Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

Study Overview
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Brief Summary
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In this prospective randomized controlled double blind pilot clinical study, we aim to assess whether administration of a topical corticosteroid would attenuate epiretinal membrane formation following development of retinal tears treated with laser retionpexy.

Detailed Description
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Epiretinal membrane (ERM) is a frequent, sight-threatening eye condition occurring in 1.02% - 28.9% of eyes in persons aged 40 years or older. [1] While often idiopathic in nature, ERM formation has been associated with retinal tears, possibly due to a breakdown of the blood-retinal barrier [1-3]. Pathological analysis of ERM content shows inflammatory mediators such as cytokines, growth factors and interleukins, which can promote fibroblast remodelling that leads to a contractile scar formation on the retinal surface. [1, 4-8] For this reason, ERM formation has been suggested to be an aberrant tissue repair or wound-healing process driven by inflammatory reactions. Since corticosteroids inhibit the inflammatory cascade and fibroblast transdifferentiation, administration of a corticosteroid following retinal tears should theoretically reduce the risk of ERM formation. [9-10] In this study, we aim to assess whether administration of a topical corticosteroid would attenuate ERM formation following laser retinopexy of retinal tears.

Official Title
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Topical Use of Corticosteroid to Prevent Epiretinal Membrane Formation in Eyes With Retinal Tear Undergoing Laser Retinopexy: a Pilot Prospective Clinical Study

Conditions
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Epiretinal Membrane

Intervention / Treatment
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* Drug: Prednisolone acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between ages 18 to 80 (inclusive) English-speaking Undergoing non-pneumatic laser retinopexy procedure for horseshoe retinal tear (without retinal detachment) Exclusion Criteria: Patient refusal or delay of retinopexy procedure for more than 48 hours after diagnosis Patients who are pseudophakic or aphakic Medical conditions contraindicated with prednisolone: viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fundal diseases of ocular structures; mycobacterial infections; hypercortisolism. Previous history of epiretinal membrane, retinal surgery (cryo or laser) Patients with hypersensitivity or contraindication for corticosteroids (viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fungal diseases of ocular structures; mycobacterial infections; hypercortisolism).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisolone<br>Pred Forte (prednisolone acetate ophthalmic suspension, USP) 1% sterile | Drug: Prednisolone acetate<br> <br> * Other names: Pred Forte;|
| No Intervention: Control<br>Patients in control group will not be given a corticosteroid as per usual standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of epiretinal membrane |  | 6-months following administration of corticosteroid |