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Productivity Study of Presbyopia Improvement in Textile Workers

Primary Purpose

Presbyopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Presbyopic Glasses/ Intervention Group
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Presbyopia focused on measuring Presbyopia, textile worker

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gaoming, Foshan, Guangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Presbyopic Glasses/ Intervention Group

Control Group

Arm Description

Immediate provision of a free pair of spherical presbyopic glasses to correct the worker's vision for optimal working distance as measured before intervention.

Will be deferred to receive spectacles as above, after the 4 weeks evaluation period.

Outcomes

Primary Outcome Measures

The rate of income change of textile workers
The rate of income change over baseline.

Secondary Outcome Measures

The quality of vision function
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.
Percentage of glasses wear in intervention group, as well as the purchase and use of glasses in control group.
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.

Full Information

First Posted
November 19, 2019
Last Updated
December 9, 2019
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04172935
Brief Title
Productivity Study of Presbyopia Improvement in Textile Workers
Official Title
Productivity Study of Presbyopia Improvement in Textile Workers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 13, 2019 (Anticipated)
Primary Completion Date
December 21, 2019 (Anticipated)
Study Completion Date
December 31, 2049 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia, textile worker

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Presbyopic Glasses/ Intervention Group
Arm Type
Experimental
Arm Description
Immediate provision of a free pair of spherical presbyopic glasses to correct the worker's vision for optimal working distance as measured before intervention.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Will be deferred to receive spectacles as above, after the 4 weeks evaluation period.
Intervention Type
Device
Intervention Name(s)
Presbyopic Glasses/ Intervention Group
Intervention Description
Immediate provision of a free pair of spherical presbyopic glasses to correct the worker's vision for optimal picking distance, astigmatism is corrected.
Primary Outcome Measure Information:
Title
The rate of income change of textile workers
Description
The rate of income change over baseline.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The quality of vision function
Description
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.
Time Frame
4 weeks
Title
Percentage of glasses wear in intervention group, as well as the purchase and use of glasses in control group.
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuting LI, Master
Phone
+86-020-87334687
Email
liyuting@gzzoc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qianyun Chen, Master
Phone
+86-020-66610720
Email
chenqianyun@gzzoc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yangfa Zeng, Master
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Gaoming, Foshan, Guangdong
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuting LI, Master
Phone
+86-020-87334687
Email
ytdorothy@163.com
First Name & Middle Initial & Last Name & Degree
Qianyun Chen, bachelor
Phone
+86-020-87334687
Email
torunchen@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Productivity Study of Presbyopia Improvement in Textile Workers

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