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临床试验/NCT05829135
NCT05829135撤回不适用

Managing Visual Comfort and Function in Patients With Low Vision Using Acuvue Oasys

Nova Southeastern University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
16
试验地点
2
主要终点
Glare test

研究概览

简要总结

To assess the use of contact lenses with transitions technology to improve glare, light sensitivity and overall visual comfort in patients with visual impairment.

详细描述

Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology can adapt to the amount of visible light in the environment, darkening the lenses in bright sunlight, and returning to regular tint in normal or dim environment.

Purpose of this study is to assess whether individuals with visual impairment may benefit from these lenses to minimize glare, light sensitivity symptoms and improve the overall visual comfort.

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 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to give informed consent
  • Able to speak and read English
  • Experience glare and light sensitivity that impacts patient's daily living activities
  • Have confirmed diagnosis of ocular condition including but not limited to Stargardt's, Cone dystrophy, Cone-rod dystrophy, Albinism, Retinitis Pigmentosa and Achromatopsia.
  • Willing and able to wear the contact lenses as instructed

排除标准

  • Are pregnant, nursing or planning to become pregnant during the course of the study
  • Have current/recent ocular infection, inflammation, surgery in the past 3 months that contraindicates contact lens wear

结局指标

主要结局

Glare test

时间窗: Measure change from baseline at the 6 week follow-up visit

Measure visual acuity and contrast sensitivity with or without illumination source

次要结局

  • Visual Activities Questionnaire on Glare and Light sensitivity visual functions(Measure change from baseline at the 6 week follow-up visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

So Yeon Lee

Assistant professor

Nova Southeastern University

研究点 (2)

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