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

Low Vision Clinical Trial

— VISIONUM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03353727
• Other study ID #: JGS_2016_25
• Status: Terminated
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: October 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low Vision
• Vision, Low

Intervention

Other:
• Orthoptic rehabilitation
Orthoptic rehabilitation using innovative mechanisms (eye tracker and tactile device) for low vision people

Locations

Country	Name	City	State
France	Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts	Paris
France	Fondation Hospitalière Sainte Marie	Paris
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	score assessing the feasibility of the rehabilitation	System Usability Scale score	18 months after inclusion