PROductivity Study of Presbyopia Elimination in Rural-dwellers (PROSPER)

NCT03228199 | Completed DMC

• 1 other identifier: PROSPER (IRB - LNEH/88/2017)
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Presbyopia

Keywords

Randomised Control Trial; Productivity; Agricultural workers; India; Vision correction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The impact of near correction of the vision on productivity of agricultural workers in India

  4 to 5 months

Study Arms (2)

Presbyopic Glasses/ Intervention Group

OTHER

Immediate provision of a free pair of spherical presbyopic glasses to correct the worker's vision for optimal picking distance as measured using a chart placed at the top of a typical tea bush.

Other: Intervention group

Control Group

OTHER

Will be deferred to receive spectacles as above, after the 12 weeks evaluation period.

Other: Control Group

Interventions

Intervention group OTHER

Will immediately receive a free pair of presbyopic glasses through the Clear Vision Workplace program. These glasses will correct the worker's vision at their usual working distance, and will not correct astigmatism.

Presbyopic Glasses/ Intervention Group

Control Group OTHER

Will be deferred to receive spectacles as above, after the 12 week evaluation period.

Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Congdon Nathan: lead
• Queen's University, Belfast: collaborator
• Clearly: collaborator
• COMMUNITY EYE CARE FOUNDATION (CECF): collaborator
• Aravind Eye Care System: collaborator
• University of British Columbia: collaborator
• Amalgamated Plantations Private Limited: collaborator
• VisionSpring: collaborator

Study Sites (1)

Amalgamated Plantations Private Limited (APPL)

Tezpur, Assam, India

Location

Related Publications (7)

• 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.

  PMID: 23109740 RESULT

• 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. doi: 10.1016/j.ophtha.2015.04.014.

  PMID: 26190438 RESULT

• Johnson R, Zaba J. The link: Vision and illiteracy. J of Behav Optometry 1994;5:41-3

  RESULT

• EYEIliance, Eyeglasses for global development: Bridging the visual divide. June 2016 report

  RESULT

• 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)

  RESULT

• 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.

  PMID: 21508106 RESULT

• Reddy PA, Congdon N, MacKenzie G, Gogate P, Wen Q, Jan C, Clarke M, Kassalow J, Gudwin E, O'Neill C, Jin L, Tang J, Bassett K, Cherwek DH, Ali R. Effect of providing near glasses on productivity among rural Indian tea workers with presbyopia (PROSPER): a randomised trial. Lancet Glob Health. 2018 Sep;6(9):e1019-e1027. doi: 10.1016/S2214-109X(18)30329-2. Epub 2018 Jul 23.

  PMID: 30049615 DERIVED

MeSH Terms

Conditions

Presbyopia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nathan Congdon

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Main outcome and masking: The daily mean weight of tea picked will be calculated for each worker for the 4 weeks baseline and for the 12 weeks evaluation period. The difference between these two means will be calculated for each worker, and the mean of this value will be calculated for each randomised group, with the main study outcome being the difference between these values for each group. It will not be practical to mask participants as to their study group assignment (the investigators do not feel that providing sham near correction of Plano power is ethical). However, the APPL staff measuring the weight and quality outcomes will be masked to a worker's group assignment by having an intermediate person receive the tea from the worker and carry it to the weighing station each day.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomization, Balancing, and Intervention: Eligible workers completing baseline productivity assessment will be enrolled into the study, and assigned at random to one of the below groups: Intervention Group: Will immediately receive a free pair of presbyopic glasses through the Clear Vision Workplace program. These glasses will correct the worker's vision at their usual working distance by placing the vision chart on the top of a tea bush and directing the participant to stand as usual in picking tea. The gasses will not correct astigmatism. Distance refractive errors will be corrected for those with uncorrected VA \< 6/12 in the better-seeing eye. Control Group: Will be deferred to receive free presbyopic spectacles after the 12 weeks evaluation period.

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: July 24, 2017
• Study Start: July 24, 2017
• Primary Completion: October 7, 2017
• Study Completion: October 28, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)