Productivity Study of Presbyopia Improvement in Textile Workers
1 other identifier
interventional
136
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2019
CompletedFirst Posted
Study publicly available on registry
November 21, 2019
CompletedStudy Start
First participant enrolled
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2049
ExpectedDecember 11, 2019
December 1, 2019
8 days
November 19, 2019
December 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of income change of textile workers
The rate of income change over baseline.
4 weeks
Secondary Outcomes (2)
The quality of vision function
4 weeks
Percentage of glasses wear in intervention group, as well as the purchase and use of glasses in control group.
4 weeks
Study Arms (2)
Presbyopic Glasses/ Intervention Group
EXPERIMENTALImmediate provision of a free pair of spherical presbyopic glasses to correct the worker's vision for optimal working distance as measured before intervention.
Control Group
NO INTERVENTIONWill be deferred to receive spectacles as above, after the 4 weeks evaluation period.
Interventions
Immediate provision of a free pair of spherical presbyopic glasses to correct the worker's vision for optimal picking distance, astigmatism is corrected.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaoming, Foshan, Guangdong
Foshan, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yangfa Zeng, Master
Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2019
First Posted
November 21, 2019
Study Start
December 13, 2019
Primary Completion
December 21, 2019
Study Completion (Estimated)
December 31, 2049
Last Updated
December 11, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share