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)"

Randomised , triple blinded, placebo controlled, clinical trial to compare the effect of Ketorolac tromethamine 0.4% in prophylactically preventing Cystoid Macula Edema following Cataract Surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001078

Enrollment

704

Registered

2010-03-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Ketorolac tromethamine eye drops 0.4%: one drop 4 times in a day for 2 months Control Intervention1: Polyvinyl Alcohol 14mg/ml (Tear Substitute): One drop 4 times a day for 2 months

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Acute Pseudophakic Cystoid Macular EdemaTimepoint: 2 months	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr. Abhishek Hoshing

pushpa_jacob@hotmail.com0416-2281201

Outcome results