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

  • United States
    • California
      • Sylmar, California, United States, 91342
        • Second Sight Medical Products, Inc.

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

Second Sight Medical Products

Collaborators

Boston Biomedical Associates

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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