Convergence Insufficiency Clinical Trial
— CITT-ARTOfficial title:
Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART)
Verified date | March 2020 |
Source | Salus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9 to <14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to see if office-based therapy for convergence insufficiency (CI) improves reading ability and attention. CI is an eye-teaming problem where the eyes would like to drift outward when reading or doing close work. When eyes drift out, double vision can happen. To prevent double vision one must use extra effort to keep the eyes from going out. This extra effort can cause symptoms that can interfere with reading and working comfortably at near. These symptoms often include eyestrain, blurred vision, headaches, double vision, and loss of place when reading or performing tasks at near. In a prior study we found that therapy improves these symptoms. In this study we are looking at whether the therapy improves reading and attention
Status | Active, not recruiting |
Enrollment | 311 |
Est. completion date | November 2020 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 13 Years |
Eligibility |
Inclusion Criteria: 1. Age 9 to less than 14 years 2. Grades 3 through 8 3. CI Symptom Survey (CISS) score greater or equal to 16 4. Exophoria at near at least 4 prism diopters greater than at far 5. Receded near point of convergence (NPC) of 6 cm or greater break 6. Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's or PFV less than or equal to 15 BO break) 7. Best-corrected distance visual acuity of 20/25 or better in each eye 8. Random dot stereopsis appreciation of 500 seconds of arc or better 9. Wearing appropriate refractive correction (spectacles or contact lenses) for at least 2 weeks prior to final determination of eligibility for any of the following uncorrected refractive errors (based on cycloplegic refraction within prior 12 months) - Myopia greater than -0.75D spherical equivalent (SE) in either eye - Hyperopia greater than +2.00D SE in either eye - SE anisometropia greater than 0.75D - Astigmatism greater than 1.00D in either eye Correction for patients meeting above refractive error criteria must meet the following guidelines: - SE anisometropia must be within 0. 75D of the full anisometropic correction - Astigmatism must be within 0.75D of full correction; axis must be within 6? if astigmatism greater than or equal to 1.00D - For hyperopia, the sphere can be reduced by up to 1.50 D provided reduction is symmetrical - For myopia, the SE must be within 0.75D of the full myopic correction 10. No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study 11. English is primary language spoken at home or child proficient in English as determined by the school 12. Parent does not expect child to start any new ADHD medicine or change the dose of any currently taken ADHD medicine while child is being treated in the study 13. Parental permission to contact the child's teacher(s) for study purposes 14. Parent and child understand protocol and are willing to accept randomization Exclusion Criteria: 1. Constant strabismus at distance or near 2. Esophoria of greater than or equal to 2? at distance 3. Vertical heterophoria greater than or equal to 2? at distance or near 4. greater than or equal to 2 line interocular difference in best-corrected distance visual acuity 5. Monocular near point of accommodation greater than 20 cm (accommodative amplitude less than 5D) in right eye 6. Manifest or latent nystagmus 7. Word Reading subtest score less than 80 on the Wide Range Achievement Test (WRAT-4) 8. Kaufman Brief Intelligence Test (KBIT-2) Matrices subtest score less than 70 9. History of prior strabismus, intraocular, or refractive surgery 10. CI previously treated with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy) 11. CI associated with head trauma or known disease of the brain 12. Diseases known to affect accommodation, vergence, or ocular motility 13. Inability to comprehend and/or perform any study-related test or therapy procedure 14. Speech-language disorder (e.g., stuttering) that would interfere with interpretation of digital recordings of reading tests 15. Significant hearing loss 16. Household member enrolled in present CITT-ART, treated currently, or treated within the past 6 months with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy) 17. Parent or other household member is an eye care professional, ophthalmic technician, ophthalmology or optometry resident, or optometry student |
Country | Name | City | State |
---|---|---|---|
United States | Akron Children's Hospital | Akron | Ohio |
United States | University of Alabama, Birmingham College of Optometry | Birmingham | Alabama |
United States | Ohio State University College of Optometry | Columbus | Ohio |
United States | NOVA Southeastern University College of Optometry | Fort Lauderdale | Florida |
United States | Southern California College of Optometry Marshall B. Ketchum University | Fullerton | California |
United States | Bascom Palmer Eye Institute | Miami | Florida |
United States | State University of Optometry College of Optometry | New York | New York |
United States | Pennsylvania College of Optometry at Salus University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Salus University | Akron Children's Hospital, Bascom Palmer Eye Institute, Marshall B. Ketchum University, National Eye Institute (NEI), Nova Southeastern University, Ohio State University, State University of New York College of Optometry, University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in the Wechsler Individual Achievement Test-III (WIAT-III) reading comprehension score as measured after the completion of 16 weeks of assigned treatment (OBVAT or OBPT). | This test requires the examinee to respond to multiple-choice questions after having read passages independently. | After 16 weeks of treatment | |
Secondary | The change in the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale (SWAN) | The SWAN is a behavior rating scale that has been used for many years as an assessment tool for ADHD. | After 16 weeks of treatment | |
Secondary | Gates-McGintie 4 | The child must respond to multiple-choice questions after having read passages independently | After 16 weeks of treatment | |
Secondary | d2 Test of Attention | The d2 is a timed test of selective and sustained attention.The test measures processing speed, rule compliance, and quality of performance in response to the discrimination of similar stimuli, thereby allowing for an estimation of individual attention and concentration performance | After 16 weeks of treatment | |
Secondary | Academic Behavior Survey (ABS) | The ABS is a 6-item survey designed to measure the frequency of adverse academic behaviors and parental worry about academic performance. | After 16 weeks of treatment | |
Secondary | Curriculum Based Measurement (CBM) | Curriculum Based Measurement is commonly used by educators to assess short-term progress in reading, skills as the child proceeds through the academic year The primary advantage of the CBM measure is the ability to track rate of improvement by initial reading level and by time of year. The addition of the CBM measure will assess reading at each outcome visit and allow us to track changes in a similar manner to attention and CI where we have measures at each outcome visit. In addition, CBM will provide an additional outcome measure for reading using a method that is commonly employed by school districts to monitor reading progress and will help to communicate the clinical significance of our results. | After 16 weeks of treatment |
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