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Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery

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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01395069
Acronym
PNK
Enrollment
162
Registered
2011-07-15
Start date
2010-02-28
Completion date
2011-05-31
Last updated
2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema

Keywords

Post-cataract surgery, macular edema

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).

Interventions

1 drop QID for 1 month

1 drop QID for 1 month

OTHERPlacebo (sterile saline drops)

1 drop QID for 1 month

Sponsors

Queen's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in macular volume (as quantified by OCT) at one month (compared to baseline)baseline and one month after surgery

Secondary

MeasureTime frame
COMTOL health-related quality-of-lifeone month after surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026