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

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ClinicalTrials.gov Identifier: NCT03228199
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : December 27, 2017
Sponsor:
Collaborators:
Queen's University, Belfast
clearly.world
COMMUNITY EYE CARE FOUNDATION (CECF)
Aravind Eye Care System
University of British Columbia
Amalgamated Plantations Private Limited
VisionSpring
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Presbyopia Other: Intervention group Other: Control Group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 751 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: PROductivity Study of Presbyopia Elimination in Rural-dwellers (PROSPER)
Actual Study Start Date : July 24, 2017
Actual Primary Completion Date : October 7, 2017
Actual Study Completion Date : October 28, 2017

Arm Intervention/treatment
Presbyopic Glasses/ Intervention Group
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
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.

Control Group
Will be deferred to receive spectacles as above, after the 12 weeks evaluation period.
Other: Control Group
Will be deferred to receive spectacles as above, after the 12 week evaluation period.




Primary Outcome Measures :
  1. The impact of near correction of the vision on productivity of agricultural workers in India will be measured. [ Time Frame: 4 to 5 months ]
    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.


Secondary Outcome Measures :
  1. The impact of near correction of the vision on productivity of agricultural workers in India [ Time Frame: 4 to 5 months ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228199


Locations
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India
Amalgamated Plantations Private Limited (APPL)
Tezpur, Assam, India
Sponsors and Collaborators
Congdon Nathan
Queen's University, Belfast
clearly.world
COMMUNITY EYE CARE FOUNDATION (CECF)
Aravind Eye Care System
University of British Columbia
Amalgamated Plantations Private Limited
VisionSpring
Investigators
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Principal Investigator: Nathan Congdon Queen's University, Belfast
  Study Documents (Full-Text)

Documents provided by Congdon Nathan, Sun Yat-sen University:

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Congdon Nathan, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03228199     History of Changes
Other Study ID Numbers: PROSPER (IRB - LNEH/88/2017)
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Congdon Nathan, Sun Yat-sen University:
Randomised Control Trial
Productivity
Agricultural workers
India
Vision correction
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases