SuspendedNot Applicable

A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals

Stopped: Study was suspended 4/16/2020 due to global pandemic. Plans to restart or permanently end the study are still being evaluated.

United States3 participantsStarted 2020-03-06

Plain-language summary

This study aims to validate an observer-rated assessment titled "Functional Low-Vision Observer Rated Assessment (FLORA-20)", which comprises 20 functional vision tasks commonly performed in or around a blind individual's home environment. This study shall be carried out with individuals who have an implanted visual prosthesis device. There are no new implantations or changes to the original implant or external wearables being studied or tested. Additionally, data from the study shall not be used alter standard of care or the user's treatment options.

Who can participate

Age range

22 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects implanted with the Argus II or Orion device * Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent * Subject is able to follow instructions and comply with FLORA-20 scheduling and completion of tasks * Subject is willing to be filmed while performing the FLORA-20 tasks during the study Exclusion Criteria: * Subject is unsuitable for study participation as determined by Investigator's clinical judgment (with Sponsor's final input).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Inter-observer reliability

Timeframe: Single 1 day visit

Intra-observer reliability

Timeframe: Single 1 day visit

Trial details

NCT IDNCT04312763

SponsorSecond Sight Medical Products

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-08

View on ClinicalTrials.gov More Blindness, Acquired trials