PROductivity Study of Presbyopia Elimination in Rural-dwellers III

NCT04654013 | Active Not Recruiting

• 1 other identifier: MHLS 20_84
• Study Type: interventional
• Target: 1,291
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct an embedded mixed methods study in which the primary approach is a randomized controlled trial (RCT), and the secondary or embedded approach is a descriptive qualitative study. The aim of the RCT is to assess the impact of presbyopic correction on workplace productivity and retention in the textile industry in a low middle-income country. Additional qualitative data will be collected to enhance understanding of factors linked to reasons why enrolled sew-ers left their job during the study. Participants will be textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India.

Conditions

Presbyopia

Keywords

Presbyopia; Refractive error; Work retention; Spectacle wear compliance; Work efficiency

Outcome Measures

Primary Outcomes (1)

• Work retention

  Proportion of textile workers who continue to work at the textile factories assessed from trial entry to closure as recorded in Shahi's Human Resource Management Database

  September 2022 to May 2024; Over the 18 month follow-up period from enrolment to study completion

Secondary Outcomes (14)

• Compliance with spectacle wear

  3, 6, 9, 12, 15 and 18 months after enrolment

• Change in work satisfaction

  Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

• Change in feeling valued-at-work

  Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

• Change in likeliness to stay at work

  Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

• Change in work efficiency

  Between baseline and 3, 6, 9, 12, 15 and 18 months after enrolment

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Device: Spectacles

Control

NO INTERVENTION

Workers assigned to the Control group will receive similar free glasses at the end of the study assessment (18 months).

Interventions

Spectacles DEVICE

Intervention group workers receive free glasses within one week of undergoing vision assessment (May 2022). The duration of the treatment for the Intervention participants will depend on when they leave employment at the factor. If they stayed for the full duration of the trial, they will have undergone a maximum of 18 months (December 2023).

Also known as: Eyeglasses, Reading glasses

Intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 25cm, 30cm, 40cm, and 50cm based on workers working distance
• Employed at the factory for \>=3months in the sewing department

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University, Belfast: lead
• VisionSpring: collaborator
• Clearly: collaborator
• University of Michigan: collaborator
• Good Business Lab: collaborator
• Zhongshan Ophthalmic Center, Sun Yat-sen University: collaborator

Study Sites (1)

Good Business Lab

Bengaluru, Karantaka, 560102, India

Location

MeSH Terms

Conditions

Presbyopia; Refractive Errors

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Nathan G Congdon, MD, MPH

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1260 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 (18 months after vision assessment).

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: December 4, 2020
• Study Start: May 21, 2022
• Primary Completion: March 30, 2023
• Study Completion: June 5, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

IN (1)