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临床试验/NCT02088151
NCT02088151终止不适用

Selective Retinal Pigment Epithelium Laser Therapy (SRT) for Macular Disease of the Retina

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
18
试验地点
2
主要终点
Visual Acuity according to ETDRS protocol

研究概览

简要总结

Laser photocoagulation of the retina targeting the outer layers is an established therapy for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes. However, collateral damage occurs and scotomas can result when using conventional lasers with pulse duration of 100ms and more. This is particularly relevant for laser treatments of the macula where the main therapeutic effect results from stimulation of the retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent experimental research with new laser devices using much shorter pulse duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively targeted, hence the term selective retinal pigment epithelium laser therapy (SRT). Investigators hypothesize that SRT is equally effective as standard laser photocoagulation for macular disease but minimizes local visual field defects.

In this study, patients with central serous retinopathy, macular edema from diabetic microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration will be treated with SRT. Patients will be assessed 1, 3 and 6 months after treatment.

详细描述

Background

Laser photocoagulation of the retina targeting the outer layers is an established therapy for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes. However, collateral damage occurs and scotomas can result when using conventional lasers with pulse duration of 100ms and more. This is particularly relevant for laser treatments of the macula where the main therapeutic effect results from stimulation of the retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent experimental research with new laser devices using much shorter pulse duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively targeted, hence the term selective retinal pigment epithelium laser therapy (SRT). In age-related macular degeneration, regression of drusen has been observed after laser treatment with convention laser or SRT. Investigators hypothesize that SRT is equally effective as standard laser photocoagulation for macular disease but minimizes local visual field defects.

Objective

To assess the efficacy of SRT in patients with central serous retinopathy, macular edema from diabetic microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration. Up to five patients with proliferative diabetic retinopathy can optionally be treated with SRT too.

Methods

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age 18 or over
  • Written informed consent
  • Willingness to attend follow-up visits
  • Central serous chorioretinopathy affecting visual acuity
  • Macular edema from branch retinal vein occlusion
  • Macular edema from diabetic microangiopathy
  • Age-related macular degeneration with confluent soft drusen
  • Age-related macular degeneration with geographic atrophy
  • Exclusion Criteria
  • Macular ischemia
  • Retinal hemorrhage impeding retinal laser treatment
  • Subretinal neovascular membrane
  • Vitreous hemorrhage
  • Allergy to fluorescein
  • Participation in other clinical trials

排除标准

  • 未提供

结局指标

主要结局

Visual Acuity according to ETDRS protocol

时间窗: 6 months

次要结局

  • Leakage of fluorescein in fluorescein angiography(6 months)
  • Retinal thickness measured by optical coherence tomography(6 months)
  • Area of absent fundus autofluorescence(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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