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Argus II/ORCAM Device Study
NCT03248388 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03248388
The ClinicalTrials.gov registry entry for NCT03248388 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03248388 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03248388?
The interventions under investigation include: Argus II Eyeglasses (DEVICE), ORCAM (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03248388?
This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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