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

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and usability of the ARIA Device, an assistive technology designed for adults who are blind or have very limited vision. The study focuses on how the ARIA Device helps with everyday tasks in various environments, including clinical, social, and outdoor settings. This pilot study uses a mixed methods approach prioritizing qualitative data to understand what matters to blind participants and how they perform with and without the device. Participants will use the ARIA Device, which consists of augmented reality glasses connected to a mobile phone app that creates a soundscape from camera vision. This soundscape helps users identify objects and estimate distances by audio cues. The device is worn with a lanyard and backpack to keep hands free for other aids like a cane or guide dog. Each participant completes 12 tasks reflecting real-life activities both with and without the ARIA Device over four sessions at a research center and nearby outdoor locations. Participants take part in interviews, baseline assessments, training with the ARIA Device, and then perform the 12 specially designed tasks in different settings. Researchers observe, record, and rate performance and usability, also collecting data on safety and participant wellbeing. The study includes hearing and spatial cognition tests, quality of life questionnaires, and continuous safety monitoring during the sessions. The entire study lasts about a month with four on-site sessions for each participant.

A Pilot Study Comparing Performance of Blind Participants on 12 Tasks, With and Without the ARIA Device