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临床试验/NCT04693702
NCT04693702已完成不适用

Observational Study of Vision Improvement in Patients With Retinal Disorders

Optimal Acuity Corporation1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年10月1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
54
试验地点
1
主要终点
CDVA

研究概览

简要总结

The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.

详细描述

The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

研究设计

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

入排标准

年龄范围
50 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Female or male
  • Patient is at least 50 years old
  • Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes
  • Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract
  • Patient had moderate to severe baseline vision impairment with CDVA of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s)
  • Patient CDVA records are available at baseline and at 1m or longer post-Tx times

排除标准

  • 1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm Hg), glaucoma or history of glaucoma 3 - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study

结局指标

主要结局

CDVA

时间窗: 12 months

Best spectacle-corrected distance visual acuity

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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