Topical Use of Corticosteroid to Prevent Epiretinal Membrane Formation in Eyes With Retinal Tear Undergoing Laser Retinopexy: a Pilot Prospective Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Prednisolone acetate
- Conditions
- Epiretinal Membrane
- Sponsor
- Unity Health Toronto
- Enrollment
- 200
- Primary Endpoint
- Incidence of epiretinal membrane
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
Prednisolone
Pred Forte (prednisolone acetate ophthalmic suspension, USP) 1% sterile
Intervention: Prednisolone acetate
Outcomes
Primary Outcomes
Incidence of epiretinal membrane
Time Frame: 6-months following administration of corticosteroid