PROductivity Study of Presbyopia Elimination in Rural-dwellers (PROSPER) (NCT03228199) | Clinical Trial Compass
CompletedNot Applicable
PROductivity Study of Presbyopia Elimination in Rural-dwellers (PROSPER)
India751 participantsStarted 2017-07-24
Plain-language summary
This trial seeks to establish, using a randomized, controlled design, the impact of near eyesight correction on the productivity of presbyopic agricultural workers in India, as measured by weight of tea picked.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Employee of APPL for 1 year
* Aged \>= 40 years
* Habitual near visual acuity of \>= 0.8M (\<=6/12) at 40cm in both eyes, correctable to \<=0.5M (\>=6/7.5) in both eyes with near glasses
* Uncorrected distance vision \>= 6/7.5 in the better-seeing eye
* The participant worked and has data available on weight of tea picked for \>=10 days in the previous 4 weeks (This will largely exclude men in this setting).
* Ability to give informed consent
Exclusion Criteria:
* Eye disease detected on baseline eye exam
* Current ownership of near correction capable of improving near visual acuity to \<= 0.8M (\>= 6/12) in either eye
* Unlikely to complete follow-up due to unsatisfactory work performance, plans to move out of the area, etc.
* Need for distance correction to achieve distance vision of \>= 6/7.5 in the better-seeing eye.
* Inability to achieve best-corrected visual acuity with spherical power glasses only (that is: need for astigmatic correction to achieve best-corrected near visual acuity)
Persons with eye problems detected on the examination will be referred for definitive care at local facilities, and distance refractive errors will be corrected with free bifocals for those with uncorrected VA \< 6/12 in the better-seeing eye.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The impact of near correction of the vision on productivity of agricultural workers in India will be measured.