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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00974753
Enrollment
18
Registered
2009-09-10
Start date
2010-03-31
Completion date
2012-03-31
Last updated
2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema

Keywords

epiretinal membrane

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.

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.

Sponsors

Queen's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in macular volume from baseline.Before surgery, at 1 week, 1 month, and 1 year after surgery.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026