BREDS: The Baltimore Reading and Eye Disease Study

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT02607384

Collaborator

(none)

328

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error Visual Impairment Convergence Insufficiency Reading Disabilities	Behavioral: Eyeglass wearing Behavioral: Orthoptic exercises Other: Specialist referral	N/A

Detailed 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.

While a number of factors contribute to reading problems, an undiagnosed or untreated ocular condition may present one possible etiology. 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. Little is known about the types of vision problems that affect a grade school population with and without reading difficulty.

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. 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. 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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

328 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A School-based Intervention to Diagnose and Treat Vision Problems in Elementary School Children With Reading Difficulty

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vision problems 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.	Behavioral: Eyeglass wearing Children found to require eyeglasses will be given two pairs free of charge Behavioral: Orthoptic exercises Children found to have convergence insufficiency will be prescribed orthoptic exercises Other: Specialist referral Children found to any other eye condition will be referred to a pediatric eye care specialist

Arm

Intervention/Treatment

Experimental: Vision problems

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.

Behavioral: Eyeglass wearing

Children found to require eyeglasses will be given two pairs free of charge

Behavioral: Orthoptic exercises

Children found to have convergence insufficiency will be prescribed orthoptic exercises

Other: Specialist referral

Children found to any other eye condition will be referred to a pediatric eye care specialist

Outcome Measures

Primary Outcome Measures

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). [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). [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). [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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