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临床试验/CTRI/2025/04/084351
CTRI/2025/04/084351招募中不适用

Randomised Controlled Trial of the Economic Advantages of Readers for Near vision in India

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2025年4月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Household Consumption and Vision Related Quality of Life

研究概览

简要总结

This is a prospective, single-masked, parallel group, two-arm individually randomised controlled trial (RCT), embedded within the community-based screening programme which is currently underway in Shahjahanpur and Lakhimpur Kheri districts, Uttar Pradesh, India. We aim to recruit adults between the ages 35 and 65 years, who have been identified as having presbyopia during screening, and do not own near vision glasses. Trial participants will be randomised to either the intervention arm - whereby individuals will be given free near vision glasses at the start of the study, or the control arm – whereby individuals will be given free near vision glasses at the end of the trial follow-up period (2 years). The co-primary outcomes are household consumption at 12 months and vision related quality of life at 12 months. Our secondary analysis will examine if the provision of near vision glasses to people of working age with presbyopia leads to: (i) increased individual income; (ii) increased household consumption, individual income, and/or workplace productivity in those who work in near vision intense/dependent occupations (occupational sub-group analysis). The findings will be written up for peer-reviewed publication and actively shared with key stakeholders. If the intervention proves effective it will inform policy and may catalyse funding to improve access to this relatively cheap and potentially cost-effective intervention.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • (1) Bilateral presbyopia and do not currently own or use glasses for near vision (2) Adults aged between 35 and 65 years (3) resident in the locality where the study is being conducted which means lived there for more than 6 months and intend to continue living there for the next two years (4) Provide informed consent and agreement to be randomly allocated to one of the two study arms.

排除标准

  • Presbyopia and owns near vision glasses (met need or partially met need)
  • Pinhole distance VA of worse than 6/12 in the better eye
  • Current illness or incapacity preventing the individual from working.
  • Inability to communicate.
  • Any occupation with formal guidance requiring safety glasses for near work.

结局指标

主要结局

Household Consumption and Vision Related Quality of Life

时间窗: at 12 months and 24 months

次要结局

  • Employment Status and characteristics(at 12 months and 24 months)
  • Self-reported productivity (presenteeism(at 12 months and 24 months)
  • Self-reported income sufficiency(at 12 months and 24 months)
  • Self-reported individual income (from employment and production)(at 12 months and 24 months)
  • Health related Quality of Life: EQ5D with vision bolt-on question(at 12 months and 24 months)

研究者

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

Dr Shalinder Sabherwal

Dr. Shroff Charity Eye Hospital

研究点 (1)

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