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| Name | Class |
|---|---|
| VisionSpring | OTHER |
| University of Michigan | OTHER |
| Good Business Lab | UNKNOWN |
| Zhongshan Ophthalmic Center, Sun Yat-sen University |
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The investigators will conduct a randomized-controlled trial. The participants will be textile workers aged 35 years and above with uncorrected presbyopia who are employed by a single Indian garment manufacturer - employed by Shahi Exports Private Limited, Karnataka, India - at facilities equipped to measure individual productivity. PROSPER II will assess the impact of free reading glasses on productivity for workers in a textile factory.
Globally, 3 billion people do not have the eyeglasses they need to earn, learn, travel safely in traffic and participate in civic life. Among these, 1.1 billion people lack a simple pair of reading glasses to correct impaired near vision, called presbyopia. Presbyopia, the essentially universal decline in unaided near vision that occurs with aging, is the world's most common cause of vision impairment. Loss of accommodation (ability to change focus from distance to near) due to 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.
Study Plan: This is a randomized trial designed to assess the impact of free spectacles on workplace productivity among Indian textile workers.
Research question: Will providing free glasses to presbyopic Indian textile workers increase work productivity?
Design: Investigator-masked, multi-center randomized controlled trial
Rationale: Although presbyopia is safely, effectively and inexpensively treated with glasses, rates of optical correction in LMICs are as low as 10%. 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. 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). The largest reported effect sizes among such trials 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 (21.6%) compared to those in the control group. Costs were low, over half of pickers aged >= 40 years met criteria to receive glasses, and wearing compliance reached nearly 90%. There is interest to understand if these results from the agricultural setting can be extended to other financially-important sectors.
Methods : The investigators will enrol 800 textile workers aged 35 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India. Eligible participants will be randomly assigned to Intervention and Control Groups (1:1). Intervention group participants will receive free reading glasses within a week of undergoing a vision screening at the factory. Control group participants will receive reading glasses at the end of the assessment period (three months after vision screening).
The main outcome 3 months later will be work productivity; secondary outcomes are change in skill grade, change in monthly wage, participants' adherence with spectacle wear, self-assessed self-efficacy score and change of quality of life scores. The intervention cost-effectiveness will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Workers assigned to the Control group will receive similar free glasses at the end of the study assessment (3 months). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacles | Device | Intervention group workers receive free glasses within one week of undergoing vision assessment (September 2021). The assessment period will be three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in change in mean efficiency between intervention and control group | Efficiency is calculated as the proportion of target production realized by a worker per unit time | Over the three month follow-up period from enrolment to study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Three-month change in skill grade | Skill grade ranges from A triple star (highest) to A double star, A star, A, B, and C + (lowest) | Between baseline and study end three months later |
| Change in monthly wage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathan G Congdon, MD, MPH | Contact | 07748751393 | ncongdon1@gmail.com | |
| Smit Gade | Contact | +7023679633 | gade@goodbusiness.com |
| Name | Affiliation | Role |
|---|---|---|
| Nathan G Congdon, MD, MPH | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Business Lab | Recruiting | Bengaluru | Karnataka | 560102 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42045075 | Derived | Pant S, Bagwe S, Esther S, MacKenzie G, Sigwadhi LN, Prakash WD, Chan VF, Gade S, Dhir S, Joshi S, Calderon S, Piyasena MP, Clarke M, Lohfeld L, Cooke M, Gudwin ER, Adhvaryu A, Nyshadham A, Congdon N. PROductivity Study of Presbyopia Elimination in gaRment workers (PROSPER II): a randomised trial on the productivity impact of providing near glasses to Indian garment factory workers. Br J Ophthalmol. 2026 Apr 27:bjo-2025-328563. doi: 10.1136/bjo-2025-328563. Online ahead of print. |
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De-identified data will be made available for download on the Queen's University Belfast website.
Within 6 months of collection, for three years.
Freely available
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2024 | Apr 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| OTHER |
| Clearly | OTHER |
800 textile workers aged 35 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 (3 months after vision assessment).
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Study personnel assessing trial outcomes will be masked as to participants assignment, which will be simplified by the fact that there will be participants with and without glasses at both Intervention and Control. It is not ethical in this setting to provide Control participants with placebo treatment (glasses with zero power lenses), but participants will not be informed of either the overall design of the study or the explicit treatment intervention assignment.
|
Monthly wage (Factory administrative data)
| Between baseline and study end three months later |
| Adherence with spectacle wear | measured weekly by enumerator's unannounced observations of the presence of spectacles worn on the participant's face. | Between baseline and study end three months later |
| Group difference in three-month change in self-assessed self-efficacy scores | Self-assessed self-efficacy scores measured using the Cantril's Ladder, with the best possible score being a 10, and the worst being a 0 (Cantril's Ladder) | Between baseline and conclusion of the study three months later |
| Group difference in three-month change of quality of life scores | Quality of life scores measured using the Andhra Pradesh Eye Disease Study (APEDS) Visual Function Questionnaire (VFQ), with a 5-point Likert scale: 1=No difficulty, 2=Little difficulty, 3=Moderate difficulty, 4=Great difficulty but still can manage, 5=Cannot manage. A highest score represents great difficulty in vision function. Minimum score = 16; Maximum score = 80. | Between baseline and conclusion of the study three months later |
| Cost effectiveness | Full programme costs per individual identified and corrected with presbyopia. Programme costs include costs incurred in screening test, glasses / replacement and direct/indirect costs for facilitating work-based site. Benefit will be measured using work productivity. We will report cost effectiveness distinguishing between study costs and program costs | Between baseline and study end three months later |