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PROduttività Studio dell'eliminazione della presbiopia negli abitanti delle zone rurali III (PROSPERIII)

3 novembre 2026 aggiornato da: Nathan Congdon, Queen's University, Belfast

Effetti della correzione degli occhiali per la visione da vicino sulla conservazione del lavoro tra i lavoratori delle fabbriche tessili in India

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1291

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

30 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).

Altri nomi:
  • Occhiali
  • Occhiali da lettura
Nessun intervento: Control

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Work retention
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Compliance with spectacle wear
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At month 0

Worker's self-reported attitudes towards vision correction

At month 0
Access to local eyecare services
Lasso di tempo: At month 0

Worker's self-reported access to local eyecare services

At month 0
History of uptake of eyecare services
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Between baseline and endline at 18 months

Worker's monthly wage as reported by supervisor.

Between baseline and endline at 18 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Nathan G Congdon, MD, MPH, Queen's University, Belfast

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 maggio 2022

Completamento primario (Effettivo)

30 dicembre 2024

Completamento dello studio (Effettivo)

30 dicembre 2024

Date di iscrizione allo studio

Primo inviato

21 ottobre 2020

Primo inviato che soddisfa i criteri di controllo qualità

1 dicembre 2020

Primo Inserito (Effettivo)

4 dicembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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