- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04312763
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals (FLORA-20)
November 20, 2023 updated by: Second Sight Medical Products
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 Overview
Status
Suspended
Conditions
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Sylmar, California, United States, 91342
- Second Sight Medical Products, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Up to 30 users with the Argus II or Orion system from the US will be enrolled.
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Single 1 day visit
|
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
|
Single 1 day visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Average Performance, ON vs. OFF
Time Frame: Single 1 day visit
|
Paired t-test to determine if there is a statistically significant improvement in average performance from ON vs. OFF
|
Single 1 day visit
|
Clinical Meaningfulness (Effect Size)
Time Frame: Single 1 day visit
|
Cohen's d calculation of overall FLORA-20 scores between device ON vs. OFF
|
Single 1 day visit
|
Internal consistency - Cronbach's alpha
Time Frame: Single 1 day visit
|
Cronbach's alpha of the individual FLORA-20 task scores
|
Single 1 day visit
|
Internal consistency - item-total correlations
Time Frame: Single 1 day visit
|
Item-total correlations for each FLORA-20 task
|
Single 1 day visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Uday Patel, PhD, Second Sight Medical Products, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2020
Primary Completion (Estimated)
December 8, 2024
Study Completion (Estimated)
February 20, 2025
Study Registration Dates
First Submitted
March 16, 2020
First Submitted That Met QC Criteria
March 17, 2020
First Posted (Actual)
March 18, 2020
Study Record Updates
Last Update Posted (Estimated)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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