MedTrace Logo

PROductivity Study of Presbyopia Elimination in Rural-dwellers III

NCT04654013 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1291

Last updated 2024-04-29

No results posted yet for this study

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

Interventions

DEVICE

Spectacles

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).

Sponsors & Collaborators

  • VisionSpring

    collaborator OTHER

  • Clearly

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Good Business Lab

    collaborator UNKNOWN

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    collaborator OTHER

  • Queen's University, Belfast

    lead OTHER

Principal Investigators

  • Nathan G Congdon, MD, MPH · Queen's University, Belfast

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-21
Primary Completion
2023-03-30
Completion
2025-06-05

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654013 on ClinicalTrials.gov