Effect of Prophylactic Ketorolac on CME After Cataract Surgery

Macular Edema, Cystoid Clinical Trial

Official title:

Effect of Prophylactic NSAID Drops on Cystoid Macular Edema After Cataract Surgery Using Optical Coherence Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335439
• Other study ID #: QUEENS-SRE-2
• Status: Completed
• Phase: N/A
• First received: June 8, 2006
• Last updated: January 12, 2016
• Start date: June 2006
• Est. completion date: May 2007

Study information

• Verified date: January 2016
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• hypersensitivity to the NSAID drug class,

• pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Capsule Opacification
• Macular Edema
• Macular Edema, Cystoid

Intervention

Drug:
• ketorolac tromethamine 0.5% (Acular®)

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of cystoid macular edema by means of OCT (total macular volume) measurements