Refractive ErrorBREDSNCT02607384
The Baltimore Reading and Eye Disease Study
A study testing Eyeglass wearing, Orthoptic exercises and Specialist referral in people with Refractive Error and Visual Impairment, run by Johns Hopkins University.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Refractive Error, Visual Impairment, Convergence Insufficiency
- What is being tested?
- Eyeglass wearing, Orthoptic exercises and Specialist referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medically and cognitively capable of completing a reading test and eye examination
Who cannot join
- 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
About this study
Official title: A School-based Intervention to Diagnose and Treat Vision Problems in Elementary School Children With Reading Difficulty
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.
Read the 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.
- Being tested
- Eyeglass wearing, Orthoptic exercises, Specialist referral
- Medical subject headings
- Refractive Errors, Vision Disorders, Ocular Motility Disorders, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyeglass wearingBehavioural
Children found to require eyeglasses will be given two pairs free of charge
Orthoptic exercisesBehavioural
Children found to have convergence insufficiency will be prescribed orthoptic exercises
Specialist referralOther
Children found to any other eye condition will be referred to a pediatric eye care specialist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Eyeglass wearing; Behavioral: Orthoptic exercises; Other: Specialist referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S Friedman, MD, MPH, PhD, Principal investigator, Johns Hopkins UniversityMegan E Collins, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607384
- Sponsor's protocol ID
- IRB00032063
- Acronym
- BREDS
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2015
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
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.
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.
PubMed 21357342Giordano 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.
PubMed 19243832Friedman 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.
PubMed 18538407Williams 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.
PubMed 15665167Stifter 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.
PubMed 16170125Butler 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.
PubMed 19328012Granet 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.
PubMed 21596289Levine MD. Reading disability: do the eyes have it? Pediatrics. 1984 Jun;73(6):869-70. No abstract available.
PubMed 6728588Lubkin V. The ophthalmologist and the reading problem. Bull N Y Acad Med. 1968 Apr;44(4):459-69. No abstract available.
PubMed 5241254Dusek 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.
PubMed 21835034Borsting 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.
PubMed 22080400Heckman JJ. The case for investing in disadvantaged young children. Investing in our nation's future. First Focus Report 2008; 49-59
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.
PubMed 31112777
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-based Intervention to Diagnose and Treat Vision Problems in Elementary School Children With Reading Difficulty
- ClinicalTrials.gov ID
- NCT02607384
- Acronym / sponsor ID
- BREDS / IRB00032063
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vision problems | Experimental | Behavioral: Eyeglass wearing, Behavioral: Orthoptic exercises, Other: Specialist referralChildren 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medically and cognitively capable of completing a reading test and eye examination
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eyeglass wearingChildren found to require eyeglasses will be given two pairs free of charge | Behavioural | Vision problems |
| Orthoptic exercisesChildren found to have convergence insufficiency will be prescribed orthoptic exercises | Behavioural | Vision problems |
| Specialist referralChildren found to any other eye condition will be referred to a pediatric eye care specialist | Other | Vision problems |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- BackgroundFrancis 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: PubMed 21357342Handler 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.
- Background: PubMed 19243832Giordano 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.
- Background: PubMed 18538407Friedman 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.
- Background: PubMed 15665167Williams 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.
- Background: PubMed 16170125Stifter 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.
- Background: PubMed 19328012Butler 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.
- Background: PubMed 21596289Granet 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.
- Background: PubMed 6728588Levine MD. Reading disability: do the eyes have it? Pediatrics. 1984 Jun;73(6):869-70. No abstract available.
- Background: PubMed 5241254Lubkin V. The ophthalmologist and the reading problem. Bull N Y Acad Med. 1968 Apr;44(4):459-69. No abstract available.
- Background: PubMed 21835034Dusek 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.
- Background: PubMed 22080400Borsting 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Friedman, MD, MPH, PhD principal investigator
Johns Hopkins University
Megan E Collins, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Eyeglass wearing, Orthoptic exercises and Specialist referral in people with Refractive Error and Visual Impairment, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02607384, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.