Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery

Phase 4

Completed

• Conditions: Macular Edema
• Interventions: Drug: Ketorolac 0.5%; Drug: Nepafenac 0.1%; Other: Placebo (sterile saline drops)

• Registration Number: NCT01395069
• Lead Sponsor: Queen's University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-15
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac 0.5%	Ketorolac 0.5%	-
Nepafenac 0.1%	Nepafenac 0.1%	-
Placebo	Placebo (sterile saline drops)	-

Primary Outcome Measures

Name	Time	Method
Change in macular volume (as quantified by OCT) at one month (compared to baseline)	baseline and one month after surgery

Secondary Outcome Measures

Name	Time	Method
COMTOL health-related quality-of-life	one month after surgery

Trial Locations

Locations (1)

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada