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

Convergence Insufficiency Clinical Trial

Official title:

Objective Assessment of Disparity Vergence After Treatment of Symptomatic Convergence Insufficiency (CI) in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03248336
• Other study ID #: HMS1312
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2020
• Source: Salus University
• Contact: Mitchell Scheiman, OD, PhD
• Phone: 215-692-0897
• Email: scheiman[@]comcast.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Convergence Insufficiency
• Ocular Motility Disorders

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Salus University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Salus University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in time to 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 a secondary outcome measures will be the change in time to peak velocity for 4° symmetrical convergence steps	After 12 weeks of therapy
Secondary	Change in latency 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 a secondary outcome measures will be the change in latency for 4° symmetrical convergence steps	After 12 weeks of therapy
Secondary	Change in accuracy 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 a secondary outcome measures will be the change in accuracy for 4° symmetrical convergence steps	After 12 weeks of therapy
Secondary	Change in settling time 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 a secondary outcome measures will be the change in settling time for 4° symmetrical convergence steps	After 12 weeks of therapy
Secondary	Change in the near point of convergence	The near point of convergence will be measured using the Near Point Rule at baseline and after 12 weeks of therapy. The change in this measurement will a secondary clinical outcome measure.	After 12 weeks of therapy
Secondary	Change in the positive fusional vergence	Positive fusional vergence will be measured using a handheld target placed 40 cm from the participant and using a horizontal prism bar. Positive fusional vergence will be measured at baseline and after 12 weeks of therapy. The change in this measurement will a secondary clinical outcome measure.	After 12 weeks of therapy