Prophylactic Ketorolac Post Epiretinal Membrane Surgery

NCT ID: NCT00974753

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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Evaluate the efficacy of ketorolac 0.5%, a topical non-steroidal anti-inflammatory drug (NSAID), to prevent macular edema after epiretinal membrane surgery. Patients undergoing epiretinal membrane surgery have increased risk of macular swelling which can adversely affect vision. Since post-intraocular surgery inflammation is a contributing factor to macular swelling and loss of vision, NSAID drops may be able to prevent or minimize the deleterious effects of macular swelling after epiretinal membrane surgery.

Detailed Description

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Conditions

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Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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PPV-MP + Placebo (Saline drops)

PPV-MP= pars plana vitrectomy membrane peel

Group Type PLACEBO_COMPARATOR

Saline drops

Intervention Type OTHER

Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

PPV-MP + Ketorolac 0.5%

PPV-MP= pars plana vitrectomy membrane peel

Group Type ACTIVE_COMPARATOR

Ketorolac 0.5%

Intervention Type DRUG

Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

PhacoVit-MP + Placebo (Saline drops)

PhacoVit-MP= phacovitrectomy membrane peel

Group Type PLACEBO_COMPARATOR

Saline drops

Intervention Type OTHER

Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

PhacoVit-MP + Ketorolac 0.5%.

PhacoVit-MP= phacovitrectomy membrane peel

Group Type ACTIVE_COMPARATOR

Ketorolac 0.5%

Intervention Type DRUG

Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

Interventions

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Ketorolac 0.5%

Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

Intervention Type DRUG

Saline drops

Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

Intervention Type OTHER

Other Intervention Names

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ketorolac tromethamine Apo-Ketorolac

Eligibility Criteria

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Inclusion Criteria

* idiopathic epiretinal membrane diagnosis requiring membrane peel surgery

Exclusion Criteria

* proliferative diabetic retinopathy
* sickle cell retinopathy
* radiation retinopathy
* choroidal folds
* hypersensitivity or allergy to NSAIDs
* wet macular degeneration
* branch retinal vein occlusion (BRVO)
* central retinal vein occlusion (CRVO)
* complicated membrane peel surgery
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff Gale, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Department of Ophthalmology, Hotel Dieu Hospital, Queen's University

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ERM-JG-2009

Identifier Type: -

Identifier Source: org_study_id

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