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농촌 거주자의 노안 제거에 대한 생산성 연구 III (PROSPERIII)

2026년 11월 3일 업데이트: Nathan Congdon, Queen's University, Belfast

근시 안경 교정이 인도 섬유 공장 근로자의 작업 유지에 미치는 영향

The investigators will conduct an embedded mixed methods study in which the primary approach is a randomized controlled trial (RCT), and the secondary or embedded approach is a descriptive qualitative study. The aim of the RCT is to assess the impact of presbyopic correction on workplace productivity and retention in the textile industry in a low middle-income country. Additional qualitative data will be collected to enhance understanding of factors linked to reasons why enrolled sew-ers left their job during the study. Participants will be textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Globally, 1.1 billion people lack a simple pair of reading glasses to correct impaired near vision, called presbyopia. Presbyopia can begin as early as age 30 years, commonly becomes functionally apparent by 40, and is essentially complete by 55 meaning that presbyopia is most common at the height of the working years. The global productivity loss due to uncorrected presbyopia has been estimated to exceed US$25 billion, and presbyopia is shown to be associated with significant impairment in activities of daily living. There is paucity in trial evidence of the impact on near vision spectacle correction on work productivity and workplace retention. The largest reported effect sizes among such trials (specifically for productivity) was the PROSPER trial, which showed that providing inexpensive near vision glasses increased the daily weight of tea picked among presbyopic, mostly-female Indian agricultural workers by more than 5 kg (21.7%) compared to those in the control group.

Study Plan: The investigators will choose 1260 textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India. They will be randomly assigned into one of two groups: a group receiving free reading glasses within one week of undergoing vision assessment ("Intervention") or a group receiving identical reading glasses at the end of the assessment period ("Control").The main study outcome will be the proportion of workers who continue working at the factories in the intervention group (as opposed to control). The investigators anticipate that the glasses intervention will increase retention by 20% in the Intervention group at 1 year.

The study will also assess the workers' efficiency, why they have left employment, how satisfied and valued they felt at their work and how often they use their glasses for work. These other outcomes will help the investigators to better understand the causal pathway between vision and work retention. The investigators will also study the total cost of providing glasses per additional worker retain their employment.

Research question: Will providing free glasses to presbyopic Indian textile workers increase work retention?

Design: Investigator-masked, multi-center randomized controlled trial with a qualitative component

Rationale: Although presbyopia is safely, effectively and inexpensively treated with glasses, rates of optical correction in LMICs are as low as 10%. The way in which firms manage workers has profound implications for performance by way of worker attendance, retention, and productivity. Similarly, worker engagement, and the extent to which workers feel valued, is a key determinant of firm performance. As the low-skill workforce in many developing countries transitions rapidly from agriculture to industrial work, employers struggle with high worker turnover due to poor working conditions, low pay, and restricted worker rights. Few trials have been published which address the question of whether healthcare interventions can improve work performance as well as workplace retention, especially among persons over the age of 40 in low and middle-income countries (LMICs). There is interest in understanding if these results obtained in an agricultural setting can be extended to other financially-important sectors.

Methods: The investigators will choose 1260 textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India. They will be randomly assigned into one of two groups: a group receiving free reading glasses within one week of undergoing vision assessment ("Intervention") or a group receiving identical reading glasses at the end of the assessment period ("Control").

The main outcome 18 month later will be work retention; secondary outcomes are workers' efficiency, the reasons the workers left their employment, satisfaction and perceived self-valued at work and glasses wear adherence at work. Attitudes about presbyopia and spectacle use and intervention cost-effectiveness will be studied.

