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

NCT03248336 | Unknown

• 1 other identifier: HMS1312
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy

  The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and the primary outcome measures will be the change in average peak velocity for 4° symmetrical convergence steps

  After 12 weeks of therapy

Secondary Outcomes (6)

• Change in time to peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy

  After 12 weeks of therapy

• Change in latency for 4° symmetrical convergence steps after 12 weeks of therapy

  After 12 weeks of therapy

• Change in accuracy for 4° symmetrical convergence steps after 12 weeks of therapy

  After 12 weeks of therapy

• Change in settling time for 4° symmetrical convergence steps after 12 weeks of therapy

  After 12 weeks of therapy

• Change in the near point of convergence

  After 12 weeks of therapy

Study Arms (1)

Vision therapy group

EXPERIMENTAL

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

Procedure: office-based vergence/accommodative therapy

Interventions

office-based vergence/accommodative therapy 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.

Also known as: optometric vision therapy

Vision therapy group

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salus University: lead

Study Sites (1)

Salus University

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Central Study Contacts

Mitchell Scheiman, OD, PhD

CONTACT

215-692-0897; scheiman@comcast.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Research

Model Details: Eligible participants received 12 weeks of office vergence/accommodative therapy

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 14, 2017
• Study Start: September 2, 2018
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)