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

Primary Purpose

Low Vision

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Orthoptic rehabilitation
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Vision focused on measuring Orthoptic rehabilitation, low vision, eye tracker, tactile device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
  • Fondation Hospitalière Sainte Marie
  • Fondation Ophtalmologique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orthoptic rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

score assessing the feasibility of the rehabilitation
System Usability Scale score

Secondary Outcome Measures

Full Information

First Posted
October 25, 2017
Last Updated
February 18, 2019
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT03353727
Brief Title
Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)
Acronym
VISIONUM
Official Title
Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
lack of Financial support
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Vision
Keywords
Orthoptic rehabilitation, low vision, eye tracker, tactile device

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orthoptic rehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Orthoptic rehabilitation
Intervention Description
Orthoptic rehabilitation using innovative mechanisms (eye tracker and tactile device) for low vision people
Primary Outcome Measure Information:
Title
score assessing the feasibility of the rehabilitation
Description
System Usability Scale score
Time Frame
18 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François Girmens, MD
Organizational Affiliation
Centre Hospitalier National d'Ophtalmologie des Quinze Vingts, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Fondation Hospitalière Sainte Marie
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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

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