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

NCT ID: NCT04312763

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-06

Study Completion Date

2025-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Blindness, Acquired

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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).
Minimum Eligible Age

22 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Biomedical Associates

OTHER

Sponsor Role collaborator

Second Sight Medical Products

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uday Patel, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Sight Medical Products, Inc.

Locations

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Second Sight Medical Products, Inc.

Sylmar, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP-11

Identifier Type: -

Identifier Source: org_study_id