Home-based Vision Therapy

Phase 1

Not yet recruiting

• Conditions: Convergence Insufficiency

• Registration Number: NCT06886737
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-28
• Study Start: 2025-10-01
• Primary Completion: 2028-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Simulator Sickness Questionnaire (SSQ)	At completion of active treatment block (six-weeks duration)	This is a standardized questionnaire to test the player's tolerance of the virtual-reality experience.
Vergence Capacity (VR-NPC)	At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)	The near point of convergence (angle of maximum ocular convergence) will be measured using a custom virtual-reality application.
System Usability Scale (SUS)	At completion of active treatment block (six-weeks duration)	This is a standardized questionnaire to assess how easy a new technology is to use.

Secondary Outcome Measures

Name	Time	Method
Accommodation	At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)	Ocular accommodation (focus of the intraocular lens for near viewing) will be measured using the minus-lens method.
Dynamic Vergence	At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)	The accuracy and speed of fixation steps between virtual near and far targets is assessed.
Stereoacuity	At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)	Stereovision is assessed in virtual reality. Stereoacuity threshold is determined from a curve fit to the response data.
VR Word Reading: Word Accuracy Score	At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)	The accuracy and speed of word reading is assessed in response to lists of words presented to the participant in virtual reality. The Word Accuracy Score is the number of words read correctly minus errors.
VR Word Reading: Reading Speed Score	At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)	The accuracy and speed of word reading is assessed in response to lists of words presented to the participant in virtual reality. The Reading Speed Score is the Word Accuracy Score divided by total reading time.
WIAT Word Reading Test: Word Fluency Score	At study onset, At completion of Block 2 (six weeks duration)	Participant reads lists of words and nonsense words. The number of words read correctly within 30 seconds is the fluency score. Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data.
WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Fluency Score	At study onset, At completion of Block 2 (six weeks duration)	Participant reads two passages aloud. The Oral Reading Fluency Score is the Oral Reading Accuracy Score (Outcome #9) divided by the time needed to complete reading of the passage. Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data.
Convergence Insufficiency Symptom Survey (CISS)	At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)	This is a standardized questionnaire to assess symptoms related to near vision.
WIAT Word Reading Tests: Word Accuracy Score	At study onset, At completion of Block 2 (six weeks duration)	Participants read lists of words and nonsense words. The number of words read correctly is the accuracy score. Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data.
WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Accuracy Score	At study onset, At completion of Block 2 (six weeks duration)	Participant reads two passages aloud. The Oral Reading Accuracy Score is the number of words read minus errors (mispronunciations or additions). Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data.

Trial Locations

Locations (1)

Louis Stokes VA Medical Center, Cleveland, OH; 🇺🇸 Cleveland, Ohio, United States