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    Clinical Trial Results:
    Effects of post-operative topical steroid versus intraoperative subconjunctival steroid injection and postoperative miotic on intraocular inflammation following cataract extraction.

    Summary
    EudraCT number
    		 2006-001486-41
    Trial protocol
    		 NL  
    Global end of trial date
    30 Nov 2010

    Results information
    Results version number
    		 v1
    This version publication date
    02 Feb 2016
    First version publication date
    28 Dec 2014
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    OZR-2006-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Nederlands Trial Register: NTR779
    Sponsors
    Sponsor organisation name
    The Rotterdam Eye Hospital
    Sponsor organisation address
    PO Box 70030, Rotterdam, Netherlands, 3000LM
    Public contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 4023449, roi@oogziekenhuis.nl
    Scientific contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 4023449, roi@oogziekenhuis.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 Apr 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison of incidence of post-cataract extraction ocular inflammation with subconjunctival steroid injection versus traditional eye drops.
    Protection of trial subjects
    No specific measures.
    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
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 400
    Worldwide total number of subjects
    400
    EEA total number of subjects
    400
    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)
    97
    From 65 to 84 years
    281
    85 years and over
    22

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients indicated for cataract surgery (age > 18 years).

    Pre-assignment
    Screening details
    		 Subcapsular posterior cataract (very soft, short phaco time). Brunescens or mature cataract (hard, long phaco time).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Subconjunctival betamethasone
    Arm description
    		 Subconjunctival betamethasone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Betamethasone
    Investigational medicinal product code
    RVG05399
    Other name
    Celestone chronodose
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subconjunctival use
    Dosage and administration details
    Single perioperative subconjunctival injection, 2.7 mg (1 ml).

    Arm title
    		 Eye drops dexamethasone
    Arm description
    		 Eye drops dexamethasone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    RVG56003
    Other name
    Dexamethason ratiopharm
    Pharmaceutical forms
    Ear/eye drops, solution
    Routes of administration
    Topical use
    Dosage and administration details
    Eye drops, 3X per day, 3 weeks postop (1 mg/mlo).

    Number of subjects in period 1
    		Subconjunctival betamethasone Eye drops dexamethasone
    Started
    200
    200
    Completed
    200
    200

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Subconjunctival betamethasone
    Reporting group description
    		 Subconjunctival betamethasone

    Reporting group title
    Eye drops dexamethasone
    Reporting group description
    		 Eye drops dexamethasone

    Reporting group values
    		 Subconjunctival betamethasone Eye drops dexamethasone Total
    Number of subjects
    		 200 200 400
    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
        arithmetic mean (standard deviation)
    		 72.3 ± 9.6 69.3 ± 9.2 -
    Gender categorical
    Units: Subjects
        Female
    		 127 115 242
        Male
    		 73 85 158

    End points

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    End points reporting groups
    Reporting group title
    Subconjunctival betamethasone
    Reporting group description
    		 Subconjunctival betamethasone

    Reporting group title
    Eye drops dexamethasone
    Reporting group description
    		 Eye drops dexamethasone

    Subject analysis set title
    Mann-Whitney U test for flare measurements
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Mann-Whitney U test for flare measurements

    Primary: Flare count (photons/ms) at 4 weeks postop.

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    End point title
    		 Flare count (photons/ms) at 4 weeks postop.
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks postop.
    End point values
    		 Subconjunctival betamethasone Eye drops dexamethasone
    Number of subjects analysed
    200
    200
    Units: photons per ms
        arithmetic mean (standard deviation)
    10.8 ± 7.2
    9.9 ± 9.5
    Statistical analysis title
    		 Mann-Whitney U
    Comparison groups
    Subconjunctival betamethasone v Eye drops dexamethasone
    Number of subjects included in analysis
    400
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Four weeks postop.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Subconjunctival betamehtasone
    Reporting group description
    		 -

    Reporting group title
    Eye drops dexamethasone
    Reporting group description
    		 -

    Serious adverse events
    		 Subconjunctival betamehtasone Eye drops dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 200 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Subconjunctival betamehtasone Eye drops dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 200 (11.00%)
    27 / 200 (13.50%)
    Eye disorders
    Clinical significant macular edema
         subjects affected / exposed
    4 / 200 (2.00%)
    7 / 200 (3.50%)
         occurrences all number
    4
    7
    Intraocular pressure > 30 mm Hg
         subjects affected / exposed
    2 / 200 (1.00%)
    3 / 200 (1.50%)
         occurrences all number
    2
    3
    Subconjunctival hemorrhage
         subjects affected / exposed
    16 / 200 (8.00%)
    17 / 200 (8.50%)
         occurrences all number
    16
    17

    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.
    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
    http://www.ncbi.nlm.nih.gov/pubmed/21855759
    http://www.ncbi.nlm.nih.gov/pubmed/2202957
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    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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