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Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency

Primary Purpose

Convergence Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Office Based Vergence and Accommodative Therapy
Sponsored by
New Jersey Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Convergence Insufficiency

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NJIT

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

CI OBVAT

CI Sham therapy

Controls OBVAT

Controls Sham

Arm Description

Patients with Convergence Insufficiency in Active Vision Therapy

CI Sham therapy

Control receive active therapy

Subjects with Normal Binocular Vision will receive a therapy that appears to be therapeutic but does not have any binocular coordination benefits.

Outcomes

Primary Outcome Measures

Disparity Vergence Response Amplitude
how accurate a patient can fixate on a new target

Secondary Outcome Measures

Full Information

First Posted
July 6, 2018
Last Updated
February 24, 2020
Sponsor
New Jersey Institute of Technology
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT03593031
Brief Title
Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency
Official Title
Functional Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New Jersey Institute of Technology
Collaborators
National Eye Institute (NEI)

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
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.
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.

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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Clinician did not know which treatment group. Subjects did not know which treatment group
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CI OBVAT
Arm Type
Active Comparator
Arm Description
Patients with Convergence Insufficiency in Active Vision Therapy
Arm Title
CI Sham therapy
Arm Type
Sham Comparator
Arm Description
CI Sham therapy
Arm Title
Controls OBVAT
Arm Type
Active Comparator
Arm Description
Control receive active therapy
Arm Title
Controls Sham
Arm Type
Sham Comparator
Arm Description
Subjects with Normal Binocular Vision will receive a therapy that appears to be therapeutic but does not have any binocular coordination benefits.
Intervention Type
Behavioral
Intervention Name(s)
Office Based Vergence and Accommodative Therapy
Intervention Description
Exercises that will stimulate disparity vergence or accommodation independently and then combined will be used.
Primary Outcome Measure Information:
Title
Disparity Vergence Response Amplitude
Description
how accurate a patient can fixate on a new target
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atam Dhawan, PhD
Organizational Affiliation
New Jersey Institute of Technology
Official's Role
Study Director
Facility Information:
Facility Name
NJIT
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At this time there is no plan in place because the eye movement data collected will be in a proprietary format
Citations:
PubMed Identifier
33753864
Citation
Alvarez TL, Scheiman M, Morales C, Gohel S, Sangoi A, Santos EM, Yaramothu C, d'Antonio-Bertagnolli JV, Li X, Biswal BB. Underlying neurological mechanisms associated with symptomatic convergence insufficiency. Sci Rep. 2021 Mar 22;11(1):6545. doi: 10.1038/s41598-021-86171-9.
Results Reference
derived
PubMed Identifier
31640452
Citation
Alvarez TL, Scheiman M, Santos EM, Morales C, Yaramothu C, D'Antonio-Bertagnolli JV, Biswal BB, Gohel S, Li X. The Convergence Insufficiency Neuro-mechanism in Adult Population Study (CINAPS) Randomized Clinical Trial: Design, Methods, and Clinical Data. Ophthalmic Epidemiol. 2020 Feb;27(1):52-72. doi: 10.1080/09286586.2019.1679192. Epub 2019 Oct 22.
Results Reference
derived

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Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency

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