Prophylactic Ketorolac Post Epiretinal Membrane Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: Ketorolac 0.5%
* Other: Saline drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PPV-MP + Placebo (Saline drops)<br>PPV-MP= pars plana vitrectomy membrane peel | Other: Saline drops<br>* Four-times a day starting one week before surgery and continued for 4 weeks post surgery.<br>|
| Active Comparator: PPV-MP + Ketorolac 0.5%<br>PPV-MP= pars plana vitrectomy membrane peel | Drug: Ketorolac 0.5%<br>* Four-times a day starting one week before surgery and continued for 4 weeks post surgery.<br>* Other names: Apo-Ketorolac;|
| Placebo Comparator: PhacoVit-MP + Placebo (Saline drops)<br>PhacoVit-MP= phacovitrectomy membrane peel | Other: Saline drops<br>* Four-times a day starting one week before surgery and continued for 4 weeks post surgery.<br>|
| Active Comparator: PhacoVit-MP + Ketorolac 0.5%.<br>PhacoVit-MP= phacovitrectomy membrane peel | Drug: Ketorolac 0.5%<br>* Four-times a day starting one week before surgery and continued for 4 weeks post surgery.<br>* Other names: Apo-Ketorolac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in macular volume from baseline. |  | Before surgery, at 1 week, 1 month, and 1 year after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epiretinal membrane