A Study to Evaluate the Argus II/ORCAM Device
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-003289
NCT ID: NCT03248388
Sponsor Protocol Number: 17-003289
About this study
The purpose of this study is to determine if wearable, text-to-speech (TTS) and visual pattern recognition (VPR) technology can be used to extend the capabilities of the Argus II to allow patients to read and recognize faces and objects. Using the prosthesis, patients can identify obstacles, handles, switches, eating utensils and demonstrate improved navigation when used in conjunction with other ambulation-assist tools. The FDA has approved the Argus II as a humanitarian device. Present-day wearable text-to-speech converters are also capable of object and face recognition. Such systems have been developed to assist with these tasks in patients with severe low-vision.
ORCAM is a commercially-available eyeglass-mounted visual pattern recognition system capable of converting photographs of text to speech. It is comprised of a camera, a small belt-worn computer, pattern recognition software and a small audio transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize faces and speak the name of the individual to the user. ORCAM can also be used to recognize everyday products after being programmed.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Diagnosis of advanced retinitis pigmentosa.
- Subjects must have an Argus II device implanted to be eligible for this study.
- Subjects must be familiar with using their Argus II device.
Exclusion Criteria:
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Raymond Iezzi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available