Clinical trial NCT03248388: Argus II/ORCAM Device Study
Official title: Utility of Visual Pattern Recognition Technology in Retinal Prosthesis Patients: the ARGUSII/ORCAM Device Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Second Sight Medical Products
First posted: 2017-08-14
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is being done 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.

The Argus II retinal prosthesis can restore rudimentary forms of vision to patients with bare light-perception vision. Using the prosthesis, patients can identify obstacles, handles, switches, eating utensils and demonstrate improved navigation when used in conjunction with other ambulation-assist tools. Current limits in the resolution of the device prevent useful reading or face recognition. 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.

Detailed description: The Orcam device will be mounted onto the Argus II eyeglasses. The subject will be asked to use the Orcam device with and without the Argus II. After a half-day interactive training session with the Orcam device, the investigators will interview the subject with a questionnaire. The investigators will then contact the subject every two weeks via a telephone call for two months (4 phone interviews). The investigators will then ask the subject to return to Mayo Clinic to demonstrate their ability to use the Argus II and Orcam together and separately. These sessions will be videotaped.

Eligibility criteria: 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:

- No Argus II implant

Primary outcomes:
measure: Number of Subjects Who Are Able to Use the ORCAM device With the Argus II Device at the End of the Study
timeFrame: End of study, approximately 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Raymond Iezzi
role: PRINCIPAL_INVESTIGATOR
References: