search
Back to results

Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

Primary Purpose

Epiretinal Membrane

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prednisolone acetate
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epiretinal Membrane

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Prednisolone

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Incidence of epiretinal membrane

    Secondary Outcome Measures

    Full Information

    First Posted
    April 3, 2015
    Last Updated
    January 28, 2016
    Sponsor
    Unity Health Toronto
    Collaborators
    University of Toronto
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02412059
    Brief Title
    Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Unity Health Toronto
    Collaborators
    University of Toronto

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epiretinal Membrane

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Prednisolone
    Arm Type
    Experimental
    Arm Description
    Pred Forte (prednisolone acetate ophthalmic suspension, USP) 1% sterile
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients in control group will not be given a corticosteroid as per usual standard of care.
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone acetate
    Other Intervention Name(s)
    Pred Forte
    Primary Outcome Measure Information:
    Title
    Incidence of epiretinal membrane
    Time Frame
    6-months following administration of corticosteroid

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Myrna Lichter, MD, FRCSC
    Organizational Affiliation
    University of Toronto Department of Ophthalmology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25360790
    Citation
    Bu SC, Kuijer R, Li XR, Hooymans JM, Los LI. Idiopathic epiretinal membrane. Retina. 2014 Dec;34(12):2317-35. doi: 10.1097/IAE.0000000000000349.
    Results Reference
    background
    PubMed Identifier
    7573306
    Citation
    Saran BR, Brucker AJ. Macular epiretinal membrane formation and treated retinal breaks. Am J Ophthalmol. 1995 Oct;120(4):480-5. doi: 10.1016/s0002-9394(14)72662-5. Erratum In: Am J Ophthalmol 1996 Mar;121(3):334.
    Results Reference
    background
    PubMed Identifier
    18344963
    Citation
    Snead DR, James S, Snead MP. Pathological changes in the vitreoretinal junction 1: epiretinal membrane formation. Eye (Lond). 2008 Oct;22(10):1310-7. doi: 10.1038/eye.2008.36. Epub 2008 Mar 14.
    Results Reference
    background
    PubMed Identifier
    24324293
    Citation
    Joshi M, Agrawal S, Christoforidis JB. Inflammatory mechanisms of idiopathic epiretinal membrane formation. Mediators Inflamm. 2013;2013:192582. doi: 10.1155/2013/192582. Epub 2013 Nov 11.
    Results Reference
    background
    PubMed Identifier
    3076143
    Citation
    Gilbert C, Hiscott P, Unger W, Grierson I, McLeod D. Inflammation and the formation of epiretinal membranes. Eye (Lond). 1988;2 Suppl:S140-56. doi: 10.1038/eye.1988.140.
    Results Reference
    background
    PubMed Identifier
    3180837
    Citation
    Hiscott PS, Unger WG, Grierson I, McLeod D. The role of inflammation in the development of epiretinal membranes. Curr Eye Res. 1988 Sep;7(9):877-92. doi: 10.3109/02713688808997245.
    Results Reference
    background
    PubMed Identifier
    8106541
    Citation
    Grinnell F. Fibroblasts, myofibroblasts, and wound contraction. J Cell Biol. 1994 Feb;124(4):401-4. doi: 10.1083/jcb.124.4.401. No abstract available.
    Results Reference
    background
    PubMed Identifier
    23406256
    Citation
    Banerjee PJ, Woodcock MG, Bunce C, Scott R, Charteris DG. A pilot study of intraocular use of intensive anti-inflammatory; triamcinolone acetonide to prevent proliferative vitreoretinopathy in eyes undergoing vitreoretinal surgery for open globe trauma; the Adjuncts in Ocular Trauma (AOT) Trial: study protocol for a randomised controlled trial. Trials. 2013 Feb 13;14:42. doi: 10.1186/1745-6215-14-42.
    Results Reference
    background
    PubMed Identifier
    6153251
    Citation
    Tano Y, Sugita G, Abrams G, Machemer R. Inhibition of intraocular proliferations with intravitreal corticosteroids. Am J Ophthalmol. 1980 Jan;89(1):131-6. doi: 10.1016/0002-9394(80)90239-1.
    Results Reference
    background

    Learn more about this trial

    Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

    We'll reach out to this number within 24 hrs