Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT02412059
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2015-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear
Sponsor:
Unity Health Toronto
Organization:
Study Overview
Official Title:
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Formation in Eyes With Retinal Tear Undergoing Laser Retinopexy: a Pilot Prospective Clinical Study
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: