Streetlab VR for AMD

Overseen By Eleonora Lad, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Dense cataracts, Glaucoma, High myopia, others

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

Compensation: Varies

Number of Visits: 1

100 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. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Streetlab VR for AMD?

Research shows that virtual reality (VR) technology, like Streetlab VR, can help people with low vision, including those with age-related macular degeneration (AMD), by improving their ability to recognize objects, faces, and colors. This is partly due to the high brightness of VR displays, which can enhance visual clarity and color perception. ^{1 2 3 4 5}

What safety data exists for Streetlab VR or similar treatments?

The research articles provided do not contain specific safety data for Streetlab VR or similar treatments. They discuss general safety evaluation methods and adverse drug reactions but do not mention Streetlab VR or related technologies. ^{6 7 8 9 10}

How does the Streetlab VR treatment for AMD differ from other treatments?

Streetlab VR for AMD is unique because it uses virtual reality technology to potentially enhance visual perception and navigation for patients with age-related macular degeneration (AMD). Unlike traditional treatments that focus on slowing disease progression or improving vision through medication or surgery, this approach aims to improve quality of life by leveraging immersive technology to compensate for vision loss. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.

Research Team

Eleonora Lad, MD, PhD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults over 50 with early to intermediate dry age-related macular degeneration or geographic atrophy, and healthy individuals as controls. Participants must be able to consent and have no conditions like dense cataracts, severe myopia, nystagmus, glaucoma requiring treatment, or any condition that could affect the study's procedures.

Inclusion Criteria

I am able and willing to give my consent.

I am 50 years old or older.

I have early or intermediate dry age-related macular degeneration or geographic atrophy, or my macula is healthy.

Exclusion Criteria

I am under 50 years old.

I have dense cataracts in my eye(s) affecting my vision tests.

High myopia -8 Diopters or more severe

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Visit Assessment

Participants undergo a comprehensive eye exam, rod-mediated dark adaptation measurement, reading performance assessment, and mobility test

1 day

1 visit (in-person, approximately 5-6 hours)

Follow-up

Participants are monitored for changes in ellipsoid zone attenuation over time

Approximately 2 years

Treatment Details

Interventions

• Streetlab VR

Trial Overview The study examines how well older adults with different stages of AMD can adapt to darkness and read in dim light using a virtual reality system called Streetlab VR. It aims to link dark adaptation (which relies on rod photoreceptors) with reading performance under low illumination.

Participant Groups

Group I: Intermediate AMD Experimental Treatment 1 Intervention

Study patients who have a diagnosis of Intermediate AMD

Group II: Geographic Atrophy Experimental Treatment 1 Intervention

Study patients who have a diagnosis of Geographic Atrophy

Group III: Early AMD Experimental Treatment 1 Intervention

Study patients who have a diagnosis of early AMD

Group IV: AMD Controls Experimental Treatment 1 Intervention

Study patients who have healthy eyes

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

StreetLab Vision

Industry Sponsor

Trials

2

Recruited

180+

Findings from Research

Current VR headsets have a minimum angular resolution of 0.41 logMAR on average, which is inadequate for reliable visual acuity testing and may not be suitable for treating conditions like amblyopia.

The average field of view for VR headsets is about 50.2°, which is significantly lower than manufacturer claims, but it may still be sufficient for certain visual field tests, although concerns exist for vergence testing due to varying eye-to-screen distances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Virtual Reality Headset Resolution and Field of View: Implications for Vision Care Applications. Lynn, MH., Luo, G., Tomasi, M., et al.[2021]

In a survey of 459 members of the British Pharmacological Society, it was found that drugs were administered to 8163 healthy volunteers, with only 6.9% experiencing minor adverse effects and 0.04% facing potentially life-threatening effects, indicating a very low risk associated with these studies.

Among 7607 healthy student volunteers, only 6.0% reported minor adverse effects during drug administration for educational purposes, with no severe adverse effects noted, reinforcing the overall safety of drug administration in healthy volunteer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. Orme, M., Harry, J., Routledge, P., et al.[2019]

The American Statistical Association's Interactive Safety Graphics Task Force has created a new interactive tool for analyzing drug safety data, specifically focusing on drug-induced liver damage, which enhances the review process.

This innovative tool, based on advancements in visual data processing and programming, serves as a prototype for developing additional interactive safety analysis tools, aiming to improve the evaluation of large safety datasets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group. Buchanan, J., Li, M., Ni, X., et al.[2021]

Only 2 out of 15 participants reported adverse drug reactions (ADRs) directly to the MedEffect system, with most opting to inform their physicians or pharmacists instead, highlighting a lack of awareness about the reporting system.

Barriers to reporting included physicians downplaying side effects, confusion about what to report, and a lack of feedback after submission, suggesting that simplifying the MedEffect reporting forms could improve patient engagement in ADR reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experiences on adverse drug reactions reporting: a qualitative study. Al Dweik, R., Yaya, S., Stacey, D., et al.[2021]

The base-in multiplexing prism (MxP) glasses significantly improved the ability of patients with acquired monocular vision (AMV) to detect pedestrians approaching from their blind side, providing a true field expansion of about 25°.

In a virtual reality walking environment, participants with simulated AMV showed better pedestrian detection rates when using the MxP, indicating that these glasses could help reduce collision risks for individuals with AMV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Field Expansion with Multiplexing Prism Glasses Improves Pedestrian Detection for Acquired Monocular Vision. Jung, JH., Castle, R., Kurukuti, NM., et al.[2023]

References

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

Advanced Visualization Engineering for Vision Disorders: A Clinically Focused Guide to Current Technology and Future Applications. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Users' subjective evaluation of electronic vision enhancement systems. [2019]

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

The Accessibility of Commercial Off-The-Shelf Virtual Reality for Low Vision Users: A Macular Degeneration Case Study. [2020]

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

Measuring Virtual Reality Headset Resolution and Field of View: Implications for Vision Care Applications. [2021]

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

Comparison of functional mobility performance with clinical vision measures in simulated retinitis pigmentosa. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Differences between self-reported and verified adverse cardiovascular events in a randomised clinical trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group. [2021]

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

Safety Pharmacology Society: 9th Annual Meeting. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Patients' experiences on adverse drug reactions reporting: a qualitative study. [2021]

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

Gaussian Light Field: Estimation of Viewpoint-Dependent Blur for Optical See-Through Head-Mounted Displays. [2017]

12. China pubmed.ncbi.nlm.nih.gov

[Virtual colonoscopy navigation based on colon division]. [2016]

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

Field Expansion with Multiplexing Prism Glasses Improves Pedestrian Detection for Acquired Monocular Vision. [2023]

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

High-fidelity eye, head, body, and world tracking with a wearable device. [2022]

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

Collision judgment when using an augmented-vision head-mounted display device. [2021]