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Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI

NCT06848673 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-27

No results posted yet for this study

Summary

The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of office-based vergence/accommodative therapy with movement (OBVAM) for mTBI-related convergence insufficiency.

Conditions

  • Convergence Insufficiency

Interventions

OTHER

Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. Additional details are provided in the Overall Program Narrative. Participants undergoing office-based VAM therapy will be prescribed home therapy procedures including the HTS2 Home Vision Therapy System (https://htsvision.com/) thrice weekly to support their in-office VAM therapy. This software progressively increases fusional convergence and divergence demands, offers instant user feedback, and will allow us to track participants' usage and progress. Basic procedures like free-space fusion cards and Brock String will also be prescribed for home therapy.

Sponsors & Collaborators

  • Salus University

    lead OTHER

Principal Investigators

  • Mitchell Scheiman, OD, PhD · Drexel University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2028-04-30
Completion
2028-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06848673 on ClinicalTrials.gov