Clinical trial NCT02607384: The Baltimore Reading and Eye Disease Study
Official title: A School-based Intervention to Diagnose and Treat Vision Problems in Elementary School Children With Reading Difficulty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Visual Impairment
Convergence Insufficiency
Reading Disabilities
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 328
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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

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).
timeFrame: 1 year
measure: 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).
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: David S Friedman, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Megan E Collins, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Giordano L, Friedman DS, Repka MX, Katz J, Ibironke J, Hawes P, Tielsch JM. Prevalence of refractive error among preschool children in an urban population: the Baltimore Pediatric Eye Disease Study. Ophthalmology. 2009 Apr;116(4):739-46, 746.e1-4. doi: 10.1016/j.ophtha.2008.12.030. Epub 2009 Feb 25.
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citation: Dusek WA, Pierscionek BK, McClelland JF. An evaluation of clinical treatment of convergence insufficiency for children with reading difficulties. BMC Ophthalmol. 2011 Aug 11;11:21. doi: 10.1186/1471-2415-11-21.
citation: Borsting E, Mitchell GL, Kulp MT, Scheiman M, Amster DM, Cotter S, Coulter RA, Fecho G, Gallaway MF, Granet D, Hertle R, Rodena J, Yamada T; CITT Study Group. Improvement in academic behaviors after successful treatment of convergence insufficiency. Optom Vis Sci. 2012 Jan;89(1):12-8. doi: 10.1097/OPX.0b013e318238ffc3.
citation: Heckman JJ. The case for investing in disadvantaged young children. Investing in our nation's future. First Focus Report 2008; 49-59
citation: Huang AH, Guo X, Mudie LI, Wolf R, Owoeye J, Repka MX, Friedman DS, Slavin RE, Collins ME. Baltimore Reading and Eye Disease Study (BREDS): compliance and satisfaction with glasses usage. J AAPOS. 2019 Aug;23(4):207.e1-207.e6. doi: 10.1016/j.jaapos.2019.01.018. Epub 2019 May 18.