Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

Not Applicable

Completed

• Conditions: Epiretinal Membrane
• Interventions: Drug: Prednisolone acetate

• Registration Number: NCT02412059
• Lead Sponsor: Unity Health Toronto

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-03
• Study First Posted: 2015-04-08
• Study Start: 2015-08
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone	Prednisolone acetate	Pred Forte (prednisolone acetate ophthalmic suspension, USP) 1% sterile

Primary Outcome Measures

Name	Time	Method
Incidence of epiretinal membrane	6-months following administration of corticosteroid