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ISRCTN
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ISRCTN02628492
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ClinicalTrials.gov identifier
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Public title
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Prevention of post-cataract surgery macula oedema with prophylactic ketorolac
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Scientific title
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Prevention of pseudophakic cystoid macula oedema with pre- and post-operative ketorolac
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Acronym
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N/A
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Serial number at source
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1.2
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Study hypothesis
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To assess whether patients treated with ketorolac 3 days pre- and 3 weeks post-operatively in combination with post-operative steroid drops have a lower incidence of cystoid macula oedema (CMO) following cataract surgery than those receiving standard clinical care (pre-operative topical flurbiprofen 1 hour prior to surgery and post-operative steroid drops).
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Ethics approval
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Ethics approval pending as of 07/07/2008. London-Surrey Borders ethics committee will be meeting on 9th July 2008.
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Study design
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Single-blind randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cystoid macular oedema (CMO)
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Participants - inclusion criteria
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1. Patients undergoing routine cataract surgery without an additional procedure
2. Patients with risk factors for developing CMO, such as pre-existing diabetes
3. Aged 18 to 75 years, male and female
Patients with epiretinal membranes or age-related macular degeneration (ARMD) will be analysed separately.
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Participants - exclusion criteria
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1. Patients who have previously had a reaction to ketorolac
2. Patients who are on systemic non-steroidal anti-inflammatories or steroids
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Anticipated start date
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12/07/2008
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Anticipated end date
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12/10/2009
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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1400
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Interventions
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1. Intervention: ketorolac eye drops (0.4%) - 1 eye drop 4 times a day for 3 days before the operation and 3 weeks after the operation
2. Control arm: usual clinical care - 1 drop of flurbiprofen eye drop 1 hour before surgery and Maxidex® eye drop three times a day for 3 weeks post-cataract surgery
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Primary outcome measure(s)
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Central macula thickness as measured on optical coherence tomography.
The primary and secondary outcomes will be measured at baseline (prior to surgery), 1 month after surgery, 2 months after surgery and 3 months after surgery.
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Secondary outcome measure(s)
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1. Logarithmic minimal angle of resolution (LogMAR) visual acuity
2. Contrast sensitivity
3. Adverse events
The primary and secondary outcomes will be measured at baseline (prior to surgery), 1 month after surgery, 2 months after surgery and 3 months after surgery.
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Sources of funding
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Frimley Park Hospital NHS Foundation Trust (UK) - Ophthalmology Research Funding will cover any extra costs incurred
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Trial website
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Publications
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Contact name
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Mrs
Geeta
Menon
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Address
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Frimley Park Hospital NHS Foundation Trust
Portsmouth Road
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City/town
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Frimley
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Zip/Postcode
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GU16 7UJ
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Country
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United Kingdom
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Sponsor
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Frimley Park Hospital NHS Foundation Trust (UK)
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Address
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Portsmouth Road
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City/town
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Frimley
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Zip/Postcode
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GU16 7UJ
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Country
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United Kingdom
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Sponsor website:
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http://www.frimleypark.nhs.uk/
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Date applied
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06/07/2008
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Last edited
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22/07/2008
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Date ISRCTN assigned
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22/07/2008
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