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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00335439
Other study ID # QUEENS-SRE-2
Secondary ID
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


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
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