Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery (PNK)

Queen's University

Status and phase: Completed; Phase 4

Conditions: Macular Edema

Treatments: Other: Placebo (sterile saline drops); Drug: Nepafenac 0.1%; Drug: Ketorolac 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT01395069

PNK

Details and patient eligibility

About

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).

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 3 patient groups, including a placebo group

Nepafenac 0.1%

Active Comparator group

Treatment:

Drug: Nepafenac 0.1%

Ketorolac 0.5%

Active Comparator group

Treatment:

Drug: Ketorolac 0.5%

Placebo

Placebo Comparator group

Treatment:

Other: Placebo (sterile saline drops)