search
Back to results

The Baltimore Reading and Eye Disease Study (BREDS)

Primary Purpose

Refractive Error, Visual Impairment, Convergence Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Eyeglass wearing
Orthoptic exercises
Specialist referral
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Refractive Error

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Vision problems

    Arm Description

    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.

    Outcomes

    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).
    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).
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    November 12, 2015
    Last Updated
    November 7, 2019
    Sponsor
    Johns Hopkins University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02607384
    Brief Title
    The Baltimore Reading and Eye Disease Study
    Acronym
    BREDS
    Official Title
    A School-based Intervention to Diagnose and Treat Vision Problems in Elementary School Children With Reading Difficulty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractive Error, Visual Impairment, Convergence Insufficiency, Reading Disabilities

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    328 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vision problems
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Eyeglass wearing
    Intervention Description
    Children found to require eyeglasses will be given two pairs free of charge
    Intervention Type
    Behavioral
    Intervention Name(s)
    Orthoptic exercises
    Intervention Description
    Children found to have convergence insufficiency will be prescribed orthoptic exercises
    Intervention Type
    Other
    Intervention Name(s)
    Specialist referral
    Intervention Description
    Children found to any other eye condition will be referred to a pediatric eye care specialist
    Primary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David S Friedman, MD, MPH, PhD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Megan E Collins, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21357342
    Citation
    Handler SM, Fierson WM, Section on Ophthalmology; Council on Children with Disabilities; American Academy of Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; American Association of Certified Orthoptists. Learning disabilities, dyslexia, and vision. Pediatrics. 2011 Mar;127(3):e818-56. doi: 10.1542/peds.2010-3670. Epub 2011 Feb 28.
    Results Reference
    background
    PubMed Identifier
    19243832
    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.
    Results Reference
    background
    PubMed Identifier
    18538407
    Citation
    Friedman DS, Repka MX, Katz J, Giordano L, Ibironke J, Hawes P, Burkom D, Tielsch JM. Prevalence of decreased visual acuity among preschool-aged children in an American urban population: the Baltimore Pediatric Eye Disease Study, methods, and results. Ophthalmology. 2008 Oct;115(10):1786-95, 1795.e1-4. doi: 10.1016/j.ophtha.2008.04.006. Epub 2008 Jun 5.
    Results Reference
    background
    PubMed Identifier
    15665167
    Citation
    Williams WR, Latif AH, Hannington L, Watkins DR. Hyperopia and educational attainment in a primary school cohort. Arch Dis Child. 2005 Feb;90(2):150-3. doi: 10.1136/adc.2003.046755.
    Results Reference
    background
    PubMed Identifier
    16170125
    Citation
    Stifter E, Burggasser G, Hirmann E, Thaler A, Radner W. Monocular and binocular reading performance in children with microstrabismic amblyopia. Br J Ophthalmol. 2005 Oct;89(10):1324-9. doi: 10.1136/bjo.2005.066688.
    Results Reference
    background
    PubMed Identifier
    19328012
    Citation
    Butler BC, Klein R. Inattentional blindness for ignored words: comparison of explicit and implicit memory tasks. Conscious Cogn. 2009 Sep;18(3):811-9. doi: 10.1016/j.concog.2009.02.009. Epub 2009 Mar 26.
    Results Reference
    background
    PubMed Identifier
    21596289
    Citation
    Granet DB. Learning disabilities, dyslexia, and vision: The role of the pediatric ophthalmologist. J AAPOS. 2011 Apr;15(2):119-20. doi: 10.1016/j.jaapos.2011.03.003. No abstract available.
    Results Reference
    background
    PubMed Identifier
    6728588
    Citation
    Levine MD. Reading disability: do the eyes have it? Pediatrics. 1984 Jun;73(6):869-70. No abstract available.
    Results Reference
    background
    PubMed Identifier
    5241254
    Citation
    Lubkin V. The ophthalmologist and the reading problem. Bull N Y Acad Med. 1968 Apr;44(4):459-69. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21835034
    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.
    Results Reference
    background
    PubMed Identifier
    22080400
    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.
    Results Reference
    background
    Citation
    Heckman JJ. The case for investing in disadvantaged young children. Investing in our nation's future. First Focus Report 2008; 49-59
    Results Reference
    background
    PubMed Identifier
    31112777
    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.
    Results Reference
    derived

    Learn more about this trial

    The Baltimore Reading and Eye Disease Study

    We'll reach out to this number within 24 hrs