Argus II/ORCAM Device Study

Not Applicable

Completed

• Conditions: Retinitis Pigmentosa
• Interventions: Device: Argus II Eyeglasses; Device: ORCAM

• Registration Number: NCT03248388
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Study Start: 2017-08-31
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adults with Retinitis Pigmentosa using ARGUS II	ORCAM	Subjects will use the ORCAM system mounted onto the Argus II eyeglasses.
Adults with Retinitis Pigmentosa using ARGUS II	Argus II Eyeglasses	Subjects will use the ORCAM system mounted onto the Argus II eyeglasses.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Are Able to Use the ORCAM device With the Argus II Device at the End of the Study	End of study, approximately 4 months	Subjects will be familiar with using their retinal prosthesis, the Argus II Device. At baseline, the ORCAM device will be mounted on the Argus II eyeglasses.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States