Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children (NCT03248336) | Clinical Trial Compass
UnknownNot Applicable
Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children
United States60 participantsStarted 2018-09-02
Plain-language summary
This study is designed to evaluate changes in objective measures of disparity vergence after office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in children 12-17 years old.
Who can participate
Age range9 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* CI Symptom Survey score ≥ 16
* Exophoria at near at least 4 greater than at far
* Receded near point of convergence (NPC) of 6 cm break
* Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion or PFV ≤15 base-out 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 of 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)
* No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study
Exclusion Criteria:
* Constant strabismus at distance or near
* Esophoria of ≥ 2∆ at distance
* Vertical heterophoria ≥ 2∆ at distance or near
* ≥ 2 line interocular difference in best-corrected visual acuity
* Near point of accommodation \>20 cm in either eye as measured by push-up method
* Manifest or latent nystagmus
* History of strabismus surgery or refractive surgery
* 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
What they're measuring
1
Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy