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临床试验/NCT02412059
NCT02412059已完成不适用

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

Unity Health Toronto0 个研究点目标入组 200 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
200
主要终点
Incidence of epiretinal membrane

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between ages 18 to 80 (inclusive)
  • English-speaking
  • Undergoing non-pneumatic laser retinopexy procedure for horseshoe retinal tear (without retinal detachment)

排除标准

  • 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).

研究组 & 干预措施

Prednisolone

Experimental

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

干预措施: Prednisolone acetate (Drug)

结局指标

主要结局

Incidence of epiretinal membrane

时间窗: 6-months following administration of corticosteroid

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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