PROductivity Study of Presbyopia Elimination in Rural-dwellers II

NCT04629820 | Recruiting

• 1 other identifier: MHLS 20_82
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Keywords

Presbyopia; Refractive error; Work productivity; Spectacle wear compliance

Outcome Measures

Primary Outcomes (1)

• 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

  Over the three month follow-up period from enrolment to study completion

Secondary Outcomes (6)

• Three-month change in skill grade

  Between baseline and study end three months later

• Change in monthly wage

  Between baseline and study end three months later

• Adherence with spectacle wear

  Between baseline and study end three months later

• Group difference in three-month change in self-assessed self-efficacy scores

  Between baseline and conclusion of the study three months later

• Group difference in three-month change of quality of life scores

  Between baseline and conclusion of the study three months later

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 (3 months).

Interventions

Spectacles DEVICE

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

Also known as: Near eyeglasses, Reading glasses

Intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Good Business Lab

Bengaluru, Karnataka, 560102, India

RECRUITING

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

Central Study Contacts

Nathan G Congdon, MD, MPH

CONTACT

07748751393; ncongdon1@gmail.com

Smit Gade

CONTACT

+7023679633; gade@goodbusiness.com

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: 800 textile workers aged 35 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).

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 16, 2020
• Study Start: August 3, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within 6 months of collection, for three years.
• Access Criteria: Freely available

Locations

IN (1)