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Argus II/ORCAM Device Study

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ClinicalTrials.gov Identifier: NCT03248388
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : November 12, 2018
Sponsor:
Collaborators:
Second Sight Medical Products
Orcam Technologies Ltd.
Information provided by (Responsible Party):
Raymond Iezzi, 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.


Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Device: Argus II Eyeglasses Device: ORCAM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Utility of Visual Pattern Recognition Technology in Retinal Prosthesis Patients: the ARGUSII/ORCAM Device Study
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adults with Retinitis Pigmentosa using ARGUS II
Subjects will use the ORCAM system mounted onto the Argus II eyeglasses.
Device: Argus II Eyeglasses
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.

Device: ORCAM
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.




Primary Outcome Measures :
  1. Number of Subjects Who Are Able to Use the ORCAM device With the Argus II Device at the End of the Study [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248388


Contacts
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Contact: Heidi S Rubin, CCRP 507-538-8119 rubin.heidi@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Heidi S Rubin, CCRP    507-538-8119    rubin.heidi@mayo.edu   
Contact: Dan Hamiel    507-538-4122      
Sponsors and Collaborators
Mayo Clinic
Second Sight Medical Products
Orcam Technologies Ltd.
Investigators
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Principal Investigator: Raymond Iezzi Mayo Clinic

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Responsible Party: Raymond Iezzi, Associate Professor of Ophthalmology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03248388     History of Changes
Other Study ID Numbers: 17-003289
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn