Clinical Trial Results:
Effects of post-operative topical steroid versus intraoperative subconjunctival steroid injection and postoperative miotic on intraocular inflammation following cataract extraction.
Summary
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EudraCT number |
2006-001486-41 |
Trial protocol |
NL |
Global end of trial date |
30 Nov 2010
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Results information
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Results version number |
v2(current) |
This version publication date |
02 Feb 2016
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First version publication date |
28 Dec 2014
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
OZR-2006-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Nederlands Trial Register: NTR779 | ||
Sponsors
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Sponsor organisation name |
The Rotterdam Eye Hospital
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Sponsor organisation address |
PO Box 70030, Rotterdam, Netherlands, 3000LM
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Public contact |
Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 4023449, roi@oogziekenhuis.nl
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Scientific contact |
Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 4023449, roi@oogziekenhuis.nl
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Apr 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Nov 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Nov 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Comparison of incidence of post-cataract extraction ocular inflammation with subconjunctival steroid injection versus traditional eye drops.
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Protection of trial subjects |
No specific measures.
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Background therapy |
Cataract extraction is the most frequently performed surgical intervention. A relatively high prevalence of post-op ocular inflammation, needing additional treatment and visits, has prompted the search for a treatment to replace the traditionally prescribed topical steroids. A subconjunctival steroid depot was compared with traditional prophylaxis. (Dieleman M, Wubbels RJ, van Kooten-Noordzij M, de Waard PWT. Single perioperative subconjunctival steroid depot versus postoperative steroid eyedrops to prevent intraocular inflammation and macular edema after cataract surgery. J Cataract Refract Surg, 37, 1589-1597.) The use of miotics after cataract extraction appears to have lost its rationale. Therefore, as a secondary objective of this study, the efficacy of Eserine has been evaluated. (Dieleman M, Wubbels RJ, de Waard PWT. Miotics after modern cataract surgery are history. J Ocul Pharmacol Ther, 28, 98-101.) | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Jan 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 400
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Worldwide total number of subjects |
400
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EEA total number of subjects |
400
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
97
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From 65 to 84 years |
281
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85 years and over |
22
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Recruitment
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Recruitment details |
Patients indicated for cataract surgery (age > 18 years). | |||||||||
Pre-assignment
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Screening details |
Subcapsular posterior cataract (very soft, short phaco time). Brunescens or mature cataract (hard, long phaco time). | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Subconjunctival betamethasone | |||||||||
Arm description |
Subconjunctival betamethasone | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Betamethasone
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Investigational medicinal product code |
RVG05399
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Other name |
Celestone chronodose
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Subconjunctival use
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Dosage and administration details |
Single perioperative subconjunctival injection, 2.7 mg (1 ml).
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Arm title
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Eye drops dexamethasone | |||||||||
Arm description |
Eye drops dexamethasone | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Dexamethasone
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Investigational medicinal product code |
RVG56003
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Other name |
Dexamethason ratiopharm
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Pharmaceutical forms |
Ear/eye drops, solution
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Routes of administration |
Topical use
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Dosage and administration details |
Eye drops, 3X per day, 3 weeks postop (1 mg/mlo).
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Baseline characteristics reporting groups
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Reporting group title |
Subconjunctival betamethasone
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Reporting group description |
Subconjunctival betamethasone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Eye drops dexamethasone
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Reporting group description |
Eye drops dexamethasone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Subconjunctival betamethasone
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Reporting group description |
Subconjunctival betamethasone | ||
Reporting group title |
Eye drops dexamethasone
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Reporting group description |
Eye drops dexamethasone | ||
Subject analysis set title |
Mann-Whitney U test for flare measurements
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Mann-Whitney U test for flare measurements
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End point title |
Flare count (photons/ms) at 4 weeks postop. | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
4 weeks postop.
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Statistical analysis title |
Mann-Whitney U | ||||||||||||
Comparison groups |
Subconjunctival betamethasone v Eye drops dexamethasone
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Number of subjects included in analysis |
400
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Four weeks postop.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
Subconjunctival betamehtasone
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
Reporting group title |
Eye drops dexamethasone
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The reported difference between the flare counts of both groups is statistically significant but "the question remains as to whether this reflects a clinically significant difference." | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/21855759 http://www.ncbi.nlm.nih.gov/pubmed/22029576 |