Virtual Reality for Eye Movement Disorders

(OCNP Trial)

Not currently recruiting at 1 trial location

Overseen By Michelle Manxhari, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kevin Houston

Disqualifiers: Bilateral OCNP, Visual acuity, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality eye exercises can improve eye movement in individuals with certain eye movement disorders. It specifically examines abducens palsy and internuclear ophthalmoplegia, comparing exercises performed with a stable head to those with a moving head. Participants with one affected eye, significant movement limitation, and sufficient eyesight to use a VR headset may be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for eye movement disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators.

What prior data suggests that this virtual reality therapy is safe for eye movement disorders?

Research has shown that Head-Cancelled Virtual Reality is under study for eye movement disorders. While detailed information on side effects remains limited, virtual reality in medical settings is generally considered safe. This technology is already used in some rehabilitation treatments, suggesting it is well-tolerated.

In other studies on similar conditions, researchers have closely monitored virtual reality for safety. Reports of serious side effects are rare. Most individuals experience only minor issues, such as dizziness or eye strain, which typically resolve quickly.

As this trial is in an early stage, the treatment's safety is still under evaluation. However, the current use of virtual reality in medical treatments for eye conditions provides some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality for Eye Movement Disorders trial because it explores a novel way to address eye movement issues using head-cancelled virtual reality. Unlike traditional treatments that might involve medications or physical therapy, this approach leverages immersive technology to create a unique therapeutic experience. The head-cancelled virtual reality method aims to stabilize the visual environment, potentially offering a more engaging and effective way to retrain the eyes and brain in managing these disorders. This innovative use of technology could provide new insights into non-invasive treatment options, making it a promising area of exploration.

What evidence suggests that Head-Cancelled Virtual Reality is effective for eye movement disorders?

Research has shown that virtual reality can help improve eye movement problems. In this trial, participants will join different study arms to evaluate the effectiveness of Head-Cancelled Virtual Reality Therapy. This therapy has shown promise in increasing the range of motion for people with certain eye conditions. Virtual reality offers controlled and engaging exercises that might outperform traditional methods. Previous studies have demonstrated that these exercises can enhance eye coordination and control. Early findings suggest that using virtual reality for eye exercises can lead to better outcomes for people with eye movement issues. ^{1 3 4 5 6}

Who Is on the Research Team?

Kevin E Houston, OD

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for individuals with ocular cranial nerve palsies (OCNP) affecting one eye and significantly limiting its movement, or healthy volunteers without OCNP or related conditions. Participants must have decent vision with correction, speak English fluently, and be able to give informed consent. Those with bilateral OCNP, poor visual acuity, significant vision differences between eyes, less affected range of motion, or issues that prevent VR headset use are excluded.

Inclusion Criteria

OCNP Group: Able to provide informed consent and will be able to fluently read and understand spoken English

I do not have any brain or eye nerve diseases.

Normal Group: No strabismus

Exclusion Criteria

OCNP Group: Presence of bilateral OCNP

OCNP Group: Visual acuity worse than 20/100 in either eye

OCNP Group: Greater than 4-line difference in visual acuity between the eyes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform eye exercises in virtual reality under head-cancelled and head-active conditions

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Head-Cancelled Virtual Reality

Trial Overview The study tests if virtual reality eye exercises can improve the range of motion in patients with abducens palsy and internuclear ophthalmoplegia. It compares exercises done under 'head-cancelled' conditions (where head movements don't affect the VR environment) versus 'head-active' conditions.

How Is the Trial Designed?

Group I: Head Cancelled Experimental Treatment 1 Intervention

Study tasks performed in head-cancelled conditions

Group II: Normal Active Control 1 Intervention

Study tasks performed in normal conditions.

Head-Cancelled Virtual Reality is already approved in United States, European Union for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Rehabilitation of ocular cranial nerve palsies
• Pain management
• Anxiety disorders
• Phobias
• Schizophrenia
• Eating disorders

Approved in European Union as Virtual Reality Therapy for:

• Rehabilitation of ocular cranial nerve palsies
• Pain management
• Anxiety disorders
• Phobias
• Schizophrenia
• Eating disorders

Who Is Running the Clinical Trial?

Kevin Houston

Lead Sponsor

Trials

2

Recruited

50+

American Academy of Optometry

Collaborator

Trials

6

Recruited

290+

Published Research Related to This Trial

Virtual reality (VR) shows promise as an effective intervention for treating eye conditions like amblyopia, strabismus, and myopia, based on a review of 48 studies published from 2000 to 2023.

The research indicates that different VR technologies, such as smartphone-based headsets for amblyopia and standalone headsets for myopia and strabismus, are being utilized, but further exploration of the virtual environments and systems is needed to confirm their clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and assessment of amblyopia, strabismus, and myopia treatment and vision training using virtual reality. Chan, HS., Tang, YM., Do, CW., et al.[2023]

Virtual reality (VR) interventions may lead to moderate improvements in step and stride length in people with Parkinson's disease compared to traditional physiotherapy, although the evidence is of low quality based on 8 trials with 263 participants.

VR and physiotherapy appear to have similar effects on gait, balance, and quality of life, with no reported adverse events from VR interventions, suggesting it is a safe option for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for rehabilitation in Parkinson's disease. Dockx, K., Bekkers, EM., Van den Bergh, V., et al.[2022]

A systematic review of 77 studies found that virtual reality (VR) and augmented reality (AR) technologies are being increasingly applied in ophthalmology, particularly in surgical training, diagnosis, and treatment.

While the current studies highlight the validity and usability of VR/AR technologies in ophthalmology, more long-term research is needed to assess their practical feasibility, efficacy, safety, and cost-effectiveness in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality and Augmented Reality in Ophthalmology: A Contemporary Prospective. Iskander, M., Ogunsola, T., Ramachandran, R., et al.[2022]

Virtual reality exposure therapy (VRET) significantly outperforms waitlist controls in treating anxiety disorders, indicating its effectiveness as an intervention.

When compared to traditional evidence-based treatments, VRET shows similar efficacy and stability of results over time, suggesting it can be a viable alternative or complement to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. Opriş, D., Pintea, S., García-Palacios, A., et al.[2012]

The Interactive Binocular Treatment (I-BiT) system is a novel virtual-reality approach designed to treat amblyopia by stimulating both eyes simultaneously, addressing issues of compliance and effectiveness seen with traditional patching methods.

This interactive VR system is adaptable to the patient's age and abilities, making the treatment more engaging and enjoyable, with ongoing research to evaluate its efficacy in improving amblyopia outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified virtual reality technology for treatment of amblyopia. Eastgate, RM., Griffiths, GD., Waddingham, PE., et al.[2019]

The study successfully tested a virtual reality headset for assessing ocular misalignment, showing that it can provide results consistent with traditional methods like the Lees screen.

This innovative approach eliminates the need for fixed head positions and allows for better control over testing conditions, suggesting it could enhance the diagnosis and monitoring of strabismus in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepping into the virtual unknown: feasibility study of a virtual reality-based test of ocular misalignment. Nesaratnam, N., Thomas, P., Vivian, A.[2018]

A meta-analysis of 44 studies showed that newer generation virtual reality head-mounted displays (HMDs) significantly reduce adverse symptoms and dropouts compared to older models, indicating improved safety and user experience.

Commercial versions of new generation HMDs, especially those with ergonomic features, reported zero incidents of adverse effects, making them suitable for use in cognitive neuroscience research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological Competence Is a Pre-condition for Effective Implementation of Virtual Reality Head Mounted Displays in Human Neuroscience: A Technological Review and Meta-Analysis. Kourtesis, P., Collina, S., Doumas, LAA., et al.[2020]

In a study involving 50 children aged 4 to 10 with unilateral amblyopia, both occlusion therapy (patching) and virtual reality game playing significantly improved visual acuity, but the virtual reality group showed a greater improvement in letter recognition.

