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Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

NCT ID: NCT02412059

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Epiretinal Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Prednisolone

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

Group Type EXPERIMENTAL

Prednisolone acetate

Intervention Type DRUG

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prednisolone acetate

Intervention Type DRUG

Other Intervention Names

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Pred Forte

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myrna Lichter, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Toronto Department of Ophthalmology

References

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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.

Reference Type BACKGROUND
PMID: 25360790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7573306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18344963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24324293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3076143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3180837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8106541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23406256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6153251 (View on PubMed)

Other Identifiers

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LichterM

Identifier Type: -

Identifier Source: org_study_id