Back to resultsEffect of Prophylactic Ketorolac on CME After Cataract Surgery
Primary Purpose
Macular Edema, Cystoid
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ketorolac tromethamine 0.5% (Acular®)
Sponsored by
About this trial
This is an interventional prevention trial for Macular Edema, Cystoid
Eligibility Criteria
Inclusion Criteria: First cataract surgery (i.e., first eye). Exclusion Criteria: hypersensitivity to the NSAID drug class, pregnancy.
Sites / Locations
- Hotel Dieu Hospital
Outcomes
Primary Outcome Measures
Degree of cystoid macular edema by means of OCT (total macular volume) measurements
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00335439
Brief Title
Effect of Prophylactic Ketorolac on CME After Cataract Surgery
Official Title
Effect of Prophylactic NSAID Drops on Cystoid Macular Edema After Cataract Surgery Using Optical Coherence Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Cystoid
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ketorolac tromethamine 0.5% (Acular®)
Primary Outcome Measure Information:
Title
Degree of cystoid macular edema by means of OCT (total macular volume) measurements
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
First cataract surgery (i.e., first eye).
Exclusion Criteria:
hypersensitivity to the NSAID drug class,
pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif El-Defrawy, MD PhD FRCSC
Organizational Affiliation
Hotel Dieu Hospital, Kingston General Hospital, Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effect of Prophylactic Ketorolac on CME After Cataract Surgery
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