Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency (CITT-ART)
Convergence Insufficiency
About this trial
This is an interventional treatment trial for Convergence Insufficiency focused on measuring convergence insufficiency, vision therapy, reading, attention
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Alabama, Birmingham College of Optometry
- Southern California College of Optometry Marshall B. Ketchum University
- NOVA Southeastern University College of Optometry
- Bascom Palmer Eye Institute
- State University of Optometry College of Optometry
- Akron Children's Hospital
- Ohio State University College of Optometry
- Pennsylvania College of Optometry at Salus University
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Office-based verg/accomm therapy (OBVAT)
Office-based placebo therapy (OBPT)
OBVAT requires a participant to undergo a specific vision therapy regimen with 16 weekly, 60-minute in-office treatment sessions. Vision Therapists (O.D., M.D., Orthoptists, or specially-trained technicians) administer the therapy in the office. OBVAT procedures are then supplemented with various home therapy procedures
Office-based Placebo Therapy (OBPT) requires a participant to undergo a specific therapy regimen of 16 weekly, 60 minute, in-office treatment sessions. Vision therapists (optometrists, ophthalmologists, orthoptists, or specially-trained technicians) administer the therapy in the office. OBPT procedures are then supplemented with placebo home therapy procedures. The procedures for OBPT are designed with the intent of not providing a beneficial training effect on vergence, accommodation, saccadic accuracy, or visual attention beyond normal activities. However, the procedures are designed to simulate real vision therapy in such a way that it will be difficult for participants and parents to know that they have been assigned to the control group and thus are not receiving bonafide OBVAT