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临床试验/NCT03228199
NCT03228199已完成不适用

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

Congdon Nathan1 个研究点 分布在 1 个国家目标入组 751 人开始时间: 2017年7月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
751
试验地点
1
主要终点
The impact of near correction of the vision on productivity of agricultural workers in India will be measured.

研究概览

简要总结

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.

详细描述

Main research question being addressed: 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.

Primary outcomes to be measured: Change in mean daily weight of tea picked per worker during a 12 weeks period after randomisation compared to a 4 weeks baseline period prior to randomisation. (See details below under Main Outcome.)

I. Background: Importance of research topic, Particular Features of setting Uncorrected presbyopia is an expensive problem for the world. Lost productivity among adults who need eyeglasses has been estimated to cost the global economy $227 billion every year, [1,2] and illiteracy may lead to a further $3 trillion in annual global economic losses. It has been shown that 74% of illiterate adults failed one or more parts of a vision screening. [3] However, in order to motivate governments, industry and other key stakeholders to invest in solving the problem of uncorrected near vision in adults, higher-quality data on the productivity impact of correction are needed. Current studies are suggestive, but carefully-performed randomized trials are still lacking in the published literature.

An unpublished University of Michigan (USA) working paper found that correcting near-vision loss with glasses yields an increase in productivity of up to 34%, though no control group was included, and the outcome assessed was not precisely defined. An unpublished impact assessment conducted by Building Resources Across Communities (BRAC), the world's largest NGO in the number of staff, concluded that 90% of individuals experiencing near-vision loss in Bangladesh encountered problems with their daily work; and, on average, 23% reported that their income was compromised.[4] In Rwanda, Lifetime Consulting & Partners found that workers with poor vision who did not wear glasses were three times more likely to be asked by supervisors to repeat their work of sorting coffee beans than after receiving and wearing glasses.[4] Again, no control group was included, and this work has not been published. Furthermore, a Dalberg Global Development Advisors study of adults in India who had their vision corrected with glasses found that 65% reported an increase in independence in movement and travel, and 59% reported improved work productivity, [5] but these outcomes were not confirmed quantitatively or objectively. Finally, a population study of 1008 older adults in Shenyang, northern China, found that those with uncorrected presbyopia (69%) were more likely to report diminished accomplishment due to vision (P = 0.01, adjusted for age, sex, education, and distance vision) than were those without presbyopia. [6] The impact of correcting presbyopia was not studied in a prospective fashion.

In summary, available data are consistent with the idea that correcting presbyopia can lead to significant improvements in productivity among adult workers. However, in the absence of high-quality randomized trials, it is very difficult to be certain about cause and effect: it is equally plausible that the economic burden of poverty could result in failure to purchase glasses, rather than the reverse. Lack of control groups and carefully-defined productivity outcomes in many studies further hinder interpretation. Policy makers and industry partners require more convincing data in order to commit to the support of programs of vision correction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Intervention group (Other)

Control Group

Other

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

干预措施: Control Group (Other)

结局指标

主要结局

The impact of near correction of the vision on productivity of agricultural workers in India will be measured.

时间窗: 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.

次要结局

  • The impact of near correction of the vision on productivity of agricultural workers in India(4 to 5 months)

研究者

发起方
Congdon Nathan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Congdon Nathan

Professor

Sun Yat-sen University

研究点 (1)

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