Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children

NCT ID: NCT03248336

Last Updated: 2020-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-02
• Study Completion Date: 2022-12-01

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.

Conditions

Convergence Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

office-based vergence/accommodative therapy

Intervention Type: PROCEDURE

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.

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.

Intervention Type: PROCEDURE

Other Intervention Names

optometric vision therapy

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Salus University

OTHER

Sponsor Role: lead

Responsible Party

Mitchell Scheiman

Dean of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Salus University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mitchell Scheiman, OD, PhD

Role: CONTACT

scheiman@comcast.net

215-692-0897

Facility Contacts

Mitchell Scheiman, OD, PhD

Role: primary

mscheiman@salus.edu

215-692-0897

Other Identifiers

HMS1312

Identifier Type: -

Identifier Source: org_study_id