CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 162 enrolled
Drug / intervention
School Model +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03983278
NCT03983278N/ACompleted

PRISSM (Perfecting Refraction in India With Superior Service Models): A Cluster-randomized Controlled Trial of Three Models of School-based Spectacle Service Delivery in India

Sun Yat-sen University·interventional·Posted Jun 12, 2019·Updated Oct 30, 2024

In Brief

A clinical study evaluating School Model, Referral Model, and 1 other intervention for Refractive Error. Completed, enrolled 162 participants across 3 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 12, 2019
Enrollment StartAug 12, 2019
Primary CompletionMar 21, 2020
Study CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.1 years ago

Interventions

School Modelother

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

Referral Modelother

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

Referral Model + Cost Recoveryother

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