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
Sponsored by
About this trial
This is an interventional treatment trial for Convergence Insufficiency
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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
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
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
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
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.
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
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
Email
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
Email
mscheiman@salus.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children
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