Low VisionVISIONUMNCT03353727
Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)
A study testing Orthoptic rehabilitation in people with Low Vision, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Vision
- What is being tested?
- Orthoptic rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Jun 2017to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Fondation Hospitalière Sainte Marie
Paris, 75014
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
About this study
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
- Being tested
- Orthoptic rehabilitation
- Keywords
- Orthoptic rehabilitation, low vision, eye tracker, tactile device
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthoptic rehabilitationOther
Orthoptic rehabilitation using innovative mechanisms (eye tracker and tactile device) for low vision people
| Study group | Role | What they receive |
|---|---|---|
| Orthoptic rehabilitation | Experimental | Not described Receives: Other: Orthoptic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
score assessing the feasibility of the rehabilitation
System Usability Scale score
Measured: 18 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start20 Jun 2017
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Why it stopped: lack of Financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low VisionStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-François Girmens, MD, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze Vingts, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353727
- Sponsor's protocol ID
- JGS_2016_25
- Acronym
- VISIONUM
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)
- ClinicalTrials.gov ID
- NCT03353727
- Acronym / sponsor ID
- VISIONUM / JGS_2016_25
- Conditions
- Low Vision
- Keywords
- Orthoptic rehabilitation, low vision, eye tracker, tactile device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of Financial support
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthoptic rehabilitation | Experimental | Other: Orthoptic rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthoptic rehabilitationOrthoptic rehabilitation using innovative mechanisms (eye tracker and tactile device) for low vision people | Other | Orthoptic rehabilitation |
Primary outcome
score assessing the feasibility of the rehabilitation
Time frame: 18 months after inclusion
System Usability Scale score
Results and safety
The study was stopped early (reason given: lack of Financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Girmens, MD principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze Vingts, Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthoptic rehabilitation in people with Low Vision, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of Financial support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score assessing the feasibility of the rehabilitation (time frame: 18 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.