Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

Sponsor

Unity Health Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02412059

Collaborator

University of Toronto (Other)

200

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane	Drug: Prednisolone acetate	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prednisolone Pred Forte (prednisolone acetate ophthalmic suspension, USP) 1% sterile	Drug: Prednisolone acetate Other Names: Pred Forte
No Intervention: Control Patients in control group will not be given a corticosteroid as per usual standard of care.

Arm

Intervention/Treatment

Experimental: Prednisolone

Pred Forte (prednisolone acetate ophthalmic suspension, USP) 1% sterile

Drug: Prednisolone acetate

Other Names:

Pred Forte

No Intervention: Control

Patients in control group will not be given a corticosteroid as per usual standard of care.

Outcome Measures

Primary Outcome Measures

Incidence of epiretinal membrane [6-months following administration of corticosteroid]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).