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
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Other: Intervention group Other: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||751 participants|
|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|
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.
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.
- 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.
- 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.
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
|Amalgamated Plantations Private Limited (APPL)|
|Tezpur, Assam, India|
|Principal Investigator:||Nathan Congdon||Queen's University, Belfast|