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

Primary Purpose

Convergence Insufficiency

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

office-based vergence/accommodative therapy

About this trial

This is an interventional treatment trial for Convergence Insufficiency

Eligibility Criteria

9 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Salus UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vision therapy group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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.

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.

Full Information

NCT ID

NCT03248336

First Posted

August 7, 2017

Last Updated

October 22, 2020

Sponsor

Salus University

1. Study Identification

Unique Protocol Identification Number

NCT03248336

Brief Title

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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2, 2018 (Actual)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Salus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Convergence Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Eligible participants received 12 weeks of office vergence/accommodative therapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vision therapy group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

office-based vergence/accommodative therapy

Other Intervention Name(s)

optometric vision therapy

Intervention Description

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 Information:

Title

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

Description

Time Frame

After 12 weeks of therapy

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

After 12 weeks of therapy

Title

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

Description

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

Time Frame

After 12 weeks of therapy

Title

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

Description

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

Time Frame

After 12 weeks of therapy

Title

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

Description

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

Time Frame

After 12 weeks of therapy

Title

Change in the near point of convergence

Description

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.

Time Frame

After 12 weeks of therapy

Title

Change in the positive fusional vergence

Description

Time Frame

After 12 weeks of therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mitchell Scheiman, OD, PhD

Phone

215-692-0897

scheiman@comcast.net

Facility Information:

Facility Name

Salus University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19141

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mitchell Scheiman, OD, PhD

Phone

215-692-0897

mscheiman@salus.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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