Clinical trial NCT03248336: Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children
Official title: Objective Assessment of Disparity Vergence After Treatment of Symptomatic Convergence Insufficiency (CI) in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Convergence Insufficiency
Lead sponsor: Salus University
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Eligible participants received 12 weeks of office vergence/accommodative therapy
Primary purpose: TREATMENT

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 years old.

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 therapy. The primary outcome measure will be the average peak velocity for 4° symmetrical convergence steps. Other objective outcome measures of disparity vergence will be time to peak velocity, latency, and accuracy. Changes in clinical measures \[near point of convergence (NPC), positive fusional vergence at near (PFV)\] and symptoms will be evaluated.

Eligibility criteria: 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

Primary outcomes:
measure: Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy
timeFrame: After 12 weeks of therapy
Secondary outcomes:
measure: Change in time to peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy
timeFrame: After 12 weeks of therapy
measure: Change in latency for 4° symmetrical convergence steps after 12 weeks of therapy
timeFrame: After 12 weeks of therapy
measure: Change in accuracy for 4° symmetrical convergence steps after 12 weeks of therapy
timeFrame: After 12 weeks of therapy
measure: Change in settling time for 4° symmetrical convergence steps after 12 weeks of therapy
timeFrame: After 12 weeks of therapy
measure: Change in the near point of convergence
timeFrame: After 12 weeks of therapy
measure: Change in the positive fusional vergence
timeFrame: After 12 weeks of therapy
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Salus University
state: Pennsylvania
Study officials:
References: