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
About this trial
This is an interventional other trial for Refractive Error
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
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
NCT ID
NCT02607384
First Posted
November 12, 2015
Last Updated
November 7, 2019
Sponsor
Johns Hopkins University
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
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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
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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
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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
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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
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Citation
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Results Reference
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PubMed Identifier
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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
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The Baltimore Reading and Eye Disease Study
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