Prophylactic Ketorolac Post Epiretinal Membrane Surgery

Queen's University

Status: Completed

Conditions: Macular Edema

Treatments: Drug: Ketorolac 0.5%; Other: Saline drops

Study type: Interventional

Funder types: Other

Identifiers

NCT00974753

ERM-JG-2009

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 4 patient groups, including a placebo group

PPV-MP + Placebo (Saline drops)

Placebo Comparator group

Description:

PPV-MP= pars plana vitrectomy membrane peel

Treatment:

Other: Saline drops

PPV-MP + Ketorolac 0.5%

Active Comparator group

Description:

PPV-MP= pars plana vitrectomy membrane peel

Treatment:

Drug: Ketorolac 0.5%

PhacoVit-MP + Placebo (Saline drops)

Placebo Comparator group

Description:

PhacoVit-MP= phacovitrectomy membrane peel

Treatment:

Other: Saline drops

PhacoVit-MP + Ketorolac 0.5%.

Active Comparator group

Description:

PhacoVit-MP= phacovitrectomy membrane peel

Treatment:

Drug: Ketorolac 0.5%