NCT01395069

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

July 11, 2011

Last Update Submit

January 12, 2016

Conditions

Macular Edema

Keywords

Post-cataract surgerymacular edema

Outcome Measures

Primary Outcomes (1)

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

    baseline and one month after surgery

Secondary Outcomes (1)

  • COMTOL health-related quality-of-life

    one month after surgery

Study Arms (3)

Nepafenac 0.1%

ACTIVE COMPARATOR
Drug: Nepafenac 0.1%

Ketorolac 0.5%

ACTIVE COMPARATOR
Drug: Ketorolac 0.5%

Placebo

PLACEBO COMPARATOR
Other: Placebo (sterile saline drops)

Interventions

Nepafenac 0.1%DRUG

1 drop QID for 1 month

Nepafenac 0.1%
Ketorolac 0.5%DRUG

1 drop QID for 1 month

Ketorolac 0.5%
Placebo (sterile saline drops)OTHER

1 drop QID for 1 month

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to give informed consent
  • Age 18 years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 3G2, Canada

Location

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Sherif El-Defrawy, MD PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 15, 2011

Study Start

February 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

CA(1)