StrabismusFREGMANCT03596138
Reliability and Reproducibility of Automated Angular Measurement in Strabismus
An observational study of Strabismus, run by Nantes University Hospital at 1 site in France.
Trial summary
Angular measurement of deviation is an essential element in the clinical evaluation of strabic patients. It is performed by orthoptic methods. However, studies show that the same patient presents a great variability of his angular measurement between 2 consultations, and between 2 observers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strabismus
- What is being tested?
- Evaluate the reliability and reproductibility of the automated angular measurement by the Gazelab
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2018to 29 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Strabismus is a pathology that affects 2 to 4% of the French population. The Ophthalmology Department sees 200 adult patients with strabismus per month. In 6 months it will be easy to include in 30 months 30 patients of convergent strabismus and 30 of divergent strabismus. For patients with eye strain who do not have eye refractive errors the Department of Ophthalmology sees 2000 patients per month, to include these 30 patients in 6 months. Since this study is a prospective non-interventional research study, the patient may be part of a biomedical research study.
Who may be able to join
- Patients over 18 years of age
- Strabic convergent or divergent patients or patients requiring an oculomotor check-up in their follow-up consultation
- Patient giving oral consent to this study
Who cannot join
- Patient with medical follow-up impossible,
- Impossibility to install Gazelab equipment for anatomical reasons of the head (craniostenosis...)
- No ocular fixation.
- Major without freedom under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
About this study
Angular measurement of deviation is an essential element in the clinical evaluation of strabic patients. It is performed by orthoptic methods. However, studies show that the same patient presents a great variability of his angular measurement between 2 consultations, and between 2 observers.
Automated angle measurement is a recent concept that aims to overcome the defects of subjective angle measurement by alternate occlusion test and prismatic bar.
Read more
Improvements made by these devices would provide reliable, objective and reproducible measurements of the angle of deviation by increasing the accuracy of strabal angle assessment, improving decision making and surgical follow-up, decreasing inter-examiner variability and variability over time, and facilitating data comparison to improve scientific publication possibilities.
The Gazelab® device is a video-oculograph combined with a laser projection system and an infrared camera. It allows an objective angular evaluation, in non-dissociating physiological conditions, possible even in the absence of binocular vision and allows an analysis of the deviation in all positions.
There is extremely little data in the literature on automated measuring devices. The Gazelab tool is still little known in the strabology discipline and seems to have a number of advantages over other devices. The interest of this examination towards this pathology led the ophthalmology department to use it in the current practice, and since recently it is an act nomenclaturé.
Read the detailed description
The objective of this work is to evaluate the reliability and reproducibility of the automated angular measurement by the Gazelab® (ES12/13127) apparatus, compared to the standard gold which is the angular measurement by alternate occlusion test and prismatic bar, in horizontal strabisms (converging and diverging). Indeed in our daily practice the 2 examinations are carried out. To compare with the standard gold which denotes a strong inter-observer variability, the investigator will compare the results of the Gazelab to the alternate occlusion by prism bar (standard gold) 2 times with 2 trained examiners
- Conditions
- Strabismus
- Being tested
- Evaluate the reliability and reproductibility of the automated angular measurement by the Gazelab
- Keywords
- angle measurement, automated, strabismus
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the reliability and reproductibility of the automated angular measurement by the GazelabOther
Compare the results of the Gazelab to the alternate occlusion by prism bar (standard gold) examiners.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-class correlation coefficient
Intra-class correlation coefficient calculated on the 4 measures (2 of each technique) of each patient taken at time 1 by the same assessor.
Measured: 12 months
Secondary outcomes (2)
Intra-class correlation coefficient using measurements
Intra-class correlation coefficient using measurements from each technique between 2 different evaluators at time 1
Measured: 12 months
Intraclass correlation coefficient using time 1 and time 2 measurements
Intraclass correlation coefficient using time 1 and time 2 measurements with the same investigator
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start4 Sep 2018
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre LEBRANCHU, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596138
- Sponsor's protocol ID
- RC18_0062
- Acronym
- FREGMA
- Status last verified
- Nov 2022
- First submitted
- 10 Jul 2018
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Reproducibility of Automated Angular Measurement in Strabismus
- ClinicalTrials.gov ID
- NCT03596138
- Acronym / sponsor ID
- FREGMA / RC18_0062
- Conditions
- Strabismus
- Keywords
- angle measurement, automated, strabismus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 23 Jul 2018 (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.
Angular measurement of deviation is an essential element in the clinical evaluation of strabic patients. It is performed by orthoptic methods. However, studies show that the same patient presents a great variability of his angular measurement between 2 consultations, and between 2 observers.
Automated angle measurement is a recent concept that aims to overcome the defects of subjective angle measurement by alternate occlusion test and prismatic bar.
Improvements made by these devices would provide reliable, objective and reproducible measurements of the angle of deviation by increasing the accuracy of strabal angle assessment, improving decision making and surgical follow-up, decreasing inter-examiner variability and variability over time, and facilitating data comparison to improve scientific publication possibilities.
The Gazelab® device is a video-oculograph combined with a laser projection system and an infrared camera. It allows an objective angular evaluation, in non-dissociating physiological conditions, possible even in the absence of binocular vision and allows an analysis of the deviation in all positions.
There is extremely little data in the literature on automated measuring devices. The Gazelab tool is still little known in the strabology discipline and seems to have a number of advantages over other devices. The interest of this examination towards this pathology led the ophthalmology department to use it in the current practice, and since recently it is an act nomenclaturé.
Detailed description
The objective of this work is to evaluate the reliability and reproducibility of the automated angular measurement by the Gazelab® (ES12/13127) apparatus, compared to the standard gold which is the angular measurement by alternate occlusion test and prismatic bar, in horizontal strabisms (converging and diverging). Indeed in our daily practice the 2 examinations are carried out. To compare with the standard gold which denotes a strong inter-observer variability, the investigator will compare the results of the Gazelab to the alternate occlusion by prism bar (standard gold) 2 times with 2 trained examiners
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Strabismus is a pathology that affects 2 to 4% of the French population. The Ophthalmology Department sees 200 adult patients with strabismus per month. In 6 months it will be easy to include in 30 months 30 patients of convergent strabismus and 30 of divergent strabismus. For patients with eye strain who do not have eye refractive errors the Department of Ophthalmology sees 2000 patients per month, to include these 30 patients in 6 months. Since this study is a prospective non-interventional research study, the patient may be part of a biomedical research study.
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Strabic convergent or divergent patients or patients requiring an oculomotor check-up in their follow-up consultation
- Patient giving oral consent to this study
Key exclusion criteria (4 listed)
- Patient with medical follow-up impossible,
- Impossibility to install Gazelab equipment for anatomical reasