Table 1.
CITT-ART Eligibility and Exclusion Criteria.
Eligibility Criteria |
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Age 9 to 14 years |
Grades 3 through 8 |
CI Symptom Survey (CISS) score ≥ 16 |
Exophoria at near (40 cm) at least 4Δ greater than at far (4 meters) |
Receded near point of convergence of ≥ 6 cm break |
Insufficient positive fusional vergence at near (40 cm) (i.e., failing Sheard’s criterion or positive fusional vergence ≤15Δ base-out break) |
Best-corrected distance (4 meters) and near visual acuity (40cm) of 20/25 or better in each eye |
Random dot stereopsis appreciation of 500 seconds of arc or better (40 cm) |
Willing to wear refractive correction for any of the following uncorrected refractive errors (based on cycloplegic refraction within prior 6 months). (Correction must be worn for at least 2 weeks): – Myopia > −0.75 D spherical equivalent in either eye – Hyperopia > +2.00 D spherical equivalent in either eye – Anisometropia > 0.75 D spherical equivalent – Astigmatism > 1.00 D in either eye • Refractive error corrections adhered to the following guidelines: full hyperopic sphere power or symmetrically reduced by no more than 1.50 D, spherical equivalent myopia and spherical equivalent anisometropia within 0.75 D of full correction; and astigmatism within 0.75 D of full correction and axis within 6 degrees for magnitudes of ≥ 1.00 D. |
Not wearing BI prism or plus add at near for 2 weeks prior to study enrollment and for duration of study |
The timing of enrollment must allow a participant to be attending school at both the baseline and the 16-week outcome examination |
English is primary language spoken at home or child proficient in English as determined by the school |
Parental permission to contact the child’s teacher(s) for study purposes |
Parent and child understand protocol and are willing to accept randomization |
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 |
Exclusion Criteria |
Constant strabismus at distance or near |
Esophoria of ≥ 2Δ at distance |
Vertical heterophoria ≥ 2Δ at distance or near |
≥ 2-line interocular difference in best-corrected distance visual acuity |
Monocular near point of accommodation >20 cm (accommodative amplitude <5D) as measured by push-up method |
Manifest or latent nystagmus |
Word Reading subtest score < 80 on the Wide Range Achievement Test (WRAT-4) |
Kaufman Brief Intelligence Test (KBIT-2) Matrices subtest score <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 such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson disease |
Any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics, bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil) |
Inability to comprehend and/or perform any study-related test or 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 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) |
Household member is an eye care professional, ophthalmic technician, ophthalmology or optometry resident, or optometry student |