Recruiting

Observational Study

Sponsor:

Salus University

Code:

NCT03248336

Conditions

Convergence Insufficiency

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Accepted

Interventions

office-based vergence/accommodative therapy

Study Details

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.

Conditions

Convergence Insufficiency

Study ID

NCT03248336

Start date

Sep 2, 2018

Status verified date

Oct, 2020

Completion date

Dec 1, 2022

Anticipated

Primary completion date

Sep 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vision therapy group

Twelve, 60-minute, weekly visits of office-based vergence/accommodation therapy will be administered by a trained therapist combined with procedures to practice at home (15 minutes, 5 times per week). This treatment sequence is a well-accepted approach for treatment of CI and has been successfully implemented in previous studies. Fifteen minutes of home-based therapy was prescribed to be performed 5 days per week, and compliance with home-based therapy was monitored at each visit by the therapist

Interventions

office-based vergence/accommodative therapy

one -to-one treatment by a trained therapists. The subject is asked to perform 5-6 therapy procedures during a 60 minute therapy session. The subject is also asked to perform 15 minutes per day of home-based therapy.

Primary outcome measure

  • Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: After 12 weeks of therapy ]

Central Contacts and Locations

Central contacts

Mitchell Scheiman, OD, PhD

215-692-0897scheiman@comcast.net

Locations

Salus University

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contacts

Mitchell Scheiman, OD, PhD

215-692-0897mscheiman@salus.edu

More Information

Sponsor

Salus University

Last update posted

Oct 23, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Salus University on 2020-10-23.