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TerminatedNCT03353727VISIONUMUpdated Feb 19, 2019

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

An interventional study of Orthoptic rehabilitation in Low Vision, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Terminated at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Other

Why this study was terminated
lack of Financial support

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2017, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Low Vision

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Keywords

  • Orthoptic rehabilitation
  • low vision
  • eye tracker
  • tactile device
03

In context

Vision, Low

98 studies on the registry are indexed under Vision, Low; 23 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 78 interventional studies indexed under Vision, Low.

Browse Vision, Low studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Medical treatment that may interfere with the study
  • Degenerative diseases or any other diseases that may interfere with the study.
  • Score without visual item ≤ 20/25
  • Pregnancy and lactation.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Orthoptic rehabilitation

    Other: Orthoptic rehabilitation

Interventions

  • OtherOrthoptic rehabilitation

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

06

What researchers measure

Primary outcomes

  1. score assessing the feasibility of the rehabilitation

    System Usability Scale score

    Time frame: 18 months after inclusion

07

Study locations

3 sites
  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
    Paris, 75012, France
  • Fondation Hospitalière Sainte Marie
    Paris, 75014, France
  • Fondation Ophtalmologique Adolphe de Rothschild
    Paris, 75019, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in Dec 2018, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2017
First posted
Nov 27, 2017
StartActual
Jun 20, 2017
Primary completionActual
Dec 20, 2018
CompletionActual
Dec 20, 2018
Last update
Feb 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03353727
Responsible party
Sponsor
First posted
Nov 27, 2017
Start date
Jun 20, 2017
Primary completion
Dec 20, 2018
Completion
Dec 20, 2018
Last update
Feb 19, 2019

Study contacts

Jean-François Girmens, MD
principal investigator · Centre Hospitalier National d'Ophtalmologie des Quinze Vingts, Paris

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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