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Prevention of post-cataract surgery macula oedema with prophylactic ketorolac

Prevention of pseudophakic cystoid macula oedema with pre- and post-operative ketorolac

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN02628492
Enrollment
1400
Registered
2008-07-22
Start date
2008-07-12
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystoid macular oedema (CMO) Eye Diseases Other retinal disorders

Interventions

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

Sponsors

Frimley Park Hospital NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously had a reaction to ketorolac 2. Patients who are on systemic non-steroidal anti-inflammatories or steroids

Design outcomes

Primary

MeasureTime frame
Central macula thickness as measured on optical coherence tomography at baseline (prior to surgery), 1 month after surgery, 2 months after surgery and 3 months after surgery.

Secondary

MeasureTime frame
1. Logarithmic minimal angle of resolution (LogMAR) visual acuity 2. Contrast sensitivity 3. Adverse events The secondary outcomes will be measured at baseline (prior to surgery), 1 month after surgery, 2 months after surgery and 3 months after surgery.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026