The Baltimore Reading and Eye Disease Study

NCT02607384 | Completed

• 1 other identifier: IRB00032063
• Study Type: interventional
• Target: 328
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error; Visual Impairment; Convergence Insufficiency; Reading Disabilities

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Vision problems

EXPERIMENTAL

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; Behavioral: Orthoptic exercises; Other: Specialist referral

Interventions

Eyeglass wearing BEHAVIORAL

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

Vision problems

Orthoptic exercises BEHAVIORAL

Children found to have convergence insufficiency will be prescribed orthoptic exercises

Vision problems

Specialist referral OTHER

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

Vision problems

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically and cognitively capable of completing a reading test and eye examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (14)

• 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.

  BACKGROUND

• 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.

  PMID: 21357342 BACKGROUND

• 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.

  PMID: 19243832 BACKGROUND

• 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.

  PMID: 18538407 BACKGROUND

• 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.

  PMID: 15665167 BACKGROUND

• 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.

  PMID: 16170125 BACKGROUND

• 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.

  PMID: 19328012 BACKGROUND

• 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.

  PMID: 21596289 BACKGROUND

• Levine MD. Reading disability: do the eyes have it? Pediatrics. 1984 Jun;73(6):869-70. No abstract available.

  PMID: 6728588 BACKGROUND

• Lubkin V. The ophthalmologist and the reading problem. Bull N Y Acad Med. 1968 Apr;44(4):459-69. No abstract available.

  PMID: 5241254 BACKGROUND

• 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.

  PMID: 21835034 BACKGROUND

• 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.

  PMID: 22080400 BACKGROUND

• Heckman JJ. The case for investing in disadvantaged young children. Investing in our nation's future. First Focus Report 2008; 49-59

  BACKGROUND

• 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.

  PMID: 31112777 DERIVED

MeSH Terms

Conditions

Refractive Errors; Vision Disorders; Ocular Motility Disorders; Dyslexia

Condition Hierarchy (Ancestors)

Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Cranial Nerve Diseases; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Specific Learning Disorder; Learning Disabilities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• David S Friedman, MD, MPH, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Megan E Collins, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 18, 2015
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: November 12, 2019

Record last verified: 2019-11