Argus II/ORCAM Device Study
Utility of Visual Pattern Recognition Technology in Retinal Prosthesis Patients: the ARGUSII/ORCAM Device Study
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedStudy Start
First participant enrolled
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedJanuary 13, 2022
January 1, 2022
3.1 years
August 8, 2017
January 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects Who Are Able to Use the ORCAM device With the Argus II Device at the End of the Study
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.
End of study, approximately 4 months
Study Arms (1)
Adults with Retinitis Pigmentosa using ARGUS II
EXPERIMENTALSubjects will use the ORCAM system mounted onto the Argus II eyeglasses.
Interventions
The Argus II Eyeglasses (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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- No Argus II implant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Second Sight Medical Productscollaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Iezzi
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Ophthalmology
Study Record Dates
First Submitted
August 8, 2017
First Posted
August 14, 2017
Study Start
August 31, 2017
Primary Completion
October 15, 2020
Study Completion
October 15, 2020
Last Updated
January 13, 2022
Record last verified: 2022-01