Virtual Reality for Eye Movement Disorders

(OCNP Trial)

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is investigating whether eye exercises for abducens palsy and internuclear ophthalmoplegia increase ocular range of motion in the paretic direction when performed in virtual reality under head-cancelled compared to head-active conditions.

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 data supports the effectiveness of the treatment Head-Cancelled Virtual Reality Therapy for eye movement disorders?

Research shows that virtual reality can be effectively used to assess and treat eye conditions like strabismus (misalignment of the eyes) and amblyopia (lazy eye), suggesting potential benefits for eye movement disorders. Virtual reality therapy has also been beneficial in managing other conditions, such as phantom limb pain and vestibular disorders, indicating its versatility and potential effectiveness in various therapeutic settings. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating eye movement disorders?

Research on virtual reality therapy for various conditions, including brain rehabilitation and anxiety disorders, suggests it is generally safe, with some users experiencing mild side effects like dizziness. Newer virtual reality systems have improved safety features, reducing adverse effects. ^{2 6 7 8 9}

How is Head-Cancelled Virtual Reality Therapy different from other treatments for eye movement disorders?

Head-Cancelled Virtual Reality Therapy is unique because it uses virtual reality technology to treat eye movement disorders, allowing for individualized eye training without the need for head fixation. This approach offers a safe and controlled environment to improve visual functions, which is different from traditional methods that may require physical restraints or less interactive techniques. ^{1 2 10 11 12}

Research Team

Kevin E Houston, OD

Principal Investigator

University of Massachusetts, Worcester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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-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 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]

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]

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]

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]

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 (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]

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]

References

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

Stepping into the virtual unknown: feasibility study of a virtual reality-based test of ocular misalignment. [2018]

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

Design and assessment of amblyopia, strabismus, and myopia treatment and vision training using virtual reality. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Use of virtual reality for the management of phantom limb pain: a systematic review. [2023]

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

Virtual Reality Game Playing in Amblyopia Therapy: A Randomized Clinical Trial. [2021]

5. United States 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. [2023]

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

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. [2012]

7. Switzerland 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. [2020]

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

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Modified virtual reality technology for treatment of amblyopia. [2019]

10. China pubmed.ncbi.nlm.nih.gov

Virtual Reality and Augmented Reality in Ophthalmology: A Contemporary Prospective. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A systematic review: Virtual-reality-based techniques for human exercises and health improvement. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Virtual reality for rehabilitation in Parkinson's disease. [2022]