epafenac and prevention of cystoid macular edema (CME) after cataract surgery in patients receiving latanoprost
Completed
- Conditions
- Cystoid macular edema (CME)Eye DiseasesOedema
- Registration Number
- ISRCTN38025852
- Lead Sponsor
- Chulalongkorn University (Thailand)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Eyes receiving 0.005% Latanoprost at least 1-month prior to a planned phacoemulsification with PC-IOL implantation
2. Aged over 18 years, either sex
Exclusion Criteria
1. History of intra-ocular inflammation
2. Clinically significant macular edema (CSME), or macular oedema of any aetiology
3. Proliferative diabetic retinopathy
4. Retinitis pigmentosa
5. Prior vitreo-retinal surgery
6. Pregnancy
7. Known/suspicious allergy to non-steroidal anti-inflammatory drugs (NSAIDs)/prostaglandin analogues
8. 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 Difference in incidence of post-operative CME - detected with OCT and measured up to 10 weeks accumulatively - between either approaches: discontinuation of Latanoprost or continuing Latanoprost but with the administration of Nepafenac, compared with a group of patients who continue to use Latanoprost as previously used pre-operatively (control group or non-intervention group).
- Secondary Outcome Measures
Name Time Method Occurrence of post-cataract surgery CME in the non-intervention group (control group) detected by OCT.