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临床试验/NCT02894424
NCT02894424已完成不适用

Pilot Study of the Effect on the Retinal Sensitivity of the Membrane Blue Dual® Dye Used for Peeling of the Internal Limiting Membrane in Macular Hole Surgery

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
change in retinal sensitivity

研究概览

简要总结

The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years.

This hole causes an acute decline linked to a central scotoma. The only treatment is surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the tensile forces. To be sure the removed is complete and to facilitate the closure of the hole, a peeling of the internal limiting, the outermost layer of the retina, is often suggested. The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described. This sensitivity decrease could be induced by the dyes used during surgery.

This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher concentrations, at least on the isolated retina models.

It would be interesting to search for a decrease in retinal peri-foveal postoperative sensitivity after surgery of macular holes, performed with the usual dyes. Only microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive technique that explores the macular visual field. It is performed without iris dilatation and allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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 years
  • lower idiopathic macular hole inferior or equal to 600 micron millimeter
  • undergoing macular hole surgery

排除标准

  • Myopia > -3 diopters
  • pregnant women
  • no Health Insurance coverage
  • refusal to participate in the study

结局指标

主要结局

change in retinal sensitivity

时间窗: change from baseline sensitivity at 1 month after macular hole surgery

change from baseline sensitivity at 1 month after macular hole surgery

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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