protocol	DK
Global end of trial date	18 Dec 2019

Results information
Results version number	v1(current)
This version publication date	31 Dec 2020
First version publication date	31 Dec 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

SOAP1

ISRCTN number

US NCT number

NCT03383328

WHO universal trial number (UTN)

Sponsor organisation name

Dpt. of Ophthalmology, Rigshospitalet-Glostrup

Sponsor organisation address

Valdemar Hansens Vej 1-23, Glostrup, Denmark, 2600

Public contact

Dpt. of Ophthalmology, Ø37, Dpt. of Ophthalmology, Rigshospitalet-Glostrup, 0045 38634770,

Scientific contact

Dpt. of Ophthalmology, Ø37, Dpt. of Ophthalmology, Rigshospitalet-Glostrup, 0045 38634770,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 Jun 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

18 Dec 2019

Global end of trial reached?

Yes

Global end of trial date

18 Dec 2019

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively.

Protection of trial subjects

To detect complications and quickly initiate treatment participants were closely monitored throughout the study period. At the postoperative visits patients were checked for adverse effects to the anti-inflammatory prophylaxis. The postoperative visits included measuring of best corrected visual acuity and intraocular pressure (IOP) and evaluation of the eye by slit-lamp imaging. The patients were alsoasked for subjective complaints and symptoms related to the treatment. Postoperative visits were scheduled to detect adverse effects when they were expected to present. I.e. the 3rd-day review would detect excessive postoperative inflammation, early elevations in IOP, complications to application of the steroid depot and complications to surgery that were not detected immediately after surgery. The 3-week review would detect elevated IOP and potential infections or corneal defects following prophylactic treatment. The main purpose of the 3-month review was to detect increased central macular thickness which develops within the first 3 months following surgery. Patients were instructed to contact the investigators immediately if vision got worse, the eye turned red and/or painful or they became sensitive to light, experienced a curtain-like shadow over the visual field, experienced flashes of light or halos around light sources.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Feb 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Denmark: 470

Worldwide total number of subjects

470

EEA total number of subjects

470

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

389

85 years and over

Subject disposition

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Recruitment details

All participants were recruitet from February 1 2018 to August 15 2019 at Department of Ophthalmology, Rigshospitalet-Glostrup, Denmark.

Screening details

We screened 868 patients who were referred for a preoperative evaluation for cataract surgery at Department of Ophthalmology, Rigshospitalet-Denmark. Of those, 398 were not included; 211 did not want to participate and 187 did not meet criteria for inclusion.

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Data analyst ^[1]

Blinding implementation details

Groups were renamed by an independent researcher prior to data analyses.

Are arms mutually exclusive

Yes

Pred+NSAID-Pre

Arm description

Combination of prednisolone- and ketorolac eye drops three times per day until three weeks after surgery with initiation three days before surgery

Arm type

Active comparator

Investigational medicinal product name

Pred Forte 1%

Investigational medicinal product code

S01BA04

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Ocular use

Dosage and administration details

One drop applied to the ocular surface three times per day from three days before cataract surgery until three weeks after cataract surgery.

Investigational medicinal product name

Acular 0.5%

Investigational medicinal product code

S 01 BC 05

Other name

Pharmaceutical forms

Eye drops, suspension

Routes of administration

Ocular use

Dosage and administration details

One drop applied to the ocular surface three times per day from three days before cataract surgery until three weeks after cataract surgery.

Pred+NSAID-Post

Arm description

Combination of prednisolone- and ketorolac eye drops three times per day until three weeks after surgery with initiation on the day of surgery

Arm type

Experimental

Investigational medicinal product name

Pred Forte 1%

Investigational medicinal product code

S01BA04

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Ocular use

Dosage and administration details

One drop applied to the ocular surface three times per day from the day of cataract surgery until three weeks after cataract surgery.

Investigational medicinal product name

Acular 0.5%

Investigational medicinal product code

S 01 BC 05

Other name

Pharmaceutical forms

Eye drops, suspension

Routes of administration

Ocular use

Dosage and administration details

One drop applied to the ocular surface three times per day from the day of cataract surgery until three weeks after cataract surgery.

NSAID-Pre

Arm description

Monotherapy with ketorolac eye drops three times per day until three weeks after surgery with initiation three days before surgery

Arm type

Experimental

Investigational medicinal product name

Acular 0.5%

Investigational medicinal product code

S 01 BC 05

Other name

Pharmaceutical forms

Eye drops, suspension

Routes of administration

Ocular use

Dosage and administration details

One drop applied to the ocular surface three times per day from three days before cataract surgery until three weeks after cataract surgery.

NSAID-Post

Arm description

Monotherapy with ketorolac eye drops three times per day until three weeks after surgery with initiation on the day of surgery

Arm type

Experimental

Investigational medicinal product name

Acular 0.5%

Investigational medicinal product code

S 01 BC 05

Other name

Pharmaceutical forms

Eye drops, suspension

Routes of administration

Ocular use

Dosage and administration details

One drop applied to the ocular surface three times per day from the day of cataract surgery until three weeks after cataract surgery.

Drop-less

Arm description

Subtenon depot of 0.5 mL dexamethasone phosphate administered at the conclusion of cataract surgery

Arm type

Experimental

Investigational medicinal product name

Dexamethason Krka phosphate 4 mg/ml solution for injection/infusion

Investigational medicinal product code

H02AB02

Other name

Dexavital

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Ocular use

Dosage and administration details

Subtenon depot of 0.5 mL dexamethasone phosphate (4 mg/ML) administered at the conclusion of cataract surgery.

Notes
[1] - The roles blinded appear inconsistent with a simple blinded trial.
Justification: Due to the study design with one group not receiving eye drops, participants and outcome assessors could not be blinded to allocation status. Blinding was achieved by performing data analyses without knowledge of allocation status. This was done by renaming the interventional groups prior to analyzing. Renaming was carried out by a researcher with no relation to the study.

Number of subjects in period 1	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Started	94	94	94	94	94
Completed	85	92	83	88	81
Not completed	9	2	11	6	13
Consent withdrawn by subject	3	1	2	2	6
Completed last follow-up visit outside timeframe	-	1	3	-	1
Lost to follow-up	3	-	2	2	1
Criteria for exclusion met after allocation	3	-	4	2	5

Baseline characteristics

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Reporting group title

Overall trial

Reporting group description

Reporting group values	Overall trial	Total
Number of subjects	470	470
Age categorical
Units: Subjects
In utero		0
Preterm newborn infants (gestational age < 37 wks)		0
Newborns (0-27 days)		0
Infants and toddlers (28 days-23 months)		0
Children (2-11 years)		0
Adolescents (12-17 years)		0
Adults (18-64 years)		0
From 65-84 years		0
85 years and over		0
Age continuous
Age at inclusion
Units: years
arithmetic mean (standard deviation)	72.1 ± 7.0	-
Gender categorical
Units: Subjects
Female	290	290
Male	180	180
Grading of Nuclear Cataract
Severity of cataract was determined according to the Age-Related Eye Disease Study (AREDS) system for classification of cataracts
Units: Subjects
Nuclear Cataract < 1	2	2
Nuclear Cataract = 1	13	13
Nuclear Cataract = 1.5	95	95
Nuclear Cataract = 2.0	160	160
Nuclear Cataract = 2.5	124	124
Nuclear Cataract = 3	72	72
Nuclear Cataract > 3	4	4
Not Recorded	0	0
Cortical Cataract grade
Severity of cataract was determined according to the Age-Related Eye Disease Study (AREDS) system for classification of cataracts
Units: Subjects
Cortical Cataract < 1	230	230
Cortical Cataract = 1	86	86
Cortical Cataract = 1.5	51	51
Cortical Cataract = 2	70	70
Cortical Cataract = 2.5	19	19
Cortical Cataract = 3	12	12
Cortical Cataract > 3	2	2
Not recorded	0	0
Posterior Subcapsular Cataract grade
Severity of cataract was determined according to the Age-Related Eye Disease Study (AREDS) system for classification of cataracts
Units: Subjects
PSC < 1	326	326
PSC = 1	52	52
PSC = 1.5	26	26
PSC = 2	25	25
PSC = 2.5	17	17
PSC = 3	17	17
PSC > 3	7	7
Not recorded	0	0
Laterality (eye)
Number of left and right eyes included
Units: Subjects
Right eye	246	246
Left eye	224	224
Central Macular Thickness
Measured by optical coherence tomography (OCT, DRI OCT Triton, Topcon Europe Medical BV) using the central 1.0 mm zone of ETDRS (Early Treatment Diabetic Retinopathy Study) grid obtained from the in-build software (IMAGEnet 6, Topcon Europe Medical BV)
Units: micrometers
arithmetic mean (standard deviation)	243.2 ± 21.8	-
Corrected Distance Visual Acuity
Measured using an ETDRS chart
Units: logMAR
arithmetic mean (standard deviation)	0.29 ± 0.15	-
Intraocular Pressure
Measured using a rebound tonometer (iCare Finland) and controlled by Goldman applanation tonometry intraocular pressure > 25 mm Hg
Units: mm Hg
arithmetic mean (standard deviation)	14.3 ± 3.9	-
Anterior Chamber Flare
Anterior chamber flare was measured on undilated pupils by flare photometer (KOWA FM-600, KOWA Company) using an average of five reliable measurements.
Units: photons per millisecond
median (inter-quartile range (Q1-Q3))	9.7 (7.3 to 13.2)	-
Average Retinal Nerve Fiber Layer Thickness
Retinal Nerve Fiber Layer thickness was measured by peripapillary optical coherence tomography (OCT, DRI OCT Triton, Topcon Europe Medical BV) and obtained from the in-build software (IMAGEnet 6, Topcon Europe Medical BV)
Units: micrometers
arithmetic mean (standard deviation)	95.6 ± 12.5	-

End points

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Reporting group title

Pred+NSAID-Pre

Reporting group description

Combination of prednisolone- and ketorolac eye drops three times per day until three weeks after surgery with initiation three days before surgery

Reporting group title

Pred+NSAID-Post

Reporting group description

Combination of prednisolone- and ketorolac eye drops three times per day until three weeks after surgery with initiation on the day of surgery

Reporting group title

NSAID-Pre

Reporting group description

Monotherapy with ketorolac eye drops three times per day until three weeks after surgery with initiation three days before surgery

Reporting group title

NSAID-Post

Reporting group description

Monotherapy with ketorolac eye drops three times per day until three weeks after surgery with initiation on the day of surgery

