A clinical trial to study the efficacy of Acular LS eyedrops in preventing thickening of the retina due to edema after cataract surgery. "Acular LS CME Study (ALCS)"
Phase 3
- Registration Number
- CTRI/2009/091/001078
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 704
Inclusion Criteria
Adult males and females 50-70 years of age coming for cataract surgery to our hospital.
Staying within 40 kms of Vellore town.
Exclusion Criteria
Inabiltity to visualise the macula preoperatively in the eye to be operated.
Ocular disease that can affect macular function.
Uncontrolled Diabetics defined by RBS/PP Sugars > 200mg/dl.
Diabetic Maculopathy with Edema in eye to be operated.
Past History of intraocular surgery in the eye under consideration.
History of use of Topical steroid drops or NSAID drops within the past 30 days prior to enrolment.
Current use of Oral steroids.
Known NSAIDs Allergy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute Pseudophakic Cystoid Macular EdemaTimepoint: 2 months
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI