PROductivity Study of Presbyopia Elimination in Rural-dwellers II (PROSPERII)
Primary Purpose
Presbyopia
Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Spectacles
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Refractive error, Work productivity, Spectacle wear compliance
Eligibility Criteria
Inclusion Criteria:
- Aged 30 years and above
- Distance visual acuity >= 6/12 in both eyes
- Presence of presbyopia, defined as the inability, correctable with reading glasses, to read the N8 line using both eyes together, on a tumbling near vision chart at a distance of 40cm
- Employed at the factory for >=3months in the sewing department
Exclusion Criteria:
- Current ownership of reading or distance glasses (regardless of accuracy)
- Obvious evidence of ocular disease in either eye detected during the eye examination, or history of such disease based on self-report
- Low likelihood of completing follow-up in the study due to current plans to move out of the area or leave employment at Shahi during the follow-up period
Sites / Locations
- Good Business LabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Workers assigned to the intervention group will receive free spectacles of a design they select, based on the worker's measured refractive power and dispensed one week later at the factory by the study ophthalmic personnel.
Workers assigned to the Control group will receive similar free glasses at the end of the study assessment (3 months).
Outcomes
Primary Outcome Measures
Difference in change in mean efficiency between intervention and control group
Efficiency is calculated as the proportion of target production realized by a worker per unit time
Secondary Outcome Measures
Three-month change in skill grade
Skill grade ranges from A triple star (highest) to A double star, A star, A, B, and C + (lowest)
Change in monthly wage
Monthly wage
Adherence with spectacle wear
measured weekly by supervisor's unannounced direct observations of the presence of spectacles worn on the participant's face.
Group difference in three-month change in self-assessed self-efficacy scores
Self-assessed self-efficacy scores measured using the Cantril's Ladder, with the best possible score being a 10, and the worst being a 0
Group difference in three-month change of quality of life scores
Quality of life scores measured using the THRIVE Near Vision Quality of Life tool, a Likert Scale ranging from 1 (least affected) to 5 (worst affected).
Cost effectiveness
Full programme costs per individual identified and corrected with presbyopia. Programme costs include costs incurred in screening test, glasses / replacement and direct/indirect costs for facilitating work-based site. Effectiveness will be measured using work productivity
Full Information
NCT ID
NCT04629820
First Posted
October 21, 2020
Last Updated
May 25, 2022
Sponsor
Queen's University, Belfast
Collaborators
VisionSpring, University of Michigan, Good Business Lab, Zhongshan Ophthalmic Center, Sun Yat-sen University, Clearly
1. Study Identification
Unique Protocol Identification Number
NCT04629820
Brief Title
PROductivity Study of Presbyopia Elimination in Rural-dwellers II
Acronym
PROSPERII
Official Title
Effects of Near Vision Spectacle Correction on Work Productivity Among Textile Factory Workers in India
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
May 24, 2024 (Anticipated)
Study Completion Date
May 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
VisionSpring, University of Michigan, Good Business Lab, Zhongshan Ophthalmic Center, Sun Yat-sen University, Clearly
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators will conduct a randomized-controlled trial. The participants will be textile workers aged 30 years and above with uncorrected presbyopia who are employed by a single Indian garment manufacturer - employed by Shahi Exports Private Limited, Karnataka, India - at facilities equipped to measure individual productivity. PROSPER II will assess the impact of free reading glasses on productivity for workers in a textile factory.
Detailed Description
Globally, 3 billion people do not have the eyeglasses they need to earn, learn, travel safely in traffic and participate in civic life. Among these, 1.1 billion people lack a simple pair of reading glasses to correct impaired near vision, called presbyopia. Presbyopia, the essentially universal decline in unaided near vision that occurs with aging, is the world's most common cause of vision impairment. Loss of accommodation (ability to change focus from distance to near) due to presbyopia can begin as early as age 30 years, commonly becomes functionally apparent by 40, and is essentially complete by 55, meaning that presbyopia is most common at the height of the working years.
Study Plan: This is a randomized trial designed to assess the impact of free spectacles on workplace productivity among Indian textile workers.
Research question: Will providing free glasses to presbyopic Indian textile workers increase work productivity?
Design: Investigator-masked, multi-center randomized controlled trial
Rationale: Although presbyopia is safely, effectively and inexpensively treated with glasses, rates of optical correction in LMICs are as low as 10%. The global productivity loss due to uncorrected presbyopia has been estimated to exceed US$25 billion, and presbyopia is shown to be associated with significant impairment in activities of daily living. Few trials have been published which address the question of whether healthcare interventions can improve work performance as well as workplace retention, especially among persons over the age of 40 in low and middle-income countries (LMICs). The largest reported effect sizes among such trials was the PROSPER trial, which showed that providing inexpensive near vision glasses increased the daily weight of tea picked among presbyopic, mostly-female Indian agricultural workers by more than 5 kg (21.6%) compared to those in the control group. Costs were low, over half of pickers aged >= 40 years met criteria to receive glasses, and wearing compliance reached nearly 90%. There is interest to understand if these results from the agricultural setting can be extended to other financially-important sectors.
Methods : The investigators will enrol 500 textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India. Eligible participants will be randomly assigned to Intervention and Control Groups (1:1). Intervention group participants will receive free reading glasses within a week of undergoing a vision screening at the factory. Control group participants will receive reading glasses at the end of the assessment period (three months after vision screening).
The main outcome 3 month later will be work productivity; secondary outcomes are change in skill grade, change in monthly wage, participants' adherence with spectacle wear, self-assessed self-efficacy score and change of quality of life scores. The intervention cost-effectiveness will be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia, Refractive error, Work productivity, Spectacle wear compliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
500 textile workers aged 30 years and above with uncorrected presbyopia will be randomized to receive free glasses within one week of undergoing vision assessment, or free glasses at the end of the study assessment (3 months after vision assessment).
Masking
InvestigatorOutcomes Assessor
Masking Description
Study personnel assessing trial outcomes will be masked as to participants assignment, which will be simplified by the fact that there will be participants with and without glasses at both Intervention and Control. It is not ethical in this setting to provide Control participants with placebo treatment (glasses with zero power lenses), but participants will not be informed of either the overall design of the study or the explicit treatment intervention assignment.
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Workers assigned to the intervention group will receive free spectacles of a design they select, based on the worker's measured refractive power and dispensed one week later at the factory by the study ophthalmic personnel.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Workers assigned to the Control group will receive similar free glasses at the end of the study assessment (3 months).
Intervention Type
Device
Intervention Name(s)
Spectacles
Other Intervention Name(s)
Near eyeglasses, Reading glasses
Intervention Description
Intervention group workers receive free glasses within one week of undergoing vision assessment (September 2021). The assessment period will be three months
Primary Outcome Measure Information:
Title
Difference in change in mean efficiency between intervention and control group
Description
Efficiency is calculated as the proportion of target production realized by a worker per unit time
Time Frame
Over the three month follow-up period from enrolment to study completion
Secondary Outcome Measure Information:
Title
Three-month change in skill grade
Description
Skill grade ranges from A triple star (highest) to A double star, A star, A, B, and C + (lowest)
Time Frame
Between baseline and study end three months later
Title
Change in monthly wage
Description
Monthly wage
Time Frame
Between baseline and study end three months later
Title
Adherence with spectacle wear
Description
measured weekly by supervisor's unannounced direct observations of the presence of spectacles worn on the participant's face.
Time Frame
Between baseline and study end three months later
Title
Group difference in three-month change in self-assessed self-efficacy scores
Description
Self-assessed self-efficacy scores measured using the Cantril's Ladder, with the best possible score being a 10, and the worst being a 0
Time Frame
Between baseline and conclusion of the study three months later
Title
Group difference in three-month change of quality of life scores
Description
Quality of life scores measured using the THRIVE Near Vision Quality of Life tool, a Likert Scale ranging from 1 (least affected) to 5 (worst affected).
Time Frame
Between baseline and conclusion of the study three months later
Title
Cost effectiveness
Description
Full programme costs per individual identified and corrected with presbyopia. Programme costs include costs incurred in screening test, glasses / replacement and direct/indirect costs for facilitating work-based site. Effectiveness will be measured using work productivity
Time Frame
Between baseline and study end three months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 30 years and above
Distance visual acuity >= 6/12 in both eyes
Presence of presbyopia, defined as the inability, correctable with reading glasses, to read the N8 line using both eyes together, on a tumbling near vision chart at a distance of 40cm
Employed at the factory for >=3months in the sewing department
Exclusion Criteria:
Current ownership of reading or distance glasses (regardless of accuracy)
Obvious evidence of ocular disease in either eye detected during the eye examination, or history of such disease based on self-report
Low likelihood of completing follow-up in the study due to current plans to move out of the area or leave employment at Shahi during the follow-up period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan G Congdon, MD, MPH
Phone
07748751393
Email
ncongdon1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Smit Gade
Phone
+7023679633
Email
gade@goodbusiness.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan G Congdon, MD, MPH
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Business Lab
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560102
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simranjeet Dhir
Email
simranjeet.d@goodbusinesslab.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made available for download on the Queen's University Belfast website.
IPD Sharing Time Frame
Within 6 months of collection, for three years.
IPD Sharing Access Criteria
Freely available
IPD Sharing URL
http://qub.ac.uk
Learn more about this trial
PROductivity Study of Presbyopia Elimination in Rural-dwellers II
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