Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2018-06-20

Brief Summary

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The goal of the current project is to fill the unmet clinical needs around the objective assessment of visual function and develop outcome-oriented visual rehabilitation approach using the computer assisted rehabilitation environment (CAREN) system for Argus recipients.

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Detailed Description

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Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAREN system training

CAREN training

Group Type EXPERIMENTAL

CAREN system training

Intervention Type DEVICE

CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.

Interventions

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CAREN system training

CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Recipient of the Argus II Retinal Prosthesis System
* Ability to provide informed consent
* Ability to follow two-step commands
* Ability to ambulate 300+ feet with or without visual assistance
* Able to tolerate Argus device turned on for \>20 continuous minutes.

Exclusion Criteria

* Dementia
* Musculoskeletal contraindication to exercise or walking
* Cardiopulmonary contraindication exercise (i.e. uncontrolled heart failure, cardiac arrhythmia, or pulmonary disease).

Minimum Eligible Age

25 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No