연구 유형

중재적

등록 (실제)

1291

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Karantaka
      • Bengaluru, Karantaka, 인도, 560102
        • Good Business Lab

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

30년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Aged 30 years and above
  • Distance visual acuity >= 6/12 in both eyes
  • Presence of presbyopia, defined as the inability, correctable with reading glasses, to read the N8 line using both eyes together, on a tumbling near vision chart at a distance of 25cm, 30cm, 40cm, and 50cm based on workers working distance
  • Employed at the factory for >=3months in the sewing department

Exclusion Criteria:

  • Current ownership of reading or distance glasses (regardless of accuracy)
  • Obvious evidence of ocular disease in either eye detected during the eye examination, or history of such disease based on self-report
  • Low likelihood of completing follow-up in the study due to current plans to move out of the area or leave employment at Shahi during the follow-up period

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention

Workers assigned to the intervention group will receive free spectacles of a design they select, based on the worker's measured refractive power and dispensed one week later at the factory by the study ophthalmic personnel.

Intervention group workers receive free glasses within one week of undergoing vision assessment (May 2022). The duration of the treatment for the Intervention participants will depend on when they leave employment at the factor. If they stayed for the full duration of the trial, they will have undergone a maximum of 18 months (December 2023).

다른 이름들:
  • 안경
  • 돋보기 안경
간섭 없음: Control

Workers assigned to the Control group will receive similar free glasses at the end of the study assessment (18 months).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Work retention
기간: September 2022 to May 2024; Over the 18 month follow-up period from enrolment to study completion

Proportion of textile workers who continue to work at the textile factories assessed from trial entry to closure as recorded in Shahi's Human Resource Management Database

September 2022 to May 2024; Over the 18 month follow-up period from enrolment to study completion

2차 결과 측정

결과 측정
측정값 설명
기간
Compliance with spectacle wear
기간: 3, 6, 9, 12, 15 and 18 months after enrolment

Actual presence of spectacles on the worker's face at work as reported by supervisor at the time of unannounced observation

3, 6, 9, 12, 15 and 18 months after enrolment
Change in work satisfaction
기간: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

Proportion of sew-ers who state they are satisfied or very satisfied with work, feel valued or very valued at work, and are likely or very likely to stay with Shahi

Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Change in feeling valued-at-work
기간: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

Proportion of sew-ers who state they feel valued or very valued working at Shahi

Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Change in likeliness to stay at work
기간: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

Proportion of sew-ers who state they are likely or very likely to stay with Shahi

Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Change in work efficiency
기간: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

Self-assessed productivity scores using the Cantril's Ladder, with the best possible score being a 10, and the worst being a 0.

Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Attitudes towards vision correction
기간: At month 0

Worker's self-reported attitudes towards vision correction

At month 0
Access to local eyecare services
기간: At month 0

Worker's self-reported access to local eyecare services

At month 0
History of uptake of eyecare services
기간: At month 0

Worker's self-reported history of uptake of eyecare services

At month 0
Change in Quality of Life as assessed by the THRIVE Near Vision Quality of Life tool
기간: Between baseline and endline at 18 months

Self-reported quality of life scores measured with the modified THRIVE Near Vision Quality of Life tool, a Likert Scale ranging from 1 (least affected) to 5 (worst affected).

Between baseline and endline at 18 months
Reasons leaving employment at Shahi
기간: 2 months within participants leaving employment

Reasons given by the former supervisor and colleagues of former sew-ers for workers no longer being employed at Shahi

2 months within participants leaving employment
Change in work productivity
기간: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

Proportion of target production realized by a worker per unit time.

Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Cost effectiveness of intervention
기간: At study closeout at 18 months

Ratio of incremental program cost to additional workers in the intervention group who retain employment vs. those in the control group. Incremental cost is the difference of program costs between implementation of intervention and control (not including study costs, such as data collection).

At study closeout at 18 months
Change in skill grade
기간: Between baseline and endline at 18 months

Worker's skill grade as reported by supervisor.

Between baseline and endline at 18 months
Change in monthly wage
기간: Between baseline and endline at 18 months

Worker's monthly wage as reported by supervisor.

Between baseline and endline at 18 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Nathan G Congdon, MD, MPH, Queen's University, Belfast

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 5월 21일

기본 완료 (실제)

2024년 12월 30일

연구 완료 (실제)

2024년 12월 30일

연구 등록 날짜

최초 제출

2020년 10월 21일

QC 기준을 충족하는 최초 제출

2020년 12월 1일

처음 게시됨 (실제)

2020년 12월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 8월 1일

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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