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

Primary Purpose

Macular Edema

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Nepafenac 0.1%
Ketorolac 0.5%
Placebo (sterile saline drops)
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Macular Edema focused on measuring Post-cataract surgery, macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Nepafenac 0.1%

Ketorolac 0.5%

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

COMTOL health-related quality-of-life

Full Information

First Posted
July 11, 2011
Last Updated
January 12, 2016
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT01395069
Brief Title
Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery
Acronym
PNK
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
Keywords
Post-cataract surgery, macular edema

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nepafenac 0.1%
Arm Type
Active Comparator
Arm Title
Ketorolac 0.5%
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nepafenac 0.1%
Intervention Description
1 drop QID for 1 month
Intervention Type
Drug
Intervention Name(s)
Ketorolac 0.5%
Intervention Description
1 drop QID for 1 month
Intervention Type
Other
Intervention Name(s)
Placebo (sterile saline drops)
Intervention Description
1 drop QID for 1 month
Primary Outcome Measure Information:
Title
Change in macular volume (as quantified by OCT) at one month (compared to baseline)
Time Frame
baseline and one month after surgery
Secondary Outcome Measure Information:
Title
COMTOL health-related quality-of-life
Time Frame
one month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif El-Defrawy, MD PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3G2
Country
Canada

12. IPD Sharing Statement

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Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery

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