epafenac and Prevention of CME after Cataract Surgery in Patients Receiving Latanoprost: A Randomized Controlled Trial
Phase 3
Recruiting
- Conditions
- Cystoid macular oedemaCMEProstaglandinLatanoprostNepafenacNSAIDsCataract surgeryPhacoemulsificationOCTOptical coherence tomography
- Registration Number
- TCTR20110000013
- Lead Sponsor
- Glaucoma Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Eyes receiving 0.005% Latanoprost at least 1-month prior to a planned phacoemulsification with PC-IOL implantation; age over 18 years
Exclusion Criteria
history of intra-ocular inflammation; CSME, or macular oedema of any aetiology; proliferative
diabetic retinopathy; retinitis pigmentosa; prior vitreo-retinal surgery; pregnancy;
known/suspicious allergy to NSAIDs/Prostaglandin analogues; physical/mental/intellectual
disabilities preventing from understanding and complying to protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of post-operative CME Up to 10 weeks accumulatively post-operative Optical Coherence Tomography
- Secondary Outcome Measures
Name Time Method Occurrence of post-cataract surgery CME in non-intervention group Up to 10 weeks accumulatively post-operative Optical Coherence Tomography