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    Clinical Trial Results:
    Effectiveness of Periocular drug Injection in CATaract surgery

    Summary
    EudraCT number
    		 2019-004890-21
    Trial protocol
    		 NL   DE   AT   PT  
    Global end of trial date
    13 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2025
    First version publication date
    03 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NL72427.068.19
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Academic Hospital Maastricht (azM)
    Sponsor organisation address
    P. Debyelaan 25, Maastricht, Netherlands,
    Public contact
    Dr. N. Visser, MD, PhD, Academic Hospital Maastricht (azM), 0031 (0)433875347, nienke.visser@mumc.nl
    Scientific contact
    Dr. N. Visser, MD, PhD, Academic Hospital Maastricht (azM), 0031 (0)433875347, nienke.visser@mumc.nl
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Dec 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the effectiveness of different treatments to prevent CME after cataract surgery, using either topical drugs (control group) or intra-/periocular injections (intervention groups).
    Protection of trial subjects
    All medicines used are registered for ophthalmic use in patients undergoing cataract surgery. Overall side effects are mild and uncommon and are described in the SPC’s and IB.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 520
    Country: Number of subjects enrolled
    Portugal: 9
    Country: Number of subjects enrolled
    Austria: 85
    Country: Number of subjects enrolled
    Germany: 14
    Worldwide total number of subjects
    628
    EEA total number of subjects
    628
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    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)
    126
    From 65 to 84 years
    488
    85 years and over
    14

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrolment took place from 13-10-2021 until 13-08-2024 in The Netherlands, Germany, Austria and Portugal.

    Pre-assignment
    Screening details
    		 Diagnosis and main criteria for inclusion: Patients aged 21 years or older who require cataract surgery in at least one eye.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control group
    Arm description
    		 Control group: topical bromfenac 0.09% and topical dexamethasone disodium phosphate 0.1% started 2 days preoperatively and continued postoperatively
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Yellox 0.9 mg/ml eye drops solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Bromfenac 0.09% ophthalmic solution

    Investigational medicinal product name
    Dexamethason 1 mg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Dexamethasone 0.1% ophthalmic suspension

    Arm title
    		 Intervention group 1
    Arm description
    		 Intervention group 1: subconjunctival injection of 10 mg triamcinolone acetonide (TA) during cataract surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triamcinolone Acetonide 40 mg/ml solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subconjunctival use
    Dosage and administration details
    subconjunctival injection of 10 mg triamcinolone acetonide (TA) during cataract surgery

    Arm title
    		 Intervention group 2
    Arm description
    		 Intervention group 2: intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketorolac tromethamine (0.023mg/mL) solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intracameral use
    Dosage and administration details
    : intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery

    Arm title
    		 Intervention group 3
    Arm description
    		 Intervention group 3: subconjunctival injection of 10 mg TA and intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triamcinolone Acetonide 40 mg/ml solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subconjunctival use
    Dosage and administration details
    subconjunctival injection of 10 mg triamcinolone acetonide (TA) during cataract surgery

    Investigational medicinal product name
    Ketorolac tromethamine (0.023mg/mL) solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intracameral use
    Dosage and administration details
    : intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery

    Number of subjects in period 1 [1]
    		Control group Intervention group 1 Intervention group 2 Intervention group 3
    Started
    156
    159
    158
    153
    Completed
    150
    144
    147
    136
    Not completed
    6
    15
    11
    17
         study medication not available, excluded on... etc
    6
    15
    11
    17
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 2 patients were excluded after enrollment, but before randomization

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Control group: topical bromfenac 0.09% and topical dexamethasone disodium phosphate 0.1% started 2 days preoperatively and continued postoperatively

    Reporting group title
    Intervention group 1
    Reporting group description
    		 Intervention group 1: subconjunctival injection of 10 mg triamcinolone acetonide (TA) during cataract surgery

    Reporting group title
    Intervention group 2
    Reporting group description
    		 Intervention group 2: intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery

    Reporting group title
    Intervention group 3
    Reporting group description
    		 Intervention group 3: subconjunctival injection of 10 mg TA and intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery

    Reporting group values
    		 Control group Intervention group 1 Intervention group 2 Intervention group 3 Total
    Number of subjects
    		 156 159 158 153 626
    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
    Units: years
        geometric mean (standard deviation)
    		 71 ( 7.9 ) 70 ( 8.1 ) 71 ( 8.0 ) 70 ( 9.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 82 81 73 75 311
        Male
    		 74 78 85 78 315
    Ethnicity
    Units: Subjects
        Caucasian
    		 151 155 155 152 613
        African
    		 0 1 0 1 2
        Asian
    		 2 1 1 0 4
        Other
    		 1 2 1 0 4
        Unknown
    		 2 0 1 0 3
    Hypertension
    Units: Subjects
        No
    		 92 78 82 81 333
        Yes
    		 64 80 75 69 288
        Unknown
    		 0 1 1 3 5
    Smoker
    Units: Subjects
        Non smoker
    		 57 65 67 51 240
        Current smoker
    		 21 18 26 24 89
        Former smoker
    		 75 75 63 75 288
        Unknown
    		 3 1 2 3 9
    Hypercholesterolemia
    Units: Subjects
        No
    		 114 102 104 98 418
        Yes
    		 42 56 53 52 203
        Unknown
    		 0 1 1 3 5
    Cataract type
    Units: Subjects
        Nuclear
    		 65 47 59 59 230
        Cortical
    		 2 4 2 3 11
        Capsular
    		 0 1 1 1 3
        Polar
    		 0 0 0 1 1
        Mature+Cortical+Nuclear
    		 0 1 0 0 1
        Phakic
    		 0 1 0 0 1
        Nuclear+Polar
    		 0 0 1 0 1
        Nuclear+Cortical+Capsular
    		 14 14 10 11 49
        Cortical+Capsular
    		 1 2 1 1 5
        Nuclear+Capsular
    		 5 10 13 9 37
        Nuclear+Cortical
    		 68 77 67 65 277
        Unknown
    		 1 2 4 3 10
    Cataract intensity LOCS III - Nuclear color
    Units: LOCS III
        geometric mean (standard deviation)
    		 3.24 ( 0.98 ) 3.08 ( 0.96 ) 3.08 ( 0.90 ) 3.13 ( 0.89 ) -
    Cataract intensity LOCS III - Nuclear opalescence
    Units: LOCS III
        geometric mean (standard deviation)
    		 2.76 ( 0.82 ) 2.76 ( 0.87 ) 2.76 ( 0.79 ) 2.72 ( 0.84 ) -
    Cataract intensity LOCS III - Cortical
    Units: LOCS III
        geometric mean (standard deviation)
    		 2.13 ( 1.05 ) 2.25 ( 1.14 ) 2.14 ( 1.19 ) 2.17 ( 1.19 ) -
    Cataract intensity LOCS III - Posterior
    Units: LOCS III
        geometric mean (standard deviation)
    		 1.34 ( 0.83 ) 1.44 ( 0.95 ) 1.55 ( 1.12 ) 1.42 ( 0.96 ) -

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Control group: topical bromfenac 0.09% and topical dexamethasone disodium phosphate 0.1% started 2 days preoperatively and continued postoperatively

    Reporting group title
    Intervention group 1
    Reporting group description
    		 Intervention group 1: subconjunctival injection of 10 mg triamcinolone acetonide (TA) during cataract surgery

    Reporting group title
    Intervention group 2
    Reporting group description
    		 Intervention group 2: intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery

    Reporting group title
    Intervention group 3
    Reporting group description
    		 Intervention group 3: subconjunctival injection of 10 mg TA and intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery

    Primary: CSMT 6 weeks

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    End point title
    		 CSMT 6 weeks
    End point description
    End point type
    Primary
    End point timeframe
    baseline to 6 weeks
    End point values
    		 Control group Intervention group 1 Intervention group 2 Intervention group 3
    Number of subjects analysed
    146
    142
    140
    130
    Units: µm
        arithmetic mean (standard deviation)
    8.37 ( 18.14 )
    6.90 ( 18.46 )
    36.69 ( 67.30 )
    7.26 ( 11.30 )
    Statistical analysis title
    		 Treatment effects
    Statistical analysis description
    Linear Mixed Model for calculating treatment effect between groups at 6 weeks. This is based on the mean values of CSMT at 6 weeks (not change score).
    Comparison groups
    Control group v Intervention group 1 v Intervention group 2 v Intervention group 3
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0.05 [2]
    Method
    		 equality
    Parameter type
    		 Treatment effect
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [1] - The fixed effects in the model consisted of time, time*treatment, center, center*time, and center*time*treatment.
    [2] - A significance threshold of P≤0.05 was used, and following Bonferroni correction, a significance level of P≤0.00833 was applied for testing across 4 study groups.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion until 12 weeks after operation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Control group: topical bromfenac 0.09% and topical dexamethasone disodium phosphate 0.1% started 2 days preoperatively and continued postoperatively

    Reporting group title
    Intervention group 1
    Reporting group description
    		 Intervention group 1: subconjunctival injection of 10 mg triamcinolone acetonide (TA) during cataract surgery

    Reporting group title
    Intervention group 2
    Reporting group description
    		 Intervention group 2: intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery

    Reporting group title
    Intervention group 3
    Reporting group description
    		 Intervention group 3: subconjunctival injection of 10 mg TA and intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery

    Serious adverse events
    		 Control group Intervention group 1 Intervention group 2 Intervention group 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 156 (2.56%)
    2 / 159 (1.26%)
    3 / 158 (1.90%)
    1 / 153 (0.65%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
    Additional description: Fall from roof
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Syncope
    Additional description: Syncope during arterial hypotension of unknown origin
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
    Additional description: Retinal detachment with hospital admission
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic neuropathy
    Additional description: Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) non study eye
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urosepsis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control group Intervention group 1 Intervention group 2 Intervention group 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 156 (21.15%)
    39 / 159 (24.53%)
    74 / 158 (46.84%)
    41 / 153 (26.80%)
    Eye disorders
    Dry eye
         subjects affected / exposed
    27 / 156 (17.31%)
    35 / 159 (22.01%)
    49 / 158 (31.01%)
    30 / 153 (19.61%)
         occurrences all number
    27
    35
    49
    30
    Corneal oedema
         subjects affected / exposed
    5 / 156 (3.21%)
    6 / 159 (3.77%)
    14 / 158 (8.86%)
    10 / 153 (6.54%)
         occurrences all number
    5
    6
    14
    10
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 156 (0.64%)
    3 / 159 (1.89%)
    22 / 158 (13.92%)
    7 / 153 (4.58%)
         occurrences all number
    1
    3
    22
    7
    Photophobia
         subjects affected / exposed
    4 / 156 (2.56%)
    7 / 159 (4.40%)
    13 / 158 (8.23%)
    1 / 153 (0.65%)
         occurrences all number
    4
    7
    13
    1
    Anterior chamber cells/Uveitis
         subjects affected / exposed
    2 / 156 (1.28%)
    0 / 159 (0.00%)
    12 / 158 (7.59%)
    1 / 153 (0.65%)
         occurrences all number
    2
    0
    12
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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