Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perfecting Refraction in India With Superior Service Models (PRISSM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03983278
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborators:
Aravind Eye Care System
PBMA’s H.V. Desai Eye Hospital, Pune
Sadguru Netra Chikitsalaya, Post Graduate Institute Of Ophthalmology (New SNC)
Orbis
Padmashree Dr. D. Y. Patil Medical College
Information provided by (Responsible Party):
Congdon Nathan, Queen's University, Belfast

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 Model" 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 3 months 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.

Condition or disease Intervention/treatment Phase
Refractive Error Other: School Model Other: Referral Model Other: Referral Model + Cost Recovery Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Single (Investigator)
Masking Description:

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.

Primary Purpose: Health Services Research
Official Title: 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: School Model
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
Free delivery of glasses at the school within two weeks after screening

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

Experimental: Referral Model + Cost Recovery
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
After the screening children referred to Vision Center for refraction and delivery of free glasses with the option to purchase "upgrade glasses"




Primary Outcome Measures :
  1. Program cost-effectiveness [ Time Frame: 13 months ]
    Program cost per child identified with correctable refractive error, who receives spectacles and wears them at an un-announced visit 3 month 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.


Secondary Outcome Measures :
  1. Proportion of children receiving spectacles who are wearing them at the time of un-announced 3-month follow-up [ Time Frame: 12 months ]
    Proportion of children receiving spectacles who are wearing them at the time of un-announced 3-month follow-up

  2. Purchase rates of upgrade spectacles in the Referral + Cost Recovery Group [ Time Frame: 12 months ]
    Purchase rates of upgrade spectacles in the Referral + Cost Recovery Group

  3. Teacher and student reports of rates of teacher interventions in the two Referral groups [ Time Frame: 12 months ]
    Teacher and student reports of rates of teacher interventions in the two Referral groups (contact of parents to complete referral, encouraging children to wear spectacles)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983278


Contacts
Layout table for location contacts
Contact: Priya Adhisesha Reddy +919443727302 priyaadhi.reddy@gmail.com
Contact: Parikshit Gogate parikshitgogate@hotmail.com

Sponsors and Collaborators
Sun Yat-sen University
Aravind Eye Care System
PBMA’s H.V. Desai Eye Hospital, Pune
Sadguru Netra Chikitsalaya, Post Graduate Institute Of Ophthalmology (New SNC)
Orbis
Padmashree Dr. D. Y. Patil Medical College
Investigators
Layout table for investigator information
Principal Investigator: Nathan Congdon Centre for Public Health, Queen's University Belfast
Principal Investigator: Priya Adhisesha Reddy Centre for Public Health, Queen's University Belfast

Publications of Results:
How many children are there in India? http://www.childlineindia.org.in/child-in-india.htm
8. United Nations. The Sustainable Development Goals Report. 2016. http://www.un.org/sustainabledevelopment/sustainable-development-goals/
11. 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
15. 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

Other Publications:
Gogate P et al. Spectacle compliance in secondary school children in rural Pune district. Ind J Ophthalmol 2013;61:6-11

Layout table for additonal information
Responsible Party: Congdon Nathan, Professor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT03983278     History of Changes
Other Study ID Numbers: PRISSM (19.09v3)
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Congdon Nathan, Queen's University, Belfast:
Child
Refractive Error
Myopia
School screening
Cost effectiveness
India

Additional relevant MeSH terms:
Layout table for MeSH terms
Refractive Errors
Eye Diseases