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OpenTrials
Completed

NCT Number: NCT02412059

Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prednisolone Acetate

Drug

Other names: Pred Forte

Primary outcomes

  1. Incidence of epiretinal membrane

    Time frame: 6-months following administration of corticosteroid

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2015
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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