此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Productivity Study of Presbyopia Improvement in Textile Workers

To establish, using a randomized, controlled design, the impact of near vision correction on the productivity of presbyopic textile workers in China, as measured by the change of monthly income.

研究概览

地位

尚未招聘

条件

详细说明

Sustainable development is considered to be a major development strategy to meet rapid economic and social development in China. China is one of the biggest manufacturing hubs in the world. With the rapid development of economy, the health of manufacturing workers is closely related to productivity. In some low-income developing countries, studies have focused on improving the health of manufacturing workers to improve productivity .Most of the studies focused on improving the nutritional intake of workers has a significant effect on improving work efficiency and productivity .

As the global aging is becoming an critical issue for both health and economics, the health of the working population over the age of 45 is of greater concern in low - and middle-income developing countries. China has a workforce of 980 million people (aged 15 to 60). Urban workers and blue-collar workers account for nearly 310 million. With the aging population increased, presbyopia is becoming more and more serious, and it also affects the labor group that needs to work in close proximity. Studies have proved that refractive correction for tea pickers with old vision can effectively improve the yield of tea pickers and increase personal income.Because Guangdong area textile industry is developed, textile worker population is large. Most front-line textile workers need to work in close proximity for a long time, and the problem of aging productivity is increasingly obvious. At present, no relevant studies have explored whether presbyopia affects the work efficiency of textile workers who work in close proximity.

In this study, a randomized controlled clinical study will be conducted on front-line textile workers with presbyopia to explore whether refractive correction can improve labor income and relieve symptoms of visual fatigue for textile workers aged 40 years or above who work in the front-line.

研究类型

介入性

注册 (预期的)

136

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Guangdong
      • Foshan、Guangdong、中国、510000
        • Gaoming, Foshan, Guangdong
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Employee of E-square for 6 months;
  • Aged >= 40 years;
  • Quantifiable near visual task workers;
  • Habitual near visual acuity of >= 0.8M (<=6/12) at 40cm in both eyes, correctable to <=0.5M (>=6/7.5);
  • Near correction spherical equivalent refractive error >= +0.50D or astigmatism <-1.00D;
  • Asthenopia symptoms reported ( Asthenopia questionnaire score >= 16) Ability to give informed consent

Exclusion Criteria:

  • Ocular surgery done in the past 3 months;
  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Presbyopic Glasses/ Intervention Group
Immediate provision of a free pair of spherical presbyopic glasses to correct the worker's vision for optimal working distance as measured before intervention.
Immediate provision of a free pair of spherical presbyopic glasses to correct the worker's vision for optimal picking distance, astigmatism is corrected.
无干预:Control Group
Will be deferred to receive spectacles as above, after the 4 weeks evaluation period.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The rate of income change of textile workers
大体时间:4 weeks
The rate of income change over baseline.
4 weeks

次要结果测量

结果测量
措施说明
大体时间
The quality of vision function
大体时间:4 weeks
Secondary outcome will be the quality of vision function in both groups.National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25 ) questionnaire will be used to measure the quality of vision function.For the NEI-VFQ-25, a composite score (25 items) and near activities sub score (two items) were created on 0-100 scales.
4 weeks
Percentage of glasses wear in intervention group, as well as the purchase and use of glasses in control group.
大体时间:4 weeks
Independent compliance observation of wear of the study spectacles in the intervention group, self-reported purchase and use of glasses in the control group will be recorded.
4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Yangfa Zeng, Master、Zhongshan Ophthalmic Center, Sun Yat-sen University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2019年12月13日

初级完成 (预期的)

2019年12月21日

研究完成 (预期的)

2049年12月31日

研究注册日期

首次提交

2019年11月19日

首先提交符合 QC 标准的

2019年11月19日

首次发布 (实际的)

2019年11月21日

研究记录更新

最后更新发布 (实际的)

2019年12月11日

上次提交的符合 QC 标准的更新

2019年12月9日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SYSU-OPH-005

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