Vision Therapy for Convergence Insufficiency

Overseen By Mark F Walker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological conditions, Strabismus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

45 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Virtual-reality convergence training game for Convergence Insufficiency?

Research suggests that using virtual reality games for vision training can help treat convergence insufficiency by making the exercises more engaging, which may improve patient compliance and lead to better outcomes. ^{1 2 3 4 5}

Is vision therapy for convergence insufficiency safe?

The research does not provide specific safety data for vision therapy using virtual reality or other methods for convergence insufficiency, but it does mention that compliance with treatment can be an issue, suggesting that the therapy is generally safe but may require consistent participation to be effective. ^{1 2 3 4 5}

How is the virtual-reality convergence training game treatment different from other treatments for convergence insufficiency?

The virtual-reality convergence training game is unique because it uses gamification to make vision therapy more engaging, which can improve patient compliance compared to traditional treatments. This approach leverages virtual reality to create an interactive and immersive experience, potentially making it more effective and enjoyable for patients. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Mark F. Walker, MD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Eligibility Criteria

This trial is for Veterans who have experienced traumatic brain injury (TBI) and are struggling with near vision problems like double vision or difficulty focusing on close objects, which can impact reading and depth perception.

Inclusion Criteria

Best-corrected visual acuity 20/25 or better in each eye

Convergence insufficiency (VR-NPC < 32 deg)

Place of residence within driving distance of Cleveland, OH

Exclusion Criteria

I have a neurological condition affecting my eye movement.

I had vision problems like crossed eyes or lazy eye before a brain injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Block

Participants undergo virtual-reality assessments and training games to improve near vision

6 weeks

At study onset, At completion of Block 1

Non-Intervention Block

Participants do not receive active treatment during this period

6 weeks

At completion of Block 2

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Virtual-reality convergence training game

Trial Overview The study is testing a virtual-reality convergence training game designed to improve near vision diagnosis and rehabilitation at home. It aims to help those with post-concussive vision symptoms restore normal function in their near vision.

Participant Groups

Group I: Group B Experimental Treatment 1 Intervention

Non-intervention block followed by intervention block

Group II: Group A Experimental Treatment 1 Intervention

Intervention block followed by non-intervention block

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A study involving 42 young adults showed that playing a fast-paced virtual reality game for 25 minutes significantly improved binocular accommodative facilities by an average of 4.67 cycles per minute (cpm) and vergence facilities by 3.72 cpm.

The experimental group demonstrated a statistically significant improvement in both accommodative and vergence facilities compared to a control group watching a film, suggesting that VR gaming could be a viable method for treating visual function issues, although further research is needed due to the study's limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Study to Assess the Feasibility of Utilising Virtual Reality for the Treatment of Accommodative and Vergence Infacility. Munsamy, A., Paruk, H.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A Study to Assess the Feasibility of Utilising Virtual Reality for the Treatment of Accommodative and Vergence Infacility. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Convergence Insufficiency Symptom Survey Scores for Reading Versus Other Near Visual Activities in School-Age Children. [2015]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Comparison of Three Vision Therapy Approaches for Convergence Insufficiency. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Vergence/accommodative therapy for symptomatic convergence insufficiency in children: Time course of improvements in convergence function. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment and compliance with virtual reality and anaglyph-based training programs for convergence insufficiency. [2022]