Perfecting Refraction in India With Superior Service Models

NCT03983278 | Completed DMC

• 1 other identifier: PRISSM (19.09v3)
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Child; Refractive Error; Myopia; School screening; Cost effectiveness; India

Outcome Measures

Primary Outcomes (1)

• Program cost-effectiveness

  Program cost per child identified with correctable refractive error, who receives spectacles and wears them at an un-announced visit 8 to 12 weeks after distribution. Income from sales of spectacles in the "Referral + Cost Recovery" group will be subtracted from the program costs. The groups will be compared, with and without adjustment for baseline characteristics.

  13 months

Secondary Outcomes (3)

• Proportion of children receiving spectacles who are wearing them at the time of un-announced visit between 8 and 12 weeks

  12 months

• Purchase rates of upgrade spectacles in the Referral + Cost Recovery Group

  12 months

• Teacher and student reports of rates of teacher interventions in the two Referral groups

  12 months

Study Arms (3)

School Model

EXPERIMENTAL

School Model (n=47 schools): Vision screening will be carried out by the vision screeners; refraction will be done at the schools by refractionists, and children who need them will be given free spectacles at the school within two weeks.

Other: School Model

Referral Model

EXPERIMENTAL

Referral Model (47 schools): Vision screening carried out by the vision screeners, and children are referred to nearby Vision Center/ secondary center for refraction and delivery of free spectacles. Teachers will contact families not presenting for follow-up care and for spectacle compliance through SMS, phone call and notations in the school diary.

Other: Referral Model

Referral Model + Cost Recovery

EXPERIMENTAL

Referral Model + Cost Recovery (47 schools): Vision screening carried out by the vision screeners; children referred to Vision Center for refraction and delivery of spectacles with an option to purchase "upgrade spectacles" (which was shown to be appealing to families in the recent PRICE study. These spectacles have scratch-proof coatings and designs selected to appeal to local children. Teachers will contact families not presenting for follow-up care and for spectacle compliance through SMS, phone call and notations in the school diary.

Other: Referral Model + Cost Recovery

Interventions

School Model OTHER

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

School Model

Referral Model OTHER

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

Referral Model

Referral Model + Cost Recovery OTHER

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

Referral Model + Cost Recovery

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Eligibility: Enrolment criteria:
• Children in randomly-selected 6th to 10th grades in selected schools with presenting visual acuity \<= 6/9.6 (0.2 LogMAR) in either eye.
• Children who already own spectacles will be requested to bring their spectacles on the day of screening, and children whose vision with existing spectacles meets study criteria will be eligible.
• Entry into the trial only requires that a child fail vision screening, which is assessed in the same way for all three randomized groups.

You may not qualify if:

• Parents returning the form indicating they do not wish their child to participate;
• no Vision Center within 50 km of the child's home (a rare occurrence in the REACH network).
• If the child is incapable of completing visual acuity screening in both eyes for any reason.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Aravind Eye Care System: collaborator
• PBMA's H.V. Desai Eye Hospital, Pune: collaborator
• Sadguru Netra Chikitsalaya, Post Graduate Institute Of Ophthalmology (New SNC): collaborator
• Orbis: collaborator
• Padmashree Dr. D. Y. Patil Medical College: collaborator
• Queen's University, Belfast: collaborator

Study Sites (3)

Sadguru Netra Chikitsalaya, Chitrakoot

Chitrakoot Dham, India

Location

Aravind Eye Hospital

Madurai, India

Location

PBMA's H. V. Desai Eye Hospital

Pune, India

Location

Related Publications (15)

• Dandona R, Dandona L, Srinivas M, Sahare P, Narsaiah S, Munoz SR, Pokharel GP, Ellwein LB. Refractive error in children in a rural population in India. Invest Ophthalmol Vis Sci. 2002 Mar;43(3):615-22.

  PMID: 11867575 BACKGROUND

• Murthy GV, Gupta SK, Ellwein LB, Munoz SR, Pokharel GP, Sanga L, Bachani D. Refractive error in children in an urban population in New Delhi. Invest Ophthalmol Vis Sci. 2002 Mar;43(3):623-31.

  PMID: 11867576 BACKGROUND

• Gogate P, Mukhopadhyaya D, Mahadik A, Naduvilath TJ, Sane S, Shinde A, Holden B. Spectacle compliance amongst rural secondary school children in Pune district, India. Indian J Ophthalmol. 2013 Jan-Feb;61(1):8-12. doi: 10.4103/0301-4738.99996.

  PMID: 23275214 BACKGROUND

• Ma X, Zhou Z, Yi H, Pang X, Shi Y, Chen Q, Meltzer ME, le Cessie S, He M, Rozelle S, Liu Y, Congdon N. Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial. BMJ. 2014 Sep 23;349:g5740. doi: 10.1136/bmj.g5740.

  PMID: 25249453 BACKGROUND

• How many children are there in India? http://www.childlineindia.org.in/child-in-india.htm

  BACKGROUND

• Pineles SL, Kraker RT, VanderVeen DK, Hutchinson AK, Galvin JA, Wilson LB, Lambert SR. Atropine for the Prevention of Myopia Progression in Children: A Report by the American Academy of Ophthalmology. Ophthalmology. 2017 Dec;124(12):1857-1866. doi: 10.1016/j.ophtha.2017.05.032. Epub 2017 Jun 29.

  PMID: 28669492 BACKGROUND

• Xiong S, Sankaridurg P, Naduvilath T, Zang J, Zou H, Zhu J, Lv M, He X, Xu X. Time spent in outdoor activities in relation to myopia prevention and control: a meta-analysis and systematic review. Acta Ophthalmol. 2017 Sep;95(6):551-566. doi: 10.1111/aos.13403. Epub 2017 Mar 2.

  PMID: 28251836 BACKGROUND

• United Nations. The Sustainable Development Goals Report. 2016. http://www.un.org/sustainabledevelopment/sustainable-development-goals/

  BACKGROUND

• Wedner S, Masanja H, Bowman R, Todd J, Bowman R, Gilbert C. Two strategies for correcting refractive errors in school students in Tanzania: randomised comparison, with implications for screening programmes. Br J Ophthalmol. 2008 Jan;92(1):19-24. doi: 10.1136/bjo.2007.119198.

  PMID: 18156372 BACKGROUND

• Congdon N, Li L, Zhang M, Yang A, Gao Y, Griffiths S, Wu J, Sharma A, Lam DS. Randomized, controlled trial of an educational intervention to promote spectacle use in rural China: the see well to learn well study. Ophthalmology. 2011 Dec;118(12):2343-50. doi: 10.1016/j.ophtha.2011.06.016. Epub 2011 Sep 1.

  PMID: 21889800 BACKGROUND

• Reddy P, Bassett, K. Visual acuity screening in schools: A systematic review of alternate screening methods. Cogent Medicine, 2017. doi:10.1080/2331205X.2017.1371103

  BACKGROUND

• Priya A, Veena K, Thulasiraj R, Fredrick M, Venkatesh R, Sengupta S, Bassett K. Vision screening by teachers in southern Indian schools: testing a new "all class teacher" model. Ophthalmic Epidemiol. 2015 Feb;22(1):60-5. doi: 10.3109/09286586.2014.988877. Epub 2014 Dec 11.

  PMID: 25495755 BACKGROUND

• Yi H, Zhang H, Ma X, Zhang L, Wang X, Jin L, Naidoo K, Minto H, Zou H, Lu L, Rozelle S, Congdon N. Impact of Free Glasses and a Teacher Incentive on Children's Use of Eyeglasses: A Cluster-Randomized Controlled Trial. Am J Ophthalmol. 2015 Nov;160(5):889-896.e1. doi: 10.1016/j.ajo.2015.08.006. Epub 2015 Aug 12.

  PMID: 26275472 BACKGROUND

• Wang X, Congdon N, Ma Y, Hu M, Zhou Y, Liao W, Jin L, Xiao B, Wu X, Ni M, Yi H, Huang Y, Varga B, Zhang H, Cun Y, Li X, Yang L, Liang C, Huang W, Rozelle S, Ma X. Cluster-randomized controlled trial of the effects of free glasses on purchase of children's glasses in China: The PRICE (Potentiating Rural Investment in Children's Eyecare) study. PLoS One. 2017 Nov 21;12(11):e0187808. doi: 10.1371/journal.pone.0187808. eCollection 2017.

  PMID: 29161286 BACKGROUND

• Kolenikov S, Angeles G. Socioeconomic status measurement with discrete proxy variables: Is principal component analysis a reliable answer?. Review of Income and Wealth. 2009 Mar;55(1):128-65

  BACKGROUND

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Nathan Congdon

  Centre for Public Health, Queen's University Belfast

  PRINCIPAL INVESTIGATOR

• Priya Adhisesha Reddy

  Centre for Public Health, Queen's University Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Cluster-randomised, investigator-masked trial. Investigators assessing the components of the main study outcome will be masked to the study group assignment of the school. Staff assessing data for the main outcome will be masked to a child's group assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a cluster randomized trial, with eligible children allocated to the intervention that their school (N=141) was randomized to receive. This will be one of the following three: School Model: Vision screening will be carried out by the vision screeners; refraction will be done at the schools by refractionists, and children who need them will be given free spectacles at the school within two weeks. Referral Model: Vision screening carried out by the vision screeners, and children are referred to nearby Vision Center/ secondary center for refraction and delivery of free spectacles. Teachers will contact families not presenting for follow-up care and for spectacle compliance. Referral Model + Cost Recovery: Vision screening carried out by the vision screeners; children referred to Vision Center for refraction and delivery of spectacles with an option to purchase "upgrade spectacles". Teachers will contact families not presenting for follow-up care and for spectacle compliance.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: August 12, 2019
• Primary Completion: March 21, 2020
• Study Completion: March 30, 2020
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)