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.
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.
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Device: Spectacles |
| Control | No intervention | Workers 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.
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)
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
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
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
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
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
Attitudes towards vision correction
Worker's self-reported attitudes towards vision correction
Measured: At month 0
Access to local eyecare services
Worker's self-reported access to local eyecare services
Measured: At month 0
History of uptake of eyecare services
Worker's self-reported history of uptake of eyecare services
Measured: At month 0
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
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
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
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
Change in skill grade
Worker's skill grade as reported by supervisor.
Measured: Between baseline and endline at 18 months
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.
- First posted4 Dec 2020
- Study start21 May 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- VisionSpring, Clearly, University of Michigan, Good Business Lab, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Responsible party
- Principal investigator, Nathan Congdon, Queen's University, Belfast
- Investigators
- Nathan G Congdon, MD, MPH, Principal investigator, Queen's University, Belfast
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Near Vision Spectacle Correction on Work Retention Among Textile Factories Workers in India
- ClinicalTrials.gov ID
- NCT04654013
- Acronym / sponsor ID
- PROSPERIII / MHLS 20_84
- Conditions
- Presbyopia
- Keywords
- Presbyopia, Refractive error, Work retention, Spectacle wear compliance, Work efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,291 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- VisionSpring, Clearly, University of Michigan, Good Business Lab, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study start
- 21 May 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: SpectaclesWorkers 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. |
| Control | No intervention | –Workers assigned to the Control group will receive similar free glasses at the end of the study assessment (18 months). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpectaclesAlso: Eyeglasses, Reading glassesIntervention 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). | Device | Intervention |
Primary outcome
Work retention
Time frame: 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
14 secondary outcomes
Compliance with spectacle wear
Time frame: 3, 6, 9, 12, 15 and 18 months after enrolment
Change in work satisfaction
Time frame: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Change in feeling valued-at-work
Time frame: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Change in likeliness to stay at work
Time frame: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Change in work efficiency
Time frame: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Attitudes towards vision correction
Time frame: At month 0
Access to local eyecare services
Time frame: At month 0
History of uptake of eyecare services
Time frame: At month 0
Change in Quality of Life as assessed by the THRIVE Near Vision Quality of Life tool
Time frame: Between baseline and endline at 18 months
Reasons leaving employment at Shahi
Time frame: 2 months within participants leaving employment
Change in work productivity
Time frame: Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment
Cost effectiveness of intervention
Time frame: At study closeout at 18 months
Change in skill grade
Time frame: Between baseline and endline at 18 months
Change in monthly wage
Time frame: Between baseline and endline at 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan G Congdon, MD, MPH principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
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.