Blindness, AcquiredFLORA-20NCT04312763
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals
An observational study of Blindness, Acquired, run by Second Sight Medical Products at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 74 years
- Conditions the study is for
- Blindness, Acquired
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to 20 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 30 users with the Argus II or Orion system from the US will be enrolled.
Who may be able to join
- 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
Who cannot join
- Subject is unsuitable for study participation as determined by Investigator's clinical judgment (with Sponsor's final input).
Trial locations and contacts
1 site in 1 country.
United States1 site
Second Sight Medical Products, Inc.
Sylmar, California, 91342
About this study
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.
- Conditions
- Blindness, Acquired
- Keywords
- Observer-rated instrument
- Medical subject headings
- Blindness
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-observer reliability
Intraclass correlation coefficient (ICC) of the overall FLORA-20 scores provided by each of the assessors (in-person and remote)
Measured: Single 1 day visit
Intra-observer reliability
ICC of the overall FLORA-20 scores provided by the same assessor, assessed and re-assessed at two different time points
Measured: Single 1 day visit
Secondary outcomes (4)
Improvement in Average Performance, ON vs. OFF
Paired t-test to determine if there is a statistically significant improvement in average performance from ON vs. OFF
Measured: Single 1 day visit
Clinical Meaningfulness (Effect Size)
Cohen's d calculation of overall FLORA-20 scores between device ON vs. OFF
Measured: Single 1 day visit
Internal consistency - Cronbach's alpha
Cronbach's alpha of the individual FLORA-20 task scores
Measured: Single 1 day visit
Internal consistency - item-total correlations
Item-total correlations for each FLORA-20 task
Measured: Single 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start6 Mar 2020
- Primary completion8 Dec 2024 (estimated)
- Study completion20 Feb 2025 (estimated)
Why it stopped: Study was suspended 4/16/2020 due to global pandemic. Plans to restart or permanently end the study are still being evaluated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blindness, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Sight Medical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Biomedical Associates
- Responsible party
- Sponsor
- Investigators
- Uday Patel, PhD, Principal investigator, Second Sight Medical Products, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312763
- Sponsor's protocol ID
- CP-11
- Acronym
- FLORA-20
- Status last verified
- Nov 2023
- First submitted
- 16 Mar 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals
- ClinicalTrials.gov ID
- NCT04312763
- Acronym / sponsor ID
- FLORA-20 / CP-11
- Conditions
- Blindness, Acquired
- Keywords
- Observer-rated instrument
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study was suspended 4/16/2020 due to global pandemic. Plans to restart or permanently end the study are still being evaluated.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Second Sight Medical ProductsIndustry (pharma, biotech, devices)
- Collaborators
- Boston Biomedical Associates
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 8 Dec 2024 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 30 users with the Argus II or Orion system from the US will be enrolled.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Subject is unsuitable for study participation as determined by Investigator's clinical judgment (with Sponsor's final input).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-observer reliability
Time frame: Single 1 day visit
Intraclass correlation coefficient (ICC) of the overall FLORA-20 scores provided by each of the assessors (in-person and remote)
Intra-observer reliability
Time frame: Single 1 day visit
ICC of the overall FLORA-20 scores provided by the same assessor, assessed and re-assessed at two different time points
4 secondary outcomes
Improvement in Average Performance, ON vs. OFF
Time frame: Single 1 day visit
Clinical Meaningfulness (Effect Size)
Time frame: Single 1 day visit
Internal consistency - Cronbach's alpha
Time frame: Single 1 day visit
Internal consistency - item-total correlations
Time frame: Single 1 day visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uday Patel, PhD principal investigator
Second Sight Medical Products, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blindness, Acquired, run by Second Sight Medical Products at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-observer reliability (time frame: Single 1 day visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.