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临床试验/CTRI/2025/05/087010
CTRI/2025/05/087010已完成不适用

A descriptive study to assess the Visual Acuity, vision related Quality of Life (QoL) and Patient Reported Outcome Measure (PROM) among patients with diabetic retinopathy with an intent to develop an audio care module.

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Visual Acuity

研究概览

简要总结

This descriptive study assessed visual acuity, vision-related Quality of Life (QoL), and Patient-Reported Outcome Measures (PROM) among patients with diabetic retinopathy to develop an audio care module. Data were collected in 200 participants using tools to evaluate visual acuity, QoL, and PROM, highlighting the functional and emotional impact of vision loss. The study revealed varying degrees of vision impairment, significantly affecting patients’ daily living, reading, and mobility. Participants reported challenges in physical and emotional well-being, emphasizing the burden of vision-related disabilities. Findings showed improvements in QoL over time in groups receiving interventions. The research underscores the need for comprehensive care that addresses clinical, functional, and psychological aspects of diabetic retinopathy. A tailored care module based on these findings could improve outcomes, enhance patient well-being, and support better disease management. This study highlights the value of integrating PROM and QoL assessments into routine care for diabetic retinopathy patients.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Type 2 Diabetic patients who attend Retina clinic, AIIMS Delhi.
  • Patients who consent to participate in the study.
  • Patients who can read and understand English and Hindi languages.

排除标准

  • Type 2 Diabetic patients with significant diabetic related complications, other than Diabetic Retinopathy (DR).
  • Type 2 diabetic patients with other ocular problems are excluded.

结局指标

主要结局

Visual Acuity

时间窗: Visual Acuity - at baseline | Vision related quality of life- at baseline | Patient Related Quality of Life- at baseline

Vision related quality of life

时间窗: Visual Acuity - at baseline | Vision related quality of life- at baseline | Patient Related Quality of Life- at baseline

Patient Related Quality of Life

时间窗: Visual Acuity - at baseline | Vision related quality of life- at baseline | Patient Related Quality of Life- at baseline

次要结局

  • Association between Diabetic Retinopathy and Visual Acuity.(Association between Diabetic Retinopathy and vision related quality of life.)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sonia Ravichandran CSR

All India Institute of Medical Sciences New Delhi

研究点 (1)

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