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

NCT03353727 | Terminated

• 1 other identifier: JGS_2016_25
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Low Vision

Keywords

Orthoptic rehabilitation; low vision; eye tracker; tactile device

Outcome Measures

Primary Outcomes (1)

• score assessing the feasibility of the rehabilitation

  System Usability Scale score

  18 months after inclusion

Study Arms (1)

Orthoptic rehabilitation

EXPERIMENTAL

Other: Orthoptic rehabilitation

Interventions

Orthoptic rehabilitation OTHER

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

Orthoptic rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (3)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

Location

Fondation Hospitalière Sainte Marie

Paris, 75014, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-François Girmens, MD

  Centre Hospitalier National d'Ophtalmologie des Quinze Vingts, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 27, 2017
• Study Start: June 20, 2017
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: February 19, 2019

Record last verified: 2017-10

Locations

FR (3)