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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 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.

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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.

Conditions Studied

Interventions

  • DEVICE Argus II Eyeglasses
  • DEVICE ORCAM

Study Locations (1)

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2017-08-31
Est. Completion 2020-10-15
Phase NA

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT03248388

The ClinicalTrials.gov registry entry for NCT03248388 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (98% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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