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

• Conditions: Post Small Incision Cataract Surgery (Pseudophakic) Acute Cystoid Macular Edema

• Registration Number: CTRI/2009/091/001078

Brief Summary

This study is a Randomised , triple blinded, parallel group, placebo controlled trial to assess the efficacy of Ketorolac Tromethamine 0.4% eye drops (1 drop 4 times a day for 2 months) in prophylactically preventing Acute Pseudophakic Cystoid Macular Edema as compared to a placebo. The study will be conducted at 1 site only in the Department of Ophthalmology of a Tertiary care level hospital and will randomise 704 patients to the two protocols (352 in each arm). The primary outcome will be occurrence of Cystoid Macular Edema in post cataract surgery patients measured clinically with visual acuity and fundus examination with Slit Lamp Biomicroscopy and also with Optical Coherence Tomography (Fast Macula scan)

Detailed Description

Not available

Recruitment & Eligibility

• 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: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Pseudophakic Cystoid Macular Edema	2 months

Trial Locations

Locations (1)

Department of Ophthalmolog; 🇮🇳 Vellore, TAMIL NADU, India

Department of Ophthalmolog

🇮🇳Vellore, TAMIL NADU, India

Dr. Abhishek Hoshing

Principal investigator

ahoshing@gmail.com