Overview

This trial is active, not recruiting.

Conditions refractive error, visual impairment, convergence insufficiency, reading disabilities
Treatments eyeglass wearing, orthoptic exercises, specialist referral
Sponsor Johns Hopkins University
Start date November 2014
End date July 2016
Trial size 400 participants
Trial identifier NCT02607384, IRB00032063

Summary

The Baltimore Reading and Eye Disease Study (BREDS) is a two year study to determine the prevalence of vision problems in an early school age population with reading difficulty. Comprehensive vision and reading tests will be administered to 400 students at participating schools in the Baltimore City Public School system.

A secondary goal is to examine the impact of vision treatment on reading performance. Children with refractive error or convergence insufficiency will be provided treatment free of charge. The investigators will evaluate the impact that the treatment has on vision function and reading performance.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Children with refractive error will be prescribed eyeglass wearing, and children with convergence insufficiency will be given orthoptic exercises. Children with any other vision problem will be given a specialist referral to a pediatric eye specialist.
eyeglass wearing
Children found to require eyeglasses will be given two pairs free of charge
orthoptic exercises
Children found to have convergence insufficiency will be prescribed orthoptic exercises
specialist referral
Children found to any other eye condition will be referred to a pediatric eye care specialist

Primary Outcomes

Measure
Prevalence of refractive error and convergence insufficiency among students who perform poorly on reading tests as measured by the Woodcock-Johnson III Tests of Achievement and Gray Oral Reading Test 4 (GORT-4).
time frame: 1 year
Association between refractive error and convergence insufficiency and reading ability as measured by the Woodcock-Johnson III Tests of Achievement and Gray Oral Reading Test 4 (GORT-4).
time frame: 2 years
Effect of correction of refractive error and orthoptic exercises on reading ability as measured by the Woodcock-Johnson III Tests of Achievement and Gray Oral Reading Test 4 (GORT-4).
time frame: 2 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Medically and cognitively capable of completing a reading test and eye examination Exclusion Criteria: - Limited English proficiency (as categorized by the school district) - Severe cognitive delay that limits ability to complete a written examination - Ocular condition that has resulted in severe, irreversible visual impairment - Medical/ neurological co-morbidities causing significant cognitive delay or cortical visual impairment

Additional Information

Official title A School-based Intervention to Diagnose and Treat Vision Problems in Elementary School Children With Reading Difficulty
Principal investigator David S Friedman, MD, MPH, PhD
Description Learning to read is a fundamental skill taught in the early years of elementary school education. Students who experience difficulty reading are at risk for long-term struggles with academic achievement. In fact, achieving reading proficiency by the end of third grade has been established as key predictor of life success [Francis 1996]. While a number of factors contribute to reading problems, an undiagnosed or untreated ocular condition may present one possible etiology [Handler 2011]. To the investigator's knowledge, there are no large scale or prospective studies evaluating the prevalence of vision disorders in children with reading difficulties. Previously, the Baltimore Pediatric Eye Disease Study performed visual assessments in the Baltimore area for children 6 months through 5 years of age to establish the prevalence of select ocular disorders in this pre-school population [Giordano 2009, Friedman 2008]. Little is known about the types of vision problems that affect a grade school population with and without reading difficulty [Williams 2005, Stifter 2005]. There is general consensus that undiagnosed or untreated vision problems may contribute to reading difficulty, although the extent to which treatment will improve reading performance is not well established [Kiely 2001, Granet 2011, Levine 1984, Lubkin 1968]. Although there are some studies demonstrating that treatment of vision problems can improve reading performance, publications on the efficacy of school-based interventions to identify and treat vision problems in school-age children are lacking [Dusek 2011,Borsting 2012]. If successful, a school-based intervention could have significant impact improving reading performance, especially in high poverty neighborhoods where children have the highest risk of poor reading aptitude and limited access to eye care services [Heckman 2008]. The primary goal of this research study is to determine the prevalence of vision problems in an early school age population with reading difficulty. To adequately address this question, the investigators will administer reading and vision assessments to 400 second and third graders in participating schools within the Baltimore City Public School system. In addition, the investigators will obtain information on how many children with vision problems have received treatment in the past, and if not, why not. The investigators will also determine how schools handle and refer children who are felt to be poor readers in order to assist with planning future interventions. This study will be conducted over a two-year period. In the first year, the investigators conducted baseline vision and reading assessment on all participating subjects. In the second year, the investigators will conduct follow up vision and reading assessments on all children treated with eyeglasses or eye exercises and a subset of subjects with healthy eye exams. The investigators plan to evaluate any barriers to interventions, and where possible assist in overcoming such barriers, for example by replacing lost/broken eyeglasses. A secondary goal is to examine the impact of vision treatment on reading performance. Children with refractive error and convergence insufficiency will be provided treatment free of charge. The investigators will evaluate the impact that the treatment has on vision function and reading performance. In subsequent phases of this project, the investigators also hope to learn how novel treatments (e.g. iPads) impact reading performance.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.