Status:

ENROLLING_BY_INVITATION

AI-Powered Artificial Vision for Visual Prostheses

Lead Sponsor:

University of California, Santa Barbara

Collaborating Sponsors:

Universidad Miguel Hernandez de Elche

Conditions:

Blindness, Acquired

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Visual impairment is one of the ten most prevalent causes of disability and poses extraordinary challenges to individuals in our society that relies heavily on sight. Living with acquired blindness no...

Detailed Description

The investigators will perform basic experimental studies involving humans (BESH) designed to quantify the perceptual experiences of visual prosthesis patients. These experiments will follow standard ...

Eligibility Criteria

Inclusion

  • Criteria for inclusion of visual prosthesis users:
  • Subject must be at least 18 years of age;
  • Subject has been implanted with a visual prosthesis (e.g., Argus II, Orion, Cortivis)
  • Subject has healed from surgery and the surgeon has cleared the subject for programming;
  • Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback);
  • Subject is willing to conduct psychophysics testing up to 4-6 hours per day of testing on 3-5 consecutive days;
  • Subject is capable of understanding patient information materials and giving written informed consent;
  • Subject is able to walk unassisted.
  • Criteria for inclusion of sighted control subjects:
  • Subject speaks English;
  • Subject must be at least 18 years of age;
  • Subject has visual acuity of 20/40 or better (corrected);
  • Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback);
  • Subject is capable of understanding participant information materials and giving written informed consent.
  • Subject is able to walk unassisted
  • Exclusion criteria:
  • Visual prosthesis users: Subject is unwilling or unable to travel to testing facility for at least 3 days of testing within a one-week timeframe;
  • Sighted controls: Subject has a history of motion sickness or flicker vertigo
  • All: Subject has language or hearing impairment

Exclusion

    Key Trial Info

    Start Date :

    October 2 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 31 2027

    Estimated Enrollment :

    7 Patients enrolled

    Trial Details

    Trial ID

    NCT06117332

    Start Date

    October 2 2023

    End Date

    August 31 2027

    Last Update

    July 31 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of California, Santa Barbara

    Santa Barbara, California, United States, 93106

    2

    University Miguel Hernandez

    Elche, Alicante, Spain, 03202