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NCT03248388 · ClinicalTrials.gov registry record · NA
Argus II/ORCAM Device Study
A NA study of Retinitis Pigmentosa, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT03248388: Completed NA study of Retinitis Pigmentosa, sponsored by Mayo Clinic.
NCT03248388 is a NA study of Retinitis Pigmentosa that has completed, run by Mayo Clinic. The registered enrollment target is 4 participants, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03248388, a NA study of Retinitis Pigmentosa, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Argus II Eyeglasses
- DEVICE ORCAM
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2017-08-31 |
| Est. Completion | 2020-10-15 |
| Phase | NA |
What the finished NCT03248388 record still lists
NCT03248388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Retinitis Pigmentosa appearing as the primary indexed condition, and to 2 interventions - of which Argus II Eyeglasses is the first listed.
NCT03248388 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03248388 about?
NCT03248388 is a clinical study titled "Argus II/ORCAM Device Study". 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 v...
What is the current status of trial NCT03248388?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2017-08-31. Estimated completion is 2020-10-15.
What conditions does trial NCT03248388 study?
This clinical trial studies the following conditions: Retinitis Pigmentosa.
What interventions are being tested in trial NCT03248388?
The interventions under investigation include: Argus II Eyeglasses (DEVICE), ORCAM (DEVICE).
Who is sponsoring clinical trial NCT03248388?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03248388 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Retinitis Pigmentosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03248388's enrollment target sits among peer trials
4 37th of 37 the lowest of 37 other Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinitis Pigmentosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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