Status:
UNKNOWN
Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency
Lead Sponsor:
Salus University
Collaborating Sponsors:
National Eye Institute (NEI)
Marshall B. Ketchum University
Conditions:
Convergence Insufficiency
Eligibility:
All Genders
9-13 years
Phase:
PHASE3
Brief Summary
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 offi...
Detailed Description
Following the success of the NEI-funded Convergence Insufficiency Treatment Trials (CITT), the next logical and important research issue is to determine if the successful treatment of symptomatic conv...
Eligibility Criteria
Inclusion
- Age 9 to less than 14 years
- Grades 3 through 8
- CI Symptom Survey (CISS) score greater or equal to 16
- Exophoria at near at least 4 prism diopters greater than at far
- Receded near point of convergence (NPC) of 6 cm or greater break
- Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's or PFV less than or equal to 15 BO break)
- Best-corrected distance visual acuity of 20/25 or better in each eye
- Random dot stereopsis appreciation of 500 seconds of arc or better
- 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
- No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study
- English is primary language spoken at home or child proficient in English as determined by the school
- 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
- Parental permission to contact the child's teacher(s) for study purposes
- Parent and child understand protocol and are willing to accept randomization
Exclusion
- Constant strabismus at distance or near
- Esophoria of greater than or equal to 2∆ at distance
- Vertical heterophoria greater than or equal to 2∆ at distance or near
- greater than or equal to 2 line interocular difference in best-corrected distance visual acuity
- Monocular near point of accommodation greater than 20 cm (accommodative amplitude less than 5D) in right eye
- Manifest or latent nystagmus
- Word Reading subtest score less than 80 on the Wide Range Achievement Test (WRAT-4)
- Kaufman Brief Intelligence Test (KBIT-2) Matrices subtest score less than 70
- History of prior strabismus, intraocular, or refractive surgery
- CI previously treated with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy)
- CI associated with head trauma or known disease of the brain
- Diseases known to affect accommodation, vergence, or ocular motility
- Inability to comprehend and/or perform any study-related test or therapy procedure
- Speech-language disorder (e.g., stuttering) that would interfere with interpretation of digital recordings of reading tests
- Significant hearing loss
- 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)
- Parent or other household member is an eye care professional, ophthalmic technician, ophthalmology or optometry resident, or optometry student
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT02207517
Start Date
May 1 2014
End Date
November 1 2020
Last Update
March 17 2020
Active Locations (8)
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1
University of Alabama, Birmingham College of Optometry
Birmingham, Alabama, United States, 35294
2
Southern California College of Optometry Marshall B. Ketchum University
Fullerton, California, United States, 90037
3
NOVA Southeastern University College of Optometry
Fort Lauderdale, Florida, United States, 33314
4
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136