ClinicalTrials.gov
ClinicalTrials.gov Menu

The Baltimore Reading and Eye Disease Study (BREDS)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02607384
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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 : November 2014
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : December 2018


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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02607384


Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: David S Friedman, MD, MPH, PhD Johns Hopkins University

Publications:
Francis DJ, Shaywitz SE, Stuebing KK, Shaywitz BA, & Fletcher, J. M. Developmental lag versus deficit models of reading disability: A longitudinal, individual growth curves analysis. Journal of Educational Psychology 1996; 88:3-17.
Heckman JJ. The case for investing in disadvantaged young children. Investing in our nation's future. First Focus Report 2008; 49-59

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02607384     History of Changes
Other Study ID Numbers: IRB00032063
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Dyslexia
Refractive Errors
Vision Disorders
Vision, Low
Ocular Motility Disorders
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Cranial Nerve Diseases
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Learning Disorders
Neurodevelopmental Disorders
Mental Disorders