PROductivity Study of Presbyopia Elimination in Rural-dwellers II

NCT ID: NCT04629820

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2024-06-30

Brief Summary

The investigators will conduct a randomized-controlled trial. The participants will be textile workers aged 35 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 800 textile workers aged 35 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 months 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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Spectacles

Intervention Type: DEVICE

Intervention group workers receive free glasses within one week of undergoing vision assessment (September 2021). The assessment period will be three months

Control

Workers assigned to the Control group will receive similar free glasses at the end of the study assessment (3 months).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Spectacles

Intervention group workers receive free glasses within one week of undergoing vision assessment (September 2021). The assessment period will be three months

Intervention Type: DEVICE

Other Intervention Names

Near eyeglasses; Reading glasses

Eligibility Criteria

Inclusion Criteria

• Aged 35 years and older
• Have presbyopia, defined as an unaided near visual acuity of N6.3 or worse in both eyes
• Require a new pair of glasses to improve their near vision
• Have a corrected near visual acuity of N4 or better in both eyes
• Have worked in Shahi's production department as tailors or Kajbutton operators for 6 weeks or more

Exclusion Criteria

• Have ocular pathology in either eye detected during the eye examination, or history of such disease based on self-report
• Have a 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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VisionSpring

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Good Business Lab

UNKNOWN

Sponsor Role: collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Clearly

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Nathan Congdon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathan G Congdon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Good Business Lab

Bengaluru, Karnataka, India

Site Status: RECRUITING

Countries

India

Central Contacts

Nathan G Congdon, MD, MPH

Role: CONTACT

ncongdon1@gmail.com

07748751393

Smit Gade

Role: CONTACT

gade@goodbusiness.com

+7023679633

Facility Contacts

Keerthana Jagadeesh

Role: primary

keerthana.j@goodbusinesslab.org

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MHLS 20_82

Identifier Type: -

Identifier Source: org_study_id