Status:
UNKNOWN
Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children
Lead Sponsor:
Salus University
Conditions:
Convergence Insufficiency
Eligibility:
All Genders
9-17 years
Phase:
NA
Brief 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 ye...
Detailed Description
30 participants with normal binocular vision and 30 with CI will be recruited for this prospective study. All participants with CI will be treated with 12 weeks of office-based vergence/accommodative ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03248336
Start Date
September 2 2018
End Date
December 1 2022
Last Update
October 23 2020
Active Locations (1)
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1
Salus University
Philadelphia, Pennsylvania, United States, 19141