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
Trial ID: NCT06477809
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-07-29
Completion date: 2024-12-21
Sponsor: ARIA Research Pty Ltd
Collaborators: University of Sydney
Conditions: Blindness and Low Vision
Interventions: ARIA Glasses ( Augmented Reality in Audio )
Locations: ARIA Research
Countries: Australia
Enrollment: 20
Age range: 18 Years - None
Sex: ALL

Summary:
Summary The environment in which we live, play and travel is primarily built by and for people with sight. Navigating the sighted world with blindness can be exhausting, as it involves disorientation, social isolation, increased risk, frustration and inefficiency. Accessing timely information about the environment is necessary to navigate an efficient path of travel and reduce the effort involved in living with blindness.

Numerous assistive technologies have been developed to improve access to information, and quality of life for people with blindness, however persistent technology limitations include affordability, unreliable internet connection, lag and limited battery life. Existing technologies can offer scene description or text-to-voice quite effectively when the user is standing still, but not quickly enough to gain benefit when on the move. Timely information is crucial at road crossings, where poor decisions can result in injury. Information lag or deficit also compounds travel fatigue due to time and energy wasted in searching, uncertainty and frustration.

Blind users are often brought in to test new technologies or devices in controlled, clinical conditions, when it is too late to influence design. There is little evidence of testing these technologies in lived environments to understand the functional benefits for the blind population, partly because there is a dearth of available methods and measures to embrace the complexity of functional research.

This study will test the safety, efficacy and usability of the ARIA Device in 12 varied research tasks undertaken by blind participants in clinical, social and outdoor lived environments, comparing ARIA performance with each participant's ordinary (non-ARIA) methods of undertaking the same tasks. The study uses an embedded mixed methods design with a qualitative priority, generating rich, precise data about what matters to participants and what they can do in diverse situations.

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.

Outcomes:
ARIA Device Safety