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Prophylactic Ketorolac Post Epiretinal Membrane Surgery

Primary Purpose

Macular Edema

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Ketorolac 0.5%

Saline drops

About this trial

This is an interventional prevention trial for Macular Edema focused on measuring epiretinal membrane

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

PPV-MP + Placebo (Saline drops)

PPV-MP + Ketorolac 0.5%

PhacoVit-MP + Placebo (Saline drops)

PhacoVit-MP + Ketorolac 0.5%.

Arm Description

PPV-MP= pars plana vitrectomy membrane peel

PhacoVit-MP= phacovitrectomy membrane peel

Outcomes

Primary Outcome Measures

Change in macular volume from baseline.

Secondary Outcome Measures

Full Information

NCT ID

NCT00974753

First Posted

September 8, 2009

Last Updated

January 12, 2016

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT00974753

Brief Title

Prophylactic Ketorolac Post Epiretinal Membrane Surgery

Official Title

A Placebo-controlled, Randomized, Clinical Trial of Prophylactic Ketorolac 0.5% in Patients Undergoing Pars Plana Vitrectomy and Phacovitrectomy Epiretinal Membrane Peel Surgery: Assessing Macular Volume With Spectral-domain OCT

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Queen's University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Edema

Keywords

epiretinal membrane

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PPV-MP + Placebo (Saline drops)

Arm Type

Placebo Comparator

Arm Description

PPV-MP= pars plana vitrectomy membrane peel

Arm Title

PPV-MP + Ketorolac 0.5%

Arm Type

Active Comparator

Arm Description

PPV-MP= pars plana vitrectomy membrane peel

Arm Title

PhacoVit-MP + Placebo (Saline drops)

Arm Type

Placebo Comparator

Arm Description

PhacoVit-MP= phacovitrectomy membrane peel

Arm Title

PhacoVit-MP + Ketorolac 0.5%.

Arm Type

Active Comparator

Arm Description

PhacoVit-MP= phacovitrectomy membrane peel

Intervention Type

Drug

Intervention Name(s)

Ketorolac 0.5%

Other Intervention Name(s)

ketorolac tromethamine, Apo-Ketorolac

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Saline drops

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in macular volume from baseline.

Time Frame

Before surgery, at 1 week, 1 month, and 1 year after surgery.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeff Gale, MD, FRCSC

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 3N6

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Prophylactic Ketorolac Post Epiretinal Membrane Surgery

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