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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual-reality convergence training game to improve near vision problems in veterans with traumatic brain injury (TBI). Many veterans struggle to focus on nearby objects, making tasks like reading or using a smartphone difficult. The trial aims to determine if this game can enhance vision and simplify daily life. Veterans living near Cleveland, who have had a recent eye exam and experience near vision issues after a TBI, might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 prior data suggests that this virtual-reality convergence training game is safe for improving near vision in Veterans with TBI?

Research shows that virtual reality (VR) games, like the one used in this study, are generally easy for people to handle. One study found that playing a VR game for just 25 minutes improved eye coordination. Another study showed that a VR training program helped people with eye alignment issues.

Although no serious side effects have been reported, this is an early-phase trial, so safety remains under close observation. However, using VR in similar situations usually does not cause major problems. Participants might experience minor discomfort, such as eye strain, which is common with any screen-based activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for convergence insufficiency involve eye exercises like pencil push-ups or in-office vision therapy. However, this new virtual-reality convergence training game stands out by offering an immersive and engaging way to improve eye coordination and focus. Researchers are excited because virtual reality could make therapy more enjoyable and accessible, potentially increasing patient adherence and effectiveness. Additionally, this technology allows for personalized treatment experiences, adapting in real-time to the user’s progress, which is not possible with traditional methods.

What evidence suggests that this virtual-reality convergence training game is effective for improving near vision in Veterans with TBI?

Research has shown that virtual reality-based vision therapy can greatly improve symptoms of convergence insufficiency, a condition where the eyes struggle to work together when focusing on nearby objects. One study found that this therapy improved eye coordination and focus. Another study discovered that using a VR game for eye exercises enhanced the ability to use both eyes together in people with similar vision issues. Additionally, virtual reality gaming improved eye movement control in young adults. In this trial, participants will experience different sequences of intervention and non-intervention blocks using the VR convergence training game. These findings suggest that the VR convergence training game may effectively help veterans with vision problems after a concussion. ^{2 6 7 8 9}

Who Is on the Research Team?

Mark F. Walker, MD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11984992/

A virtual approach: Systematic review and meta-analysis of ...

Convergence insufficiency (CI) refers to the inability to accurately move eyes together and inward direction while focusing on a near object from a far object., ...

2.

nature.com

nature.com/articles/s41598-024-78088-w

Virtual reality head-mounted display game for intermittent ...

This study showed that gamification using our VR-based orthoptic training program for patients with intermittent exotropia resulted in ...

3.

bmcophthalmol.biomedcentral.com

bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-022-02393-z

Virtual reality-based vision therapy versus OBVAT in the ...

Virtual reality-based vision therapy significantly improved binocular vision functions and symptoms in patients with convergence insufficiency ...

4.

tandfonline.com

tandfonline.com/doi/abs/10.1111/cxo.13057

Treatment and compliance with virtual reality and anaglyph ...

Two interventions, anaglyphs and a virtual reality game of Snakes, were evaluated for their effectiveness in treating adults with convergence insufficiency.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1888429620300108

The effect of gaming on accommodative and vergence ...

The results showed that binocular accommodative facilities and vergence facilities increased after 25 min of VR gaming in emmetropic participants under 30 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7301196/

The effect of gaming on accommodative and vergence ...

The results showed that binocular accommodative facilities and vergence facilities increased after 25 min of VR gaming in emmetropic participants under 30 years ...

7.

library.imaging.org

library.imaging.org/admin/apis/public/api/ist/website/downloadArticle/ei/30/4/art00003

Use of virtual reality to assess and treat weakness in human ...

A notable recent success for vision therapy is in the treatment of convergence insufficiency (CI). In CI, the eyes don't turn inward sufficiently during near ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S216209892300097X

Virtual Reality and Augmented Reality in Ophthalmology

They demonstrated that VR performance scores in patients with peripheral field loss (56.65) and central field loss (63.25) were lower (P < 0.001) than normal ...

9.

researchgate.net

researchgate.net/publication/388733563_Virtual_reality_head-mounted_display_game_for_intermittent_exotropia_in_a_randomized_controlled_trial

(PDF) Virtual reality head-mounted display game for ...

After using the VR game for 4 weeks, the near angle of exodeviation significantly decreased from 29.6 ± 9.5∆ to 25.3 ± 9.0∆ in the exercise group (p < 0.001), ...