Perfecting Refraction in India With Superior Service Models

NCT03983278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2024-10-30

No results posted yet for this study

Summary

Some programs do the screening, refraction testing and provision of spectacles to children entirely in the school setting ("School Model"). One strength of such programs is that most children at school who need spectacles get them. However, sustainability is poor, because spectacles cannot be sold in many schools and there may be too few refractionists to cover all schools in most countries. Other programs provide vision screening at schools but refer children who fail vision screening to nearby facilities for refraction and distribution/sale of spectacles ("Referral Model"). This model's strengths include a lower demand for refractionists and opportunities for the spectacles to be sold. However, a disadvantage is that most of the referred children do not attend the specialist facility. One way to improve this might be to enhance the Referral Model and a recent USAID review by Priya Reddy and Ken Bassett showed that involving teachers in vision screening and family counseling significantly increases children's use of spectacles. Therefore, at 141 schools in India, involving over 42,300 children (assuming a minimum of 300 children/school), the investigators will study an "Improved Referral Model," with strong teacher involvement, to investigate the potential benefits of combining the lower costs of the "Referral Models" with the high uptake of the "School Model". The investigators will also assess the effects of allowing parents to purchase enhanced spectacles, rather than having their child use free spectacles. Children will be randomized by the school to the "School Model," "(Improved) Referral Model" or the "(Improved) Referral Model + Cost Recovery (sale of "upgrade spectacles" alongside offering free spectacles. The main study outcome will be program cost-effectiveness, defined as the program cost per child identified with correctable refractive error, who receives spectacles, and wears them at an un-announced visit between 8 to 12 weeks after distribution. Profit on spectacles sold in the "Referral + Cost Recovery" group will be subtracted from the program costs in this study group. The groups will be compared, with and without adjustment for baseline characteristics.

Conditions

  • Refractive Error

Interventions

OTHER

School Model

Free delivery of glasses at the school within two weeks after screening

OTHER

Referral Model

After the primary screening children referred to nearby Vision Center/ secondary center for refraction and delivery of free glasses.

OTHER

Referral Model + Cost Recovery

After the screening children referred to Vision Center for refraction and delivery of free glasses with the option to purchase "upgrade glasses"

Sponsors & Collaborators

  • Aravind Eye Care System

    collaborator OTHER
  • PBMA's H.V. Desai Eye Hospital, Pune

    collaborator UNKNOWN
  • Sadguru Netra Chikitsalaya, Post Graduate Institute Of Ophthalmology (New SNC)

    collaborator OTHER
  • Orbis

    collaborator OTHER
  • Padmashree Dr. D. Y. Patil Medical College

    collaborator OTHER
  • Queen's University, Belfast

    collaborator OTHER
  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Nathan Congdon · Centre for Public Health, Queen's University Belfast

  • Priya Adhisesha Reddy · Centre for Public Health, Queen's University Belfast

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-12
Primary Completion
2020-03-21
Completion
2020-03-30

Countries

  • India

Study Locations

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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 NCT03983278 on ClinicalTrials.gov