NCT00335439

Brief Summary

The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

June 8, 2006

Last Update Submit

January 12, 2016

Conditions

Macular Edema, Cystoid

Outcome Measures

Primary Outcomes (1)

  • Degree of cystoid macular edema by means of OCT (total macular volume) measurements

Interventions

ketorolac tromethamine 0.5% (Acular®)DRUG

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First cataract surgery (i.e., first eye).

You may not qualify if:

  • hypersensitivity to the NSAID drug class,
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sherif El-Defrawy, MD PhD FRCSC

    Hotel Dieu Hospital, Kingston General Hospital, Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 9, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

CA(1)