Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT06117332
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06117332
Study Brief:
Protocol Section:
NCT06117332