Comparing performance of blind participants using the ARIA Device

A Controlled, Open Label Pilot Study to Assess the Safety, Efficacy, and Usability of the ARIA Device With Blind Individuals Who Have no Light Perception or Light Perception Only

This study tests how well the ARIA Device, which is a pair of augmented reality glasses, helps blind people navigate their surroundings by comparing their performance on everyday tasks with and without the device.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ARIA Research Pty Ltd (industry)
• Locations: 1 site (Sydney, New South Wales)
• Trial ID: NCT06477809 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the safety, efficacy, and usability of the ARIA Device, which consists of augmented reality glasses connected to a mobile app, designed to assist blind individuals in navigating their environment. Participants will perform 12 everyday tasks both with and without the device, allowing for a direct comparison of its impact on their performance. The study emphasizes co-design with blind individuals to ensure the technology meets their needs effectively. Data will be collected through a mixed methods approach, prioritizing qualitative feedback to validate the findings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 with no light perception or only light perception, who are independent cane travelers and can participate in multiple research sessions.

Not a fit: Patients with vision better than light perception or those with severe hearing loss requiring aids may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance the independence and quality of life for individuals with blindness by providing timely and accurate environmental information.

How similar studies have performed: While assistive technologies for the blind have been explored, the specific approach of using augmented reality in audio is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

* Individuals over the age of 18
* Working English proficiency
* No light perception, or light perception only (VROOM score \<10/50).
* Ambulant, with sufficient stamina to stand/walk for at least 30 minutes between breaks during a 3-4 hour research session.
* Independent long cane traveller.
* Sufficient hearing for conversation, with no hearing aids and no worse than mild to moderate hearing loss.
* Smartphone skills and familiarity with at least one app/device useful for wayfinding.
* Able to attend 4 research sessions in person at the investigation site in Haymarket, Sydney.
* Able to comply with all investigational requirements.

Exclusion Criteria:

* Under 18 years, or adults unable to give informed consent (e.g., under guardianship).
* Vision greater than light perception only (VROOM \>10/50).
* Physical limitations that compromise stamina needed to complete a four-hour research session.
* Hearing aids; severe-profound hearing loss determined as insufficient hearing for unaided conversation
* No smartphone skills or prior use of assistive technology.
* Unwilling to be videoed during research tasks.
* Unlikely to attend all follow-up study visits.

Where this trial is running

Sydney, New South Wales

• ARIA Research — Sydney, New South Wales, Australia (RECRUITING)

Study contacts

• Principal investigator: Lil Deverill, PhD — Director of Clinical Trials
• Study coordinator: Warren R Bingham

Conditions: Blindness and Low Vision