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Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

U

Unity Health Toronto

Status

Completed

Conditions

Epiretinal Membrane

Treatments

Drug: Prednisolone acetate

Study type

Interventional

Funder types

Other

Identifiers

NCT02412059
LichterM

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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