The results suggest that virtual reality therapy is at least as effective as traditional patching for treating amblyopia, making it a promising new option for therapy in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Game Playing in Amblyopia Therapy: A Randomized Clinical Trial. Rajavi, Z., Soltani, A., Vakili, A., et al.[2021]

Virtual Reality (VR) has been shown to effectively enhance motor and functional skills in both children and adults, leveraging brain plasticity to improve cognitive function and motor disabilities in various neurological disorders.

Clinical studies indicate that VR training can significantly improve visual functions such as stereopsis and visual acuity in ophthalmological conditions, offering a non-invasive alternative to traditional methods that require eye occlusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review: Virtual-reality-based techniques for human exercises and health improvement. Ali, SG., Wang, X., Li, P., et al.[2023]

The study involving 78 patients with brain injury found that immersive virtual reality (VR) training is safe, with no serious adverse events reported, although some patients experienced minor issues like dizziness.

Patients who adhered to the VR training (participating 3 or more times) reported higher satisfaction and perceived effectiveness in their recovery from upper limb paralysis compared to those who participated less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. Lim, I., Cha, B., Cho, DR., et al.[2023]

Virtual reality-assisted therapy (VRAT) significantly improves vestibular symptoms in patients with peripheral vestibular disorders compared to conventional vestibular physical therapy (CVPT), as shown by various measures including the Dizziness Handicap Inventory (DHI).

While VRAT shows promise for enhancing rehabilitation outcomes, particularly for peripheral disorders, the high variability in study results indicates a need for further research with larger sample sizes to better understand its effectiveness across different vestibular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Virtual Reality-Assisted Therapy Offer Additional Benefits to Patients With Vestibular Disorders Compared With Conventional Vestibular Physical Therapy? A Meta-analysis. Chu, HY., Song, N., Zhou, ZR., et al.[2023]

Virtual reality (VR) therapy shows promise as an effective treatment for phantom limb pain (PLP), with 14 out of 15 studies reporting reductions in pain scores after VR sessions.

Combining VR therapy with tactile stimulation enhances its effectiveness, leading to greater reductions in PLP compared to VR therapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of virtual reality for the management of phantom limb pain: a systematic review. Hali, K., Manzo, MA., Koucheki, R., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-cranial-nerve-diseases-5-2024-33cd5

Virtual Reality for Eye Movement Disorders (OCNP Trial) What data supports the effectiveness of the treatment Head-Cancelled Virtual Reality Therapy for eye movement disorders? Research shows that virtual reality ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10036222/

Development and 5-year Evaluation of Diagnosis-Specific ... The most common diagnoses were hemispatial neglect (19.2%), homonymous field defects (18.5%), and oculomotor cranial nerve palsies (16.7%) (N=2083).

3. app.dimensions.ai app.dimensions.ai/details/grant/grant.2545626

Neurological Exams Teaching & Evaluation Using Virtual ... This proposal will develop, evaluate, and distribute a cranial nerve palsies VP module.

4. bop.unibe.ch bop.unibe.ch/JEMR/citationstylelanguage/get/apa?submissionId=8955&publicationId=9243&issueId=1158

APA The pupil near response is short lasting and intact in virtual reality head mounted displays. (2023). Journal of Eye Movement Research, ...

5. nanosweb.org nanosweb.org/files/Annual%20Meeting'/2025/2025_Analytical_Posters_Listing.pdf

51st Annual Meeting Disorders of. Neurologic and. Systemic Diseases. 274. Differentiating Myasthenia. Gravis and Cranial Nerve Palsies through Saccadic Eye. Movement Analysis: A.

6. umassmed.edu umassmed.edu/globalassets/ccts/ccts-media/2024-umccts-research-internship-placement-opportunities-final.pdf

2024-umccts-research-internship-placement-opportunities- ... Project 1: Head-cancelled virtual reality for rehabilitation of ocular cranial nerve palsies. Ocular cranial nerve palsies affect 15% of stroke patients ...