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Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency

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ClinicalTrials.gov Identifier: NCT03593031
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Dr. Tara Lynn Alvarez, New Jersey Institute of Technology

Brief Summary:
Convergence insufficiency (CI) is a prevalent binocular vision disorder with symptoms that include double/blurred vision, eyestrain, and headaches when engaged in reading or other near work. CI is present in 4% of the population where approximately 27% of CI patients do not improve even with validated therapy. The project will quantitatively study changes in convergence eye movements and neural substrates before and after validated therapy in CI patients. This knowledge can lead to improvements in currently validated therapy, reduction in therapy sessions, and reduced healthcare costs.

Condition or disease Intervention/treatment Phase
Convergence Insufficiency Behavioral: Office Based Vergence and Accommodative Therapy Not Applicable

Detailed Description:
Convergence insufficiency (CI), a prevalent binocular vision disorder in adults and children, is characterized by greater exophoria at near than at distance, reduced fusional convergence amplitude, receded near point of convergence, and a reduced accommodative convergence over accommodation ratio (AC/A). CI is associated with symptoms that include double/blurred vision, eyestrain, and headaches when engaged in reading or other near work, thus interfering with activities of daily living. The recent NEI/NIH multi-center randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT), demonstrated the effectiveness of Office-Based Vergence and Accommodative Therapy with home reinforcement (OBVAT) for CI, reporting 73% of patients have sustained improvements of vision function and symptoms. The team published the first fMRI neural substrate data evoked using convergence eye movements in CI patients before and then post-OBVAT. The team's results suggest that with the reduction of visual symptoms, the following were observed: 1) an increase in the percent signal change of functional activity in the frontal eye fields, posterior parietal cortex and the cerebellar vermis, 2) an increase in convergence peak velocity, 3) a decrease in the near point of convergence, 4) an increase in positive fusional amplitude and 5) a reduction in the amount of exophoria at near. The aims of the current proposal are to test the following two hypotheses as potential underlying mechanisms of CI that may be improved post OBVAT: 1) a reduced ability to adapt vergence in near and far space via the 'slow' component of vergence and 2) a reduced ability to quickly diminish disparity error via the 'fast' component of vergence. Not only will our quantitative methods integrated with established CITT standards address important questions about potential mechanisms causing CI, this proposal seeks to identify how a validated vergence therapy may remediate symptoms. This proposal will determine whether either of these two potential mechanisms are causing CI by quantifying the following: 1) rate and magnitude of phoria adaptation, 2) forced vergence fixation disparity curves, 3) peak velocity of convergence eye movements (studying visual cues such as disparity, accommodation and proximal stimuli in isolation and combination), and 4) the functional activity of the fast and slow vergence neural substrates prior to, and then after, OBVAT. The assembled study team is particularly knowledgeable in terms of OBVAT, convergence insufficiency, optometry, vision science, oculomotor research, functional imaging, modeling and statistics with the necessary resources to successfully complete both aims of this study. Results from the project's aims can lead to targeted treatments with improved success rates, potentially reducing the time to remediate symptoms, and ultimately reducing health care costs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Clinician did not know which treatment group. Subjects did not know which treatment group
Primary Purpose: Treatment
Official Title: Functional Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency
Actual Study Start Date : April 1, 2014
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2020

Arm Intervention/treatment
Active Comparator: CI OBVAT
Patients with Convergence Insufficiency in Active Vision Therapy
Behavioral: Office Based Vergence and Accommodative Therapy
Exercises that will stimulate disparity vergence or accommodation independently and then combined will be used.

Sham Comparator: CI Sham therapy
CI Sham therapy
Behavioral: Office Based Vergence and Accommodative Therapy
Exercises that will stimulate disparity vergence or accommodation independently and then combined will be used.

Active Comparator: Controls OBVAT
Control receive active therapy
Behavioral: Office Based Vergence and Accommodative Therapy
Exercises that will stimulate disparity vergence or accommodation independently and then combined will be used.

Sham Comparator: Controls Sham
Subjects with Normal Binocular Vision will receive a therapy that appears to be therapeutic but does not have any binocular coordination benefits.
Behavioral: Office Based Vergence and Accommodative Therapy
Exercises that will stimulate disparity vergence or accommodation independently and then combined will be used.




Primary Outcome Measures :
  1. Disparity Vergence Response Amplitude [ Time Frame: through study completion, an average of 1 year ]
    how accurate a patient can fixate on a new target



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of symptomatic convergence insufficiency binocularly normal control

Exclusion Criteria:

  • history of head trauma any systematic disease that can interfere with vergence or accommodation such as multiple sclerosis

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): NCT03593031


Contacts
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Contact: Tara L Alvarez, PhD 9735965272 tara.l.alvarez@njit.edu
Contact: Elio Santos, PhD elio.santos@njit.edu

Locations
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United States, New Jersey
NJIT Recruiting
Newark, New Jersey, United States, 07102
Contact: Tara Alvarez, PhD    973-596-5272    tara.l.alvarez@njit.edu   
Sponsors and Collaborators
New Jersey Institute of Technology
National Eye Institute (NEI)
Investigators
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Study Director: Atam Dhawan, PhD New Jersey Institute of Technology

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Responsible Party: Dr. Tara Lynn Alvarez, Professor, New Jersey Institute of Technology
ClinicalTrials.gov Identifier: NCT03593031     History of Changes
Other Study ID Numbers: F182-13
R01EY023261 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this time there is no plan in place because the eye movement data collected will be in a proprietary format

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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