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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248336
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mitchell Scheiman, Salus University

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.

Condition or disease Intervention/treatment Phase
Convergence Insufficiency Procedure: office-based vergence/accommodative therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Eligible participants received 12 weeks of office vergence/accommodative therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Objective Assessment of Disparity Vergence After Treatment of Symptomatic Convergence Insufficiency (CI) in Children
Actual Study Start Date : September 2, 2016
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Arm Intervention/treatment
Experimental: 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
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.
Other Name: optometric vision therapy




Primary Outcome Measures :
  1. Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: 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 :
  1. Change in time to peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: 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

  2. Change in latency for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: 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

  3. Change in accuracy for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: 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

  4. Change in settling time for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: 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

  5. Change in the near point of convergence [ Time Frame: After 12 weeks of therapy ]
    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.

  6. Change in the positive fusional vergence [ Time Frame: After 12 weeks of therapy ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248336


Contacts
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Contact: Mitchell Scheiman, OD, PhD 215-692-0897 scheiman@comcast.net

Locations
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United States, Pennsylvania
Salus University Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Mitchell Scheiman, OD, PhD    215-692-0897    mscheiman@salus.edu   
Sponsors and Collaborators
Salus University
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Responsible Party: Mitchell Scheiman, Dean of Research, Salus University
ClinicalTrials.gov Identifier: NCT03248336    
Other Study ID Numbers: HMS1312
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ocular Motility Disorders
Central Nervous System Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases