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Recruiting NCT06886737

Home-based Vision Therapy

Phase I Interventional Convergence Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual-reality convergence training game.
Who it may be relevant to
Registry conditions: Convergence Insufficiency. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Home-based Treatment of Binocular Eye Dysfunction in Veterans With Traumatic Brain Injury

Overview

Post-concussive vision symptoms affect many Veterans who have experienced traumatic brain injury (TBI). One common issue is trouble with near vision, a problem that may persist long after the acute injury. Double vision or difficulty focusing on close objects can affect reading and depth perception. Poor reading can interfere with academic or work performance, and loss of near focusing can affect jobs that require fine motor tasks like machining and electrical work. Even having trouble using a smartphone can have a substantial impact on both work and social function. Near vision impairment after TBI is not well understood, and treatments are limited. The goal of this project is to investigate novel virtual-reality assessments and training games to improve the near vision diagnosis and home-based rehabilitation. Restoring normal near vision function could have a large impact on the fulfillment of Veterans' educational, career, and overall life goals.

Interventions

  • Other Virtual-reality convergence training game
    The participant plays a custom virtual-reality game that is designed to train convergence.

Primary outcome measures

  • Vergence Capacity (VR-NPC) [Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
  • System Usability Scale (SUS) [Time frame: At completion of active treatment block (six-weeks duration)]
  • Simulator Sickness Questionnaire (SSQ) [Time frame: At completion of active treatment block (six-weeks duration)]
Secondary outcome measures (10)
  • Accommodation [Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
  • Dynamic Vergence [Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
  • Stereoacuity [Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
  • VR Word Reading: Word Accuracy Score [Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
  • VR Word Reading: Reading Speed Score [Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
  • WIAT Word Reading Tests: Word Accuracy Score [Time frame: At study onset, At completion of Block 2 (six weeks duration)]
  • WIAT Word Reading Test: Word Fluency Score [Time frame: At study onset, At completion of Block 2 (six weeks duration)]
  • WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Accuracy Score [Time frame: At study onset, At completion of Block 2 (six weeks duration)]
  • WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Fluency Score [Time frame: At study onset, At completion of Block 2 (six weeks duration)]
  • Convergence Insufficiency Symptom Survey (CISS) [Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]

Eligibility criteria

Inclusion criteria

  • U.S. Military Veteran
  • Place of residence within driving distance of Cleveland, OH
  • Clinical eye exam within 6 months prior to enrollment and since the most recent TBI (if applicable) and the onset of near vision symptoms (if applicable)
  • Best-corrected visual acuity 20/25 or better in each eye
  • Convergence insufficiency (VR-NPC < 32 deg)

Exclusion criteria

  • Neurological condition other than TBI that would affect convergence
  • History of strabismus, amblyopia, or other binocular vision issues prior to TBI

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Louis Stokes VA Medical Center, Cleveland, OH — Cleveland

Identifiers

NCT: NCT06886737 · N5317-R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