Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency

Functional Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency

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.

Study Overview

• Status: Completed
• Conditions: Convergence Insufficiency
• Intervention / Treatment: Behavioral: Office Based Vergence and Accommodative Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • NJIT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disparity Vergence Response Amplitude	how accurate a patient can fixate on a new target	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: New Jersey Institute of Technology
• Collaborators: National Eye Institute (NEI)
• Investigators: Study Director: Atam Dhawan, PhD, New Jersey Institute of Technology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders
• Other Study ID Numbers: F182-13; R01EY023261 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: At this time there is no plan in place because the eye movement data collected will be in a proprietary format

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No