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临床试验/NCT07331870
NCT07331870已完成不适用

Performance Evaluation of DIY Digital Visual Acuity Test

Ojenforeningen1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Agreement of Digital Visual Acuity Test Scores With ETDRS (Distance) and Radner (Near) Visual Acuity Scores

研究概览

简要总结

This study aims to verify the accuracy of a new Digital Visual Acuity test. The test results obtained with the support of the device will be compared to the current standard of care related to visual acuity testing.

详细描述

The investigational device is a software-based application for computers and tablets that enables individuals without professional training to self-assess their near and distance visual acuity. It is a low-risk device and represents an evolution of an already marketed product. The device is intended to support ongoing monitoring for patients with conditions that may affect visual acuity, helping track changes over time. It is not designed to replace a comprehensive eye examination performed by a qualified eye-care professional. For this study, the advanced version of the application will be used.

The study population will include adults with normal, subnormal, and low vision to ensure validation of the test across the full range of visual acuity levels. Participants will include patients attending the Eye Department for treatment of various ocular conditions (low-vision group), as well as patients' spouses and department staff (subnormal and normal vision groups). All participants must be able to make independent judgments. Before participation, each individual will receive information about the study procedures, including the nature of the intervention and their right to withdraw at any time.

The device does not require specialized training. Users will receive a brief initial orientation on how to operate the application. For the home self-test, users will complete the assessment independently and without assistance to evaluate the device's usability and support autonomous testing.

研究设计

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

盲法说明

No making applied

入排标准

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

入选标准

  • •18 years of age and older.
  • •Subjects must be able to understand and perform the test.
  • •Subject must have corrected vison (i.e. wearing glasses)

排除标准

  • •Subjects not able to understand the implications of participating in a scientific study.
  • •Subjects not legally independent.
  • •Subjects not able to perform the test.

研究组 & 干预措施

Comparaison to standard of Care

Experimental

The measurements performed with the investigational device are compared to the standard of care (ETDRS and Radner test)

干预措施: Comparaison of the investigation device measurement with standard of Care (Device)

结局指标

主要结局

Agreement of Digital Visual Acuity Test Scores With ETDRS (Distance) and Radner (Near) Visual Acuity Scores

时间窗: up to 90 days

Difference and agreement between visual acuity scores obtained using the DIY Digital Visual Acuity Test and scores obtained using the ETDRS chart for distance vision and the Radner chart for near vision, measured in logMAR units.

Repeatability of Visual Acuity Measurements Obtained With the DIY Digital Visual Acuity Test Compared With ETDRS (Distance) and Radner (Near) Charts

时间窗: up to 90 days

Within-subject repeatability of visual acuity measurements, expressed in logMAR units, across repeated use of the DIY Digital Visual Acuity Test compared with repeated measurements obtained using ETDRS charts for distance vision and Radner charts for near vision.

次要结局

未报告次要终点

研究者

发起方
Ojenforeningen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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