AzTrials
AzTrials

PresbyopiaPROSPERIIINCT04654013

PROductivity Study of Presbyopia Elimination in Rural-dwellers III

A study testing Spectacles in people with Presbyopia, run by Queen's University, Belfast at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Presbyopia
What is being tested?
Spectacles
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,291 participants
Where
1 siteIndia
Study dates
21 May 2022to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Good Business Lab

    Bengaluru, Karantaka, 560102

Other trials in India

About this study

Official title: Effects of Near Vision Spectacle Correction on Work Retention Among Textile Factories Workers 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.

Read the detailed description

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.

Conditions
Presbyopia
Being tested
Spectacles
Keywords
Presbyopia, Refractive error, Work retention, Spectacle wear compliance, Work efficiency
Medical subject headings
Presbyopia, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpectaclesDevice

    Also called Eyeglasses, Reading glasses

    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).

Study groups in NCT04654013
Study groupRoleWhat they receive
InterventionExperimentalWorkers 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.
Receives: Device: Spectacles
ControlNo interventionWorkers assigned to the Control group will receive similar free glasses at the end of the study assessment (18 months).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Work retention

    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

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

Secondary outcomes (14)
  1. Compliance with spectacle wear

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

    Measured: 3, 6, 9, 12, 15 and 18 months after enrolment

  2. Change in work satisfaction

    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

    Measured: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

  3. Change in feeling valued-at-work

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

    Measured: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

  4. Change in likeliness to stay at work

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

    Measured: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

  5. Change in work efficiency

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

    Measured: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

  6. Attitudes towards vision correction

    Worker's self-reported attitudes towards vision correction

    Measured: At month 0

  7. Access to local eyecare services

    Worker's self-reported access to local eyecare services

    Measured: At month 0

  8. History of uptake of eyecare services

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

    Measured: At month 0

  9. Change in Quality of Life as assessed by the THRIVE Near Vision Quality of Life tool

    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).

    Measured: Between baseline and endline at 18 months

  10. Reasons leaving employment at Shahi

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

    Measured: 2 months within participants leaving employment

  11. Change in work productivity

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

    Measured: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

  12. Cost effectiveness of intervention

    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).

    Measured: At study closeout at 18 months

  13. Change in skill grade

    Worker's skill grade as reported by supervisor.

    Measured: Between baseline and endline at 18 months

  14. Change in monthly wage

    Worker's monthly wage as reported by supervisor.

    Measured: Between baseline and endline at 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2020
  2. Study start21 May 2022
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1260 workers aged 30 years and above with uncorrected presbyopia will be randomized to receive free glasses within one week of undergoing vision assessment, or free glasses at the end of the study assessment (18 months after vision assessment).
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04654013
Sponsor's protocol ID
MHLS 20_84
Acronym
PROSPERIII
Status last verified
Aug 2026
First submitted
21 Oct 2020
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Spectacles in people with Presbyopia, run by Queen's University, Belfast at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Work retention (time frame: September 2022 to May 2024; Over the 18 month follow-up period from enrolment to study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in