Presbyopia Clinical Trial
— PROSPEROfficial title:
PROductivity Study of Presbyopia Elimination in Rural-dwellers (PROSPER)
Verified date | December 2017 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 751 |
Est. completion date | October 28, 2017 |
Est. primary completion date | October 7, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
India | Amalgamated Plantations Private Limited (APPL) | Tezpur | Assam |
Lead Sponsor | Collaborator |
---|---|
Congdon Nathan | Amalgamated Plantations Private Limited, Aravind Eye Care System, clearly.world, COMMUNITY EYE CARE FOUNDATION (CECF), Queen's University, Belfast, University of British Columbia, VisionSpring |
India,
Dalberg Global Development Advisors 2015. Impact study of Essilor's Eye Mitra optician programme in India (a programme of the Essilor Group's 2.5 New Vision Generation division)
EYEIliance, Eyeglasses for global development: Bridging the visual divide. June 2016 report
Frick KD, Joy SM, Wilson DA, Naidoo KS, Holden BA. The Global Burden of Potential Productivity Loss from Uncorrected Presbyopia. Ophthalmology. 2015 Aug;122(8):1706-10. — View Citation
Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12 — View Citation
Johnson R, Zaba J. The link: Vision and illiteracy. J of Behav Optometry 1994;5:41-3
Lu Q, Congdon N, He X, Murthy GV, Yang A, He W. Quality of life and near vision impairment due to functional presbyopia among rural Chinese adults. Invest Ophthalmol Vis Sci. 2011 Jun 13;52(7):4118-23. doi: 10.1167/iovs.10-6353. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The impact of near correction of the vision on productivity of agricultural workers in India will be measured. | The main outcome will be change in mean daily weight of tea picked per worker during a 12 weeks period after randomisation to intervention or control, compared to a 4 weeks period prior to the randomisation. | 4 to 5 months | |
Secondary | The impact of near correction of the vision on productivity of agricultural workers in India | Secondary outcomes will include visual quality of life in both groups, self-reported wear of the study spectacles in the intervention group, self-reported purchase and use of glasses in the control group, independent compliance observations and the proportion of workers who work less than 10 days in a month during the 12 weeks evaluation period. | 4 to 5 months |
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