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NCT01395069 Clinical Trial

Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery

Macular Edema Clinical Trial

— PNK  

Official title:
Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01395069
Other study ID # PNK
Secondary ID
Status Completed
Phase Phase 4
First received July 11, 2011
Last updated January 12, 2016
Start date February 2010
Est. completion date May 2011

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

Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).

Recruitment information / eligibility
Status Completed
Enrollment 162
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ability to give informed consent

- Age 18 years and older

Exclusion Criteria:

- Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.)

- Previous uveitis

- Previous intraocular surgery

- Allergy or hypersensitivity to NSAIDs

- Complicated cataract surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Nepafenac 0.1%
1 drop QID for 1 month
• Ketorolac 0.5%
1 drop QID for 1 month
Other:
• Placebo (sterile saline drops)
1 drop QID for 1 month

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 Change in macular volume (as quantified by OCT) at one month (compared to baseline) baseline and one month after surgery No
Secondary COMTOL health-related quality-of-life one month after surgery No
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