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Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population

NCT04725760 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2021-11-10

No results posted yet for this study

Summary

The purpose of the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light perception or less in both eyes.

Conditions

Interventions

DEVICE

BrainPort Vision Pro

Ten hours of training over 3 to 5 days, followed by autonomous use of the device. It will be recommended that the subject use the BrainPort® Vision Pro device for at least 5 hours per month for a period of 12 months.

Sponsors & Collaborators

  • Wicab

    lead INDUSTRY

Principal Investigators

  • Patricia Grant, Ph.D. · Wicab, Inc.

  • Isabelle Audo, Ph.D. · National Hospital for Ophthalmology of the Fifteen-Vingts

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-09-30
Completion
2022-09-30
FDA Device
Yes

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04725760 on ClinicalTrials.gov