Binocular Vision DisorderESPPADONNCT02651389
Evaluation of Tests Performance on a New Digital Orthoptic Platform
An observational study of Binocular Vision Disorder and Visual Impairment, run by University Hospital, Brest at 1 site in France.
Trial summary
This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Binocular Vision Disorder, Visual Impairment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2016to 29 Sep 2016
- Phase
- Observational
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People performing an orthoptic exam at ophthalmology department of Brest University Hospital.
Who may be able to join
- Patients with less than or equal to 16 ocular deviation prism diopters, without or with slight amblyopia (maximum difference of 2 logarithmic visual acuity lines) and performing an orthoptic exam at ophthalmology department of Brest University Hospital.
Who cannot join
- monophthalmic
- Medium and deep amblyopic patients
- Patients with not normal ocular motility
- Patient who underwent surgery at the head and neck during the previous three months
- Children under 7 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation de la Performance d'Une Nouvelle Plateforme de Tests de dépistage Orthoptique numériques
This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.
Read the detailed description
The demography of ophthalmologists is becoming weaker, many tasks are now performed by orthoptists. To optimize the achievement of orthoptic exams and thus make reliable screening in a shorter time, digital tools are developed. They attempt to renew the orthoptic screening equipment that is still made up of numerous tests, often with old designs that must be handled and adapted to each patient which constitutes a significant loss of time.
It therefore appeared necessary for us to develop a platform of digital tools that integrates major tests used for diagnostic purposes, especially a visual acuity test, a stereoscopic vision test, a fusion test and a digital synoptophore enabling a detailed analysis of disorders of binocular vision.
The purpose of the study is to evaluate this new tool, avoiding the mobilization of patients , and quantify whether this platform is precise, reliable, fast, comfortable and allow the realization of a safe examination for the patient and for orthoptics.
- Conditions
- Binocular Vision Disorder, Visual Impairment
- Keywords
- Digital Orthoptic Platform, Vision test
- Medical subject headings
- Vision Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Ocular Convergence as Measured by the Two Machines
Measured: through study completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start18 Feb 2016
- Primary completion29 Sep 2016
- Study completion29 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binocular Vision DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béatrice Cochener, Pr, Principal investigator, University Hospital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651389
- Sponsor's protocol ID
- RB 15.087 - ESPPADON
- Acronym
- ESPPADON
- Status last verified
- Apr 2017
- First submitted
- 29 Dec 2015
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de la Performance d'Une Nouvelle Plateforme de Tests de dépistage Orthoptique numériques
- ClinicalTrials.gov ID
- NCT02651389
- Acronym / sponsor ID
- ESPPADON / RB 15.087 - ESPPADON
- Conditions
- Binocular Vision Disorder, Visual Impairment
- Keywords
- Digital Orthoptic Platform, Vision test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 29 Sep 2016 (actual)
- Study completion
- 29 Sep 2016 (actual)
- First posted
- 11 Jan 2016 (estimated)
- 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 clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.
Detailed description
The demography of ophthalmologists is becoming weaker, many tasks are now performed by orthoptists. To optimize the achievement of orthoptic exams and thus make reliable screening in a shorter time, digital tools are developed. They attempt to renew the orthoptic screening equipment that is still made up of numerous tests, often with old designs that must be handled and adapted to each patient which constitutes a significant loss of time.
It therefore appeared necessary for us to develop a platform of digital tools that integrates major tests used for diagnostic purposes, especially a visual acuity test, a stereoscopic vision test, a fusion test and a digital synoptophore enabling a detailed analysis of disorders of binocular vision.
The purpose of the study is to evaluate this new tool, avoiding the mobilization of patients , and quantify whether this platform is precise, reliable, fast, comfortable and allow the realization of a safe examination for the patient and for orthoptics.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People performing an orthoptic exam at ophthalmology department of Brest University Hospital.
Key inclusion criteria (1 listed)
- Patients with less than or equal to 16 ocular deviation prism diopters, without or with slight amblyopia (maximum difference of 2 logarithmic visual acuity lines) and performing an orthoptic exam at ophthalmology department of Brest University Hospital.
Key exclusion criteria (5 listed)
- monophthalmic
- Medium and deep amblyopic patients
- Patients with not normal ocular motility
- Patient who underwent surgery at the head and neck during the previous three months
- Children under 7 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of Ocular Convergence as Measured by the Two Machines
Time frame: through study completion, an average of 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Béatrice Cochener, Pr principal investigator
University Hospital of Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Binocular Vision Disorder and Visual Impairment, run by University Hospital, Brest at 1 site 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of Ocular Convergence as Measured by the Two Machines (time frame: through study completion, an average of 1 hour). 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 14 Apr 2017.