Prophylactic Ketorolac Post Epiretinal Membrane Surgery

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974753
• Other study ID #: ERM-JG-2009
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: January 12, 2016
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2016
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Epiretinal Membrane
• Macular Edema

Intervention

Drug:
• Ketorolac 0.5%
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

Other:
• Saline drops
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

Locations

Country	Name	City	State
Canada	Department of Ophthalmology, Hotel Dieu Hospital, Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in macular volume from baseline.		Before surgery, at 1 week, 1 month, and 1 year after surgery.	No