Reporting group title

Drop-less

Reporting group description

Subtenon depot of 0.5 mL dexamethasone phosphate administered at the conclusion of cataract surgery

Primary: Central Macular Thickness 3 months postoperative

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End point title

Central Macular Thickness 3 months postoperative

End point description

Primary outcome was central macular thickness (CMT) at the three-month visit measured by optical coherence tomography (OCT, DRI OCT Triton, Topcon Europe Medical BV) using the central 1.0 mm zone of ETDRS (Early Treatment Diabetic Retinopathy Study) grid obtained from the in-build software (IMAGEnet 6, Topcon Europe Medical BV)

End point type

Primary

End point timeframe

Three months after cataract surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91 ^[1]	94	90 ^[2]	92 ^[3]	89 ^[4]
Units: micrometers
arithmetic mean (confidence interval 95%)	250.7 (247.6 to 253.7)	250.7 (247.8 to 253.7)	251.3 (248.2 to 254.4)	249.2 (246.2 to 252.3)	255.2 (252.0 to 258.3)

Notes
[1] - 3 participants met criteria for exclusion after allocation.
[2] - 4 participants met criteria for exclusion after allocation.
[3] - 2 participants met criteria for exclusion after allocation.
[4] - 5 participants met criteria for exclusion after allocation.

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. Significance level was adjusted for multiple testing using Bonferroni correction resulting in a significance level = 0.0125. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

185

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.97

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.1

Confidence interval

level

98.75%

sides

2-sided

lower limit

-5.4

upper limit

5.5

Variability estimate

Standard error of the mean

Dispersion value

2.2

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.79

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.6

Confidence interval

level

98.75%

sides

2-sided

lower limit

-5

upper limit

6.2

Variability estimate

Standard error of the mean

Dispersion value

2.2

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.51

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.5

Confidence interval

level

98.75%

sides

2-sided

lower limit

-7

upper limit

4.1

Variability estimate

Standard error of the mean

Dispersion value

2.2

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

180

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.04

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

4.5

Confidence interval

level

98.75%

sides

2-sided

lower limit

-1.1

upper limit

10.1

Variability estimate

Standard error of the mean

Dispersion value

2.2

Secondary: Central macular thickness 3 weeks postoperative

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End point title

Central macular thickness 3 weeks postoperative

End point description

Central macular thickness (CMT) at the three-month visit measured by optical coherence tomography (OCT, DRI OCT Triton, Topcon Europe Medical BV) using the central 1.0 mm zone of ETDRS (Early Treatment Diabetic Retinopathy Study) grid obtained from the in-build software (IMAGEnet 6, Topcon Europe Medical BV)

End point type

Secondary

End point timeframe

Three weeks after cataract surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	94	90	92	89
Units: micrometers
arithmetic mean (confidence interval 95%)	248.4 (244.8 to 252.1)	251.5 (247.9 to 255.0)	252.2 (248.6 to 255.9)	249.6 (246.1 to 253.2)	259.7 (255.9 to 263.4)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

185

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.48

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

8.1

Variability estimate

Standard error of the mean

Dispersion value

2.6

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.32

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

3.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

8.9

Variability estimate

Standard error of the mean

Dispersion value

2.6

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.91

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-3.9

upper limit

6.3

Variability estimate

Standard error of the mean

Dispersion value

2.6

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

180

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

11.2

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

16.4

Variability estimate

Standard error of the mean

Dispersion value

2.6

Secondary: Anterior Chamber Flare at 3 days postoperative

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End point title

Anterior Chamber Flare at 3 days postoperative

End point description

Anterior chamber flare was measured on undilated pupils by flare photometer (KOWA FM-600, KOWA Company) using an average of five reliable measurements.

End point type

Secondary

End point timeframe

Three days after cataract surgery.

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	94	90	92	89
Units: photons per milisecond
median (confidence interval 95%)	17.6 (15.7 to 19.7)	18.1 (16.1 to 20.2)	20.6 (18.3 to 23.1)	19.6 (17.5 to 22.0)	30.4 (27.0 to 34.2)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. This analysis was considered a primary analysis regarding the early postoperative inflammatory respons and significance level was adjusted for multiple testing using Bonferroni correction resulting in a significance level = 0.0125.

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

185

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

P-value

= 0.73

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.04

Confidence interval

level

98.75%

sides

2-sided

lower limit

-0.25

upper limit

0.33

Variability estimate

Standard error of the mean

Dispersion value

0.12

Notes
[5] - Flare-values were log2-transformed for statistical analyses. Results presented beneath are on log2-scale.

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. This analysis was considered a primary analysis regarding the early postoperative inflammatory respons and significance level was adjusted for multiple testing using Bonferroni correction resulting in a significance level = 0.0125.

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority ^[6]

P-value

= 0.05

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.22

Confidence interval

level

98.75%

sides

2-sided

lower limit

-0.06

upper limit

0.52

Variability estimate

Standard error of the mean

Dispersion value

0.12

Notes
[6] - Flare-values were log2-transformed for statistical analyses. Results presented beneath are on log2-scale.

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. This analysis was considered a primary analysis regarding the early postoperative inflammatory respons and significance level was adjusted for multiple testing using Bonferroni correction resulting in a significance level = 0.0125.

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority ^[7]

P-value

= 0.17

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.16

Confidence interval

level

98.75%

sides

2-sided

lower limit

-0.13

upper limit

0.45

Variability estimate

Standard error of the mean

Dispersion value

0.12

Notes
[7] - Flare-values were log2-transformed for statistical analyses. Results presented beneath are on log2-scale.

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. This analysis was considered a primary analysis regarding the early postoperative inflammatory respons and significance level was adjusted for multiple testing using Bonferroni correction resulting in a significance level = 0.0125.

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

180

Analysis specification

Pre-specified

Analysis type

superiority ^[8]

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.79

Confidence interval

level

98.75%

sides

2-sided

lower limit

0.5

upper limit

1.09

Variability estimate

Standard error of the mean

Dispersion value

0.12

Notes
[8] - Flare-values were log2-transformed for statistical analyses. Results presented beneath are on log2-scale.

Secondary: Intraocular Pressure - 3 days postoperative

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End point title

Intraocular Pressure - 3 days postoperative

End point description

Intraocular pressure measured 3 days after surgery using a rebound tonometer (Icare, Finland)

End point type

Secondary

End point timeframe

Three days after surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	94	90	92	88
Units: mm Hg
arithmetic mean (confidence interval 95%)	13.6 (12.9 to 14.2)	13.4 (12.8 to 14.0)	11.5 (10.9 to 12.1)	11.0 (10.4 to 11.6)	10.3 (9.7 to 11.0)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

185

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.92

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

0.7

Variability estimate

Standard error of the mean

Dispersion value

0.43

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-2.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2.9

upper limit

-1.2

Variability estimate

Standard error of the mean

Dispersion value

0.43

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-3.4

upper limit

-1.7

Variability estimate

Standard error of the mean

Dispersion value

0.43

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-3.2

Confidence interval

level

95%

sides

2-sided

lower limit

-4.1

upper limit

-2.4

Variability estimate

Standard error of the mean

Dispersion value

0.44

Secondary: Intraocular Pressure - 3 weeks postoperative

Top of page

End point title

Intraocular Pressure - 3 weeks postoperative

End point description

Intraocular pressure (IOP) was measured using a rebound tonometer (Icare, Finland)

End point type

Secondary

End point timeframe

Three weeks after surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	94	90	92	88
Units: mm Hg
arithmetic mean (confidence interval 95%)	12.1 (11.6 to 12.6)	12.4 (11.9 to 12.9)	11.0 (10.5 to 11.5)	10.6 (10.1 to 11.2)	11.1 (10.6 to 11.6)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

185

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.65

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.34

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8

upper limit

-0.4

Variability estimate

Standard error of the mean

Dispersion value

0.34

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.5

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1

upper limit

-0.8

Variability estimate

Standard error of the mean

Dispersion value

0.34

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.01

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.35

Secondary: Intraocular Pressure - 3 months postoperative

Top of page

End point title

Intraocular Pressure - 3 months postoperative

End point description

Intraocular pressure (IOP) was measured using a rebound tonometer (Icare, Finland).

End point type

Secondary

End point timeframe

Three months after surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	94	90	92	88
Units: mm Hg
arithmetic mean (confidence interval 95%)	11.0 (10.5 to 11.5)	11.2 (10.7 to 11.7)	10.7 (10.2 to 11.2)	10.7 (10.2 to 11.2)	10.8 (10.3 to 11.4)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

185

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.87

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

0.8

Variability estimate

Standard error of the mean

Dispersion value

0.32

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.71

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

0.4

Variability estimate

Standard error of the mean

Dispersion value

0.33

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.65

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

0.3

Variability estimate

Standard error of the mean

Dispersion value

0.33

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.91

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

0.5

Variability estimate

Standard error of the mean

Dispersion value

0.34

Secondary: Number of cells in anterior chamber - 3 days postoperative

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End point title

Number of cells in anterior chamber - 3 days postoperative

End point description

Number of cells in the anterior chamber was coundted in a 1 mm by 1 mm light beam during slit-lamp examination.

End point type

Secondary

End point timeframe

Three days after surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	94	90	92	89
Units: cells
arithmetic mean (confidence interval 95%)	3.4 (3.0 to 3.9)	3.8 (3.3 to 4.4)	4.1 (3.3 to 5.0)	4.0 (3.4 to 4.5)	5.5 (4.5 to 6.7)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Pairwise comparisons were made with control (Pred+NSAID-Pre) using Welchs' two-sample t-test. P-values were adjusted for multiple testing with the False Discovery Rate method. An adjusted p-value < 0.05 was considered statistically significant.

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

185

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.44

Method

Welchs' two-sample t-test

Parameter type

Mean difference (final values)

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

1.1

Variability estimate

Standard error of the mean

Dispersion value

0.35

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.29

Method

Welchs' two-sample t-test

Parameter type

Mean difference (final values)

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

1.7

Variability estimate

Standard error of the mean

Dispersion value

0.47

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.27

Method

Welchs' two-sample t-test

Parameter type

Mean difference (final values)

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

1.3

Variability estimate

Standard error of the mean

Dispersion value

0.35

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

180

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

Welchs' two-sample t-test

Parameter type

Mean difference (final values)

Point estimate

2.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

3.3

Variability estimate

Standard error of the mean

Dispersion value

0.58

Secondary: Corrected Distance Visual Acuity - 3 days postoperative

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End point title

Corrected Distance Visual Acuity - 3 days postoperative

End point description

Corrected Distance Visual Acuity was measured using en ETDRS chart.

End point type

Secondary

End point timeframe

Three days after surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	93	90	92	88
Units: logMAR
arithmetic mean (confidence interval 95%)	0.10 (0.07 to 0.13)	0.10 (0.06 to 0.13)	0.07 (0.03 to 0.10)	0.10 (0.06 to 0.13)	0.11 (0.07 to 0.14)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructure covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

184

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-0.05

upper limit

0.04

Variability estimate

Standard error of the mean

Dispersion value

0.02

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Constrained linear mixed model with an unstructured covariance pattern and inherent baseline adjustment. The model implicitly handled missing values by maximum likelihood estimation. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant. Pairwise comparisons were made with control (Pred+NSAID-Pre).

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.31

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-0.08

upper limit

0.01

Variability estimate

Standard error of the mean

Dispersion value

0.02

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.05

upper limit

0.04

Variability estimate

Standard error of the mean

Dispersion value

0.02

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.95

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-0.04

upper limit

0.05

Variability estimate

Standard error of the mean

Dispersion value

0.02

Secondary: Corrected Distance Visual Acuity - 3 weeks postoperative

Top of page

End point title

Corrected Distance Visual Acuity - 3 weeks postoperative

End point description

Visual acuity was measured using an ETDRS chart.

End point type

Secondary

End point timeframe

Three weeks after cataract surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	93	90	92	88
Units: logMAR
arithmetic mean (confidence interval 95%)	0.02 (-0.01 to 0.05)	0.03 (0.00 to 0.06)	0.02 (-0.02 to 0.04)	0.01 (-0.01 to 0.04)	0.05 (0.02 to 0.08)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

184

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.84

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-0.02

upper limit

0.04

Variability estimate

Standard error of the mean

Dispersion value

0.02

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.03

upper limit

0.03

Variability estimate

Standard error of the mean

Dispersion value

0.02

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.04

upper limit

0.03

Variability estimate

Standard error of the mean

Dispersion value

0.02

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.16

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.03

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.07

Variability estimate

Standard error of the mean

Dispersion value

0.02

Secondary: Corrected Distance Visual Acuity - 3 months postoperative

Top of page

End point title

Corrected Distance Visual Acuity - 3 months postoperative

End point description

Measured using an ETDRS chart.

End point type

Secondary

End point timeframe

Three months after surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	93	90	92	88
Units: logMAR
arithmetic mean (confidence interval 95%)	-0.01 (-0.04 to 0.01)	0.00 (-0.03 to 0.02)	0.00 (-0.03 to 0.02)	-0.01 (-0.04 to 0.01)	0.01 (-0.02 to 0.03)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

184

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.81

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-0.02

upper limit

0.04

Variability estimate

Standard error of the mean

Dispersion value

0.01

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.78

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-0.02

upper limit

0.04

Variability estimate

Standard error of the mean

Dispersion value

0.01

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.03

upper limit

0.03

Variability estimate

Standard error of the mean

Dispersion value

0.01

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.38

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-0.01

upper limit

0.05

Variability estimate

Standard error of the mean

Dispersion value

0.01

Secondary: Subjective Tolerance of Treatment - 3 days postoperative

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End point title

Subjective Tolerance of Treatment - 3 days postoperative

End point description

Participants were asked if they felt “No discomfort or mild discomfort” or “Moderate or severe discomfort”.

End point type

Secondary

End point timeframe

Three days after surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	88	93	87	90	83
Units: participants
number (not applicable)
No or mild discomfort	81	87	82	87	72
Moderate or severe discomfort	7	6	5	3	11

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Pairwise comparisons were made between the control group (Pred+NSAID-Pre) and the comparison groups. P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant.

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Fisher exact

Confidence interval

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Pairwise comparisons were made with control (Pred+NSAID-Pre). P-values were adjusted for multiple testing with the False Discovery Rate method. An adjusted p-value < 0.05 was considered statistically significant.

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

175

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.98

Method

Fisher exact

Confidence interval

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.44

Method

Fisher exact

Confidence interval

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

171

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.61

Method

Fisher exact

Confidence interval

Secondary: Subjective Tolerance of Treatment - 3 weeks postoperative

Top of page

End point title

Subjective Tolerance of Treatment - 3 weeks postoperative

End point description

Participants were asked if they felt “No discomfort or mild discomfort” or “Moderate or severe discomfort”.

End point type

Secondary

End point timeframe

Three weeks after cataract surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	87	93	88	90	83
Units: Participants
number (not applicable)
No or mild discomfort	86	92	85	86	79
Moderate or severe discomfort	1	1	3	4	4

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Pairwise comparisons were made with control (Pred+NSAID-Pre). P-values were adjusted for multiple testing using the False Discovery Rate (FDR) method. An adjusted p-value < 0.05 was considered statistically significant.

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

180

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Fisher exact

Confidence interval

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

175

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.89

Method

Fisher exact

Confidence interval

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.65

Method

Fisher exact

Confidence interval

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

170

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.43

Method

Fisher exact

Confidence interval

Secondary: Average Retinal Nerve Fiber Layer Thickness - 3 weeks postoperative

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End point title

Average Retinal Nerve Fiber Layer Thickness - 3 weeks postoperative

End point description

Retinal Nerve Fiber Layer thickness was measured by peripapillary optical coherence tomography (OCT, DRI OCT Triton, Topcon Europe Medical BV) and obtained from the in-build software (IMAGEnet 6, Topcon Europe Medical BV)

End point type

Secondary

End point timeframe

Three weeks after cataract surgery

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	92	88	91	89
Units: micrometers
arithmetic mean (confidence interval 95%)	99.4 (97.8 to 101.1)	98.5 (96.9 to 100.0)	98.0 (96.4 to 99.6)	97.6 (96.0 to 99.2)	102.8 (101.1 to 104.4)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.67

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

1.3

Variability estimate

Standard error of the mean

Dispersion value

1.1

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.44

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.5

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

0.8

Variability estimate

Standard error of the mean

Dispersion value

1.2

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.27

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-4.1

upper limit

0.4

Variability estimate

Standard error of the mean

Dispersion value

1.1

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

180

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.01

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

3.3

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

5.6

Variability estimate

Standard error of the mean

Dispersion value

1.2

Secondary: Average Retinal Nerve Fiber Layer Thickness - 3 months postoperative

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End point title

Average Retinal Nerve Fiber Layer Thickness - 3 months postoperative

End point description

End point type

Secondary

End point timeframe

Three months after cataract surgery.

End point values	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Number of subjects analysed	91	92	88	91	89
Units: micrometers
arithmetic mean (confidence interval 95%)	99.8 (98.1 to 101.4)	99.3 (97.7 to 101.0)	97.7 (96.0 to 99.4)	98.0 (96.4 to 99.7)	98.6 (96.9 to 100.3)

Pred+NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Pred+NSAID-Post

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.95

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

1.9

Variability estimate

Standard error of the mean

Dispersion value

1.2

NSAID-Pre vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Pre

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.19

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-2.1

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

0.3

Variability estimate

Standard error of the mean

Dispersion value

1.2

NSAID-Post vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v NSAID-Post

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.31

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

0.6

Variability estimate

Standard error of the mean

Dispersion value

1.2

Dropless vs. Pred+NSAID-Pre

Statistical analysis description

Comparison groups

Pred+NSAID-Pre v Drop-less

Number of subjects included in analysis

180

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.64

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

1.2

Variability estimate

Standard error of the mean

Dispersion value

1.2

Adverse events

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Timeframe for reporting adverse events

Adverse events were assessed for each participant from inclusion until completion of/termination from study.

Adverse event reporting additional description

Patients were asked for symptoms and adverse events at each postoperative visit and patient journals were investigated for records of adverse events.

Assessment type

Systematic

Dictionary name

Not applicable

Dictionary version

Reporting group title

Pred+NSAID-Pre

Reporting group description

Combination of prednisolone- and ketorolac eye drops three times per day until three weeks after surgery with initiation three days before surgery

Reporting group title

Pred+NSAID-Post

Reporting group description

Combination of prednisolone- and ketorolac eye drops three times per day until three weeks after surgery with initiation on the day of surgery

Reporting group title

NSAID-Pre

Reporting group description

Monotherapy with ketorolac eye drops three times per day until three weeks after surgery with initiation three days before surgery

Reporting group title

NSAID-Post

Reporting group description

Monotherapy with ketorolac eye drops three times per day until three weeks after surgery with initiation on the day of surgery

Reporting group title

Drop-less

Reporting group description

Subtenon depot of 0.5 mL dexamethasone phosphate administered at the conclusion of cataract surgery

Serious adverse events	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 89 (1.12%)	3 / 93 (3.23%)	1 / 91 (1.10%)	3 / 91 (3.30%)	5 / 87 (5.75%)
number of deaths (all causes)	0	0	0	0	1
number of deaths resulting from adverse events	0	0	0	0	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
Additional description: Hospitalized due to abdominal pain. Examinations showed ascites and disseminated pancreatic cancer. Died in relation to exploratory laparatomy. Had not received any investigational medicine.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	1 / 87 (1.15%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Vascular disorders
Orthostatic hypotension
Additional description: Tendency to fall. Previous cerebral apoplexia. Hospitalized due to social circumstances. Found to have orthostatic hypotension.
subjects affected / exposed	1 / 89 (1.12%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	0 / 87 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Syncope
Additional description: Hospitalized due to low bloodpressure and syncope/fainting. Known to have ischemic heart disease and ICD-pacemaker. Had not been given any study medication.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	1 / 87 (1.15%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
Additional description: Hospitalized due to paroxystic atrial fibrilation. Had not received any study medication.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	1 / 91 (1.10%)	0 / 91 (0.00%)	0 / 87 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac arrest
Additional description: Witnessed cardiac arrest, defibrillated twice and return of spontaneous circulation after 5 minutes. Hospitalized and treated with percutan cardiac intervention (PCI). Alive and well.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	1 / 91 (1.10%)	0 / 87 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebral infarction
Additional description: Hospitalized due to sudden loss of balance and control of the left arm. Had not received any study medication.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	1 / 87 (1.15%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral artery occlusion
Additional description: Sudden debut of aphasia and hemiparesis. Examinations showed occlusion of two cerebral arteries.
subjects affected / exposed	1 / 89 (1.12%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	0 / 87 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Amaurosis fugax
Additional description: Sudden pain and distorted vision/loss of vision on the right eye for 5-10 minutes, no symptoms afterwards. Hospitalized for further examinations.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	1 / 87 (1.15%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Retinal detachment
Additional description: Surgically treated for retinal detachment following cataract surgery.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	1 / 91 (1.10%)	0 / 87 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Gastric ulcer
Additional description: Patient with known liver cirrhosis hospitalized due to suspected bleeding esophagal varices. Endoscopic examination showed a non-bleeding esophagal varice and two fibrin covered gastric ulcera.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	1 / 87 (1.15%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Erysipelas
Additional description: Hospitalized for antibiotic treatment of erysipelas. Had not received any study medication.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	1 / 91 (1.10%)	0 / 87 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Ureteric perforation
Additional description: Was hospitalized due to acute abdominal pain, nausia and vomiting. Was found to have a ureteric perforation and was surgically treated.
subjects affected / exposed	0 / 89 (0.00%)	1 / 93 (1.08%)	0 / 91 (0.00%)	0 / 91 (0.00%)	0 / 87 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cystitis
Additional description: Hospitalized for antibiotic treatment
subjects affected / exposed	0 / 89 (0.00%)	1 / 93 (1.08%)	0 / 91 (0.00%)	0 / 91 (0.00%)	0 / 87 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Pain in extremity
Additional description: Hospitalized due to severe pain and cramps in upper and lower extremities.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	1 / 87 (1.15%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Syncope
Additional description: Syncope due to dehydration after physical work in the sun. Was hospitalized and rehydrated.
subjects affected / exposed	0 / 89 (0.00%)	1 / 93 (1.08%)	0 / 91 (0.00%)	0 / 91 (0.00%)	0 / 87 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Pred+NSAID-Pre	Pred+NSAID-Post	NSAID-Pre	NSAID-Post	Drop-less
Total subjects affected by non serious adverse events
subjects affected / exposed	23 / 89 (25.84%)	36 / 93 (38.71%)	30 / 91 (32.97%)	31 / 91 (34.07%)	68 / 87 (78.16%)
Surgical and medical procedures
Burning sensation
Additional description: Burning sensation/pain when subtenon depot was applied
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	13 / 87 (14.94%)
occurrences all number	23	36	31	30	68
Pain
Additional description: Pain/soreness during cataract surgery
subjects affected / exposed	0 / 89 (0.00%)	2 / 93 (2.15%)	0 / 91 (0.00%)	0 / 91 (0.00%)	2 / 87 (2.30%)
occurrences all number	23	36	31	30	68
Intraocular lens repositioning
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	1 / 91 (1.10%)	1 / 87 (1.15%)
occurrences all number	23	36	31	30	68
Lens dislocation
Additional description: Retained lens fragments in the anterior chamber after cataract surgery and need for surgical removal.
subjects affected / exposed	1 / 89 (1.12%)	0 / 93 (0.00%)	0 / 91 (0.00%)	0 / 91 (0.00%)	3 / 87 (3.45%)
occurrences all number	23	36	31	30	68
Posterior capsule rupture
Additional description: Rupture of the posterior capsule during phacoemulsification.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	2 / 91 (2.20%)	0 / 91 (0.00%)	0 / 87 (0.00%)
occurrences all number	23	36	31	30	68
Nervous system disorders
Headache
subjects affected / exposed	1 / 89 (1.12%)	0 / 93 (0.00%)	2 / 91 (2.20%)	2 / 91 (2.20%)	4 / 87 (4.60%)
occurrences all number	23	36	31	30	68
Nausea
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	1 / 91 (1.10%)	1 / 91 (1.10%)	2 / 87 (2.30%)
occurrences all number	23	36	31	30	68
General disorders and administration site conditions
Malaise
Additional description: Malaise immediately after cataract surgery.
subjects affected / exposed	0 / 89 (0.00%)	1 / 93 (1.08%)	0 / 91 (0.00%)	0 / 91 (0.00%)	1 / 87 (1.15%)
occurrences all number	23	36	31	30	68
Eye disorders
Pain
Additional description: Pain or soreness in the eye during the postoperative period
subjects affected / exposed	2 / 89 (2.25%)	0 / 93 (0.00%)	1 / 91 (1.10%)	0 / 91 (0.00%)	13 / 87 (14.94%)
occurrences all number	23	36	31	30	68
Inflammation
Additional description: Insufficiently controlled intraocular reaction / inflammation in the anterior chamber.
subjects affected / exposed	2 / 89 (2.25%)	5 / 93 (5.38%)	5 / 91 (5.49%)	4 / 91 (4.40%)	40 / 87 (45.98%)
occurrences all number	23	36	31	30	68
Dry eye
Additional description: Dry eye symptoms that needed additional lubricating treatment.
subjects affected / exposed	7 / 89 (7.87%)	18 / 93 (19.35%)	13 / 91 (14.29%)	14 / 91 (15.38%)	23 / 87 (26.44%)
occurrences all number	23	36	31	30	68
Macular cyst
Additional description: One or more cysts present on macular optical coherence tomography (OCT).
subjects affected / exposed	2 / 89 (2.25%)	3 / 93 (3.23%)	4 / 91 (4.40%)	0 / 91 (0.00%)	11 / 87 (12.64%)
occurrences all number	23	36	31	30	68
Blepharitis
Additional description: Blepharitis was noted as an adverse event if it was found at a postoperative visit and the patient was not previously treated for blepharitis.
subjects affected / exposed	1 / 89 (1.12%)	2 / 93 (2.15%)	3 / 91 (3.30%)	2 / 91 (2.20%)	1 / 87 (1.15%)
occurrences all number	23	36	31	30	68
Corneal abrasion
subjects affected / exposed	3 / 89 (3.37%)	1 / 93 (1.08%)	0 / 91 (0.00%)	4 / 91 (4.40%)	3 / 87 (3.45%)
occurrences all number	23	36	31	30	68
Intraocular pressure increased
Additional description: Elevated intraocular pressure > 25 mm Hg immediately after cataract surgery.
subjects affected / exposed	0 / 89 (0.00%)	1 / 93 (1.08%)	0 / 91 (0.00%)	1 / 91 (1.10%)	0 / 87 (0.00%)
occurrences all number	23	36	31	30	68
Corneal oedema
Additional description: Significant corneal oedema after cataract surgery.
subjects affected / exposed	4 / 89 (4.49%)	3 / 93 (3.23%)	1 / 91 (1.10%)	2 / 91 (2.20%)	4 / 87 (4.60%)
occurrences all number	23	36	31	30	68
Skin and subcutaneous tissue disorders
Skin irritation
Additional description: Itching in palms and feet.
subjects affected / exposed	0 / 89 (0.00%)	1 / 93 (1.08%)	0 / 91 (0.00%)	0 / 91 (0.00%)	0 / 87 (0.00%)
occurrences all number	23	36	31	30	68
Skin reaction
Additional description: Edema and / or redness of the skin surrounding the eye
subjects affected / exposed	2 / 89 (2.25%)	0 / 93 (0.00%)	1 / 91 (1.10%)	1 / 91 (1.10%)	1 / 87 (1.15%)
occurrences all number	23	36	31	30	68
Musculoskeletal and connective tissue disorders
Fracture
Additional description: Fracture of an extremity during participation in the study.
subjects affected / exposed	0 / 89 (0.00%)	1 / 93 (1.08%)	0 / 91 (0.00%)	0 / 91 (0.00%)	2 / 87 (2.30%)
occurrences all number	23	36	31	30	68
Pain
Additional description: Muscular pain in extremities or lower back.
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	1 / 91 (1.10%)	2 / 91 (2.20%)	2 / 87 (2.30%)
occurrences all number	23	36	31	30	68
Infections and infestations
Viral infection
Additional description: Common cold
subjects affected / exposed	0 / 89 (0.00%)	1 / 93 (1.08%)	0 / 91 (0.00%)	0 / 91 (0.00%)	1 / 87 (1.15%)
occurrences all number	23	36	31	30	68
Gastroenteritis
subjects affected / exposed	0 / 89 (0.00%)	0 / 93 (0.00%)	0 / 91 (0.00%)	1 / 91 (1.10%)	1 / 87 (1.15%)
occurrences all number	23	36	31	30	68
Cystitis
subjects affected / exposed	1 / 89 (1.12%)	1 / 93 (1.08%)	0 / 91 (0.00%)	1 / 91 (1.10%)	0 / 87 (0.00%)
occurrences all number	23	36	31	30	68

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/33086290

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Clinical trials

Clinical Trial Results: Effect of drop-less surgery compared to topical NSAID alone and combination of steroid and NSAID on central macular thickness after cataract surgery, a randomized controlled trial

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Central Macular Thickness 3 months postoperative

Primary: Central Macular Thickness 3 months postoperative

Secondary: Central macular thickness 3 weeks postoperative

Secondary: Central macular thickness 3 weeks postoperative

Secondary: Anterior Chamber Flare at 3 days postoperative

Secondary: Anterior Chamber Flare at 3 days postoperative

Secondary: Intraocular Pressure - 3 days postoperative

Secondary: Intraocular Pressure - 3 days postoperative

Secondary: Intraocular Pressure - 3 weeks postoperative

Secondary: Intraocular Pressure - 3 weeks postoperative

Secondary: Intraocular Pressure - 3 months postoperative

Secondary: Intraocular Pressure - 3 months postoperative

Secondary: Number of cells in anterior chamber - 3 days postoperative

Secondary: Number of cells in anterior chamber - 3 days postoperative

Secondary: Corrected Distance Visual Acuity - 3 days postoperative

Secondary: Corrected Distance Visual Acuity - 3 days postoperative

Secondary: Corrected Distance Visual Acuity - 3 weeks postoperative

Secondary: Corrected Distance Visual Acuity - 3 weeks postoperative

Secondary: Corrected Distance Visual Acuity - 3 months postoperative

Secondary: Corrected Distance Visual Acuity - 3 months postoperative

Secondary: Subjective Tolerance of Treatment - 3 days postoperative

Secondary: Subjective Tolerance of Treatment - 3 days postoperative

Secondary: Subjective Tolerance of Treatment - 3 weeks postoperative

Secondary: Subjective Tolerance of Treatment - 3 weeks postoperative

Secondary: Average Retinal Nerve Fiber Layer Thickness - 3 weeks postoperative

Secondary: Average Retinal Nerve Fiber Layer Thickness - 3 weeks postoperative

Secondary: Average Retinal Nerve Fiber Layer Thickness - 3 months postoperative

Secondary: Average Retinal Nerve Fiber Layer Thickness - 3 months postoperative

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
Effect of drop-less surgery compared to topical NSAID alone and combination of steroid and NSAID on central macular thickness after cataract surgery, a randomized controlled trial