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OpenTrials
Completed

NCT Number: NCT01395069

Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery

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).

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Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu Hospital

Kingston, Ontario, K7L 3G2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: baseline and one month after surgery

Secondary outcomes

  1. COMTOL health-related quality-of-life

    Time frame: one month after surgery

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study 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)

Acronym: PNK

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 15, 2011
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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