Effect of Prophylactic Ketorolac on CME After Cataract Surgery

NCT ID: NCT00335439

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-05-31

Brief Summary

The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.

Conditions

Macular Edema, Cystoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

ketorolac tromethamine 0.5% (Acular®)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• First cataract surgery (i.e., first eye).

Exclusion Criteria

• hypersensitivity to the NSAID drug class,
• pregnancy.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sherif R El-Defrawy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherif El-Defrawy, MD PhD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu Hospital, Kingston General Hospital, Queen's University

Locations

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

QUEENS-SRE-2

Identifier Type: -

Identifier Source: org_study_id