Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery

Queen's University162 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

162

Conditions

Macular Edema

Interventions

Nepafenac 0.1%DRUG

1 drop QID for 1 month

Ketorolac 0.5%DRUG

1 drop QID for 1 month

Placebo (sterile saline drops)OTHER

1 drop QID for 1 month

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hotel Dieu Hospital

Kingston, Ontario, Canada

Outcomes

Primary Outcomes

Change in macular volume (as quantified by OCT) at one month (compared to baseline)

Time frame: baseline and one month after surgery

Secondary Outcomes

COMTOL health-related quality-of-life

Time frame: one month after surgery

Data from ClinicalTrials.gov

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