Prophylactic Ketorolac Post Epiretinal Membrane Surgery
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
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2010
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
September 8, 2009
CompletedFirst Posted
Study publicly available on registry
September 10, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJanuary 13, 2016
January 1, 2016
2 years
September 8, 2009
January 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in macular volume from baseline.
Before surgery, at 1 week, 1 month, and 1 year after surgery.
Study Arms (4)
PPV-MP + Placebo (Saline drops)
PLACEBO COMPARATORPPV-MP= pars plana vitrectomy membrane peel
PPV-MP + Ketorolac 0.5%
ACTIVE COMPARATORPPV-MP= pars plana vitrectomy membrane peel
PhacoVit-MP + Placebo (Saline drops)
PLACEBO COMPARATORPhacoVit-MP= phacovitrectomy membrane peel
PhacoVit-MP + Ketorolac 0.5%.
ACTIVE COMPARATORPhacoVit-MP= phacovitrectomy membrane peel
Interventions
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
Eligibility Criteria
You may qualify if:
- idiopathic epiretinal membrane diagnosis requiring membrane peel surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology, Hotel Dieu Hospital, Queen's University
Kingston, Ontario, K7L 3N6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Gale, MD, FRCSC
Queen's University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2009
First Posted
September 10, 2009
Study Start
March 1, 2010
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
January 13, 2016
Record last verified: 2016-01