Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device) (VISIONUM)

February 18, 2019 updated by: Fondation Ophtalmologique Adolphe de Rothschild

This project is working on orthoptic rehabilitation for low vision people. The aim of the project is to assess the interest and integration of this rehabilitation device used at home, in low-vision private practice and at the hospital. It leads to develop and evaluate an innovative device to integrate and adjust monitoring of patients according to their need and their progress, to create new interactions with the patient, enabling the orthoptist to stay in touch with his patient at home between rehabilitation sessions and to obtain a more fine and objective analysis of the exercises done by the patient.

Using an eye tracker and a digital tactile screen with data uploads allows the practitioner to observe the progress objectively. It also leads the patient to a better understanding of his/her visual behavior and of the effects of rehabilitation. Therefore, it will be easier to adopt better strategies.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Paris, France, 75012
        • Centre hospitalier National d'Ophtalmologie des Quinze-Vingts
      • Paris, France, 75014
        • Fondation Hospitalière Sainte Marie

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suffering from visual impairment, with a need for visual rehabilitation
  • Visual acuity (≤1.3 logMAR)
  • Good knowledge of French language
  • Informed consent of research

Exclusion Criteria:

  • Medical treatment that may interfere with the study
  • Degenerative diseases or any other diseases that may interfere with the study.
  • Mini-Mental State Examination Score without visual item ≤ 20/25
  • Pregnancy and lactation.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orthoptic rehabilitation
Other: Orthoptic rehabilitation
Orthoptic rehabilitation using innovative mechanisms (eye tracker and tactile device) for low vision people

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score assessing the feasibility of the rehabilitation
Time Frame: 18 months after inclusion
System Usability Scale score
18 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Jean-François Girmens, MD, Centre Hospitalier National d'Ophtalmologie des Quinze Vingts, Paris

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)

June 20, 2017

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JGS_2016_25

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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