Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency

NCT03593031 | Completed

• 2 other identifiers: F182-13R01EY023261
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Convergence Insufficiency

Outcome Measures

Primary Outcomes (1)

• Disparity Vergence Response Amplitude

  how accurate a patient can fixate on a new target

  through study completion, an average of 1 year

Study Arms (4)

CI OBVAT

ACTIVE COMPARATOR

Patients with Convergence Insufficiency in Active Vision Therapy

Behavioral: Office Based Vergence and Accommodative Therapy

CI Sham therapy

SHAM COMPARATOR

CI Sham therapy

Behavioral: Office Based Vergence and Accommodative Therapy

Controls OBVAT

ACTIVE COMPARATOR

Control receive active therapy

Behavioral: Office Based Vergence and Accommodative Therapy

Controls Sham

SHAM COMPARATOR

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

Interventions

Office Based Vergence and Accommodative Therapy BEHAVIORAL

Exercises that will stimulate disparity vergence or accommodation independently and then combined will be used.

CI OBVAT; CI Sham therapy; Controls OBVAT; Controls Sham

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of symptomatic convergence insufficiency binocularly normal control

You may not qualify if:

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

Sponsors & Collaborators

• New Jersey Institute of Technology: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

NJIT

Newark, New Jersey, 07102, United States

Location

Related Publications (5)

• Fine SN, Rutkowski T, Santos EM, Gohel S, Hajebrahimi F, Scheiman M, Alvarez TL. Heath components of objective accommodative responses for convergence insufficiency participants compared with those with binocularly normal vision. Optom Vis Sci. 2025 Dec 1;102(12):731-742. doi: 10.1097/OPX.0000000000002307. Epub 2025 Nov 18.

  PMID: 41252526 DERIVED

• Hajebrahimi F, Sangoi A, Scheiman M, Santos E, Gohel S, Alvarez TL. From convergence insufficiency to functional reorganization: A longitudinal randomized controlled trial of treatment-induced connectivity plasticity. CNS Neurosci Ther. 2024 Aug;30(8):e70007. doi: 10.1111/cns.70007.

  PMID: 39185637 DERIVED

• Hajebrahimi F, Gohel S, Scheiman M, Sangoi A, Iring-Sanchez S, Morales C, Santos EM, Alvarez TL. Altered Large-Scale Resting-State Functional Network Connectivity in Convergence Insufficiency Young Adults Compared With Binocularly Normal Controls. Invest Ophthalmol Vis Sci. 2023 Nov 1;64(14):29. doi: 10.1167/iovs.64.14.29.

  PMID: 37982763 DERIVED

• 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.

  PMID: 33753864 DERIVED

• 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.

  PMID: 31640452 DERIVED

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Atam Dhawan, PhD

  New Jersey Institute of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinician did not know which treatment group. Subjects did not know which treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 19, 2018
• Study Start: April 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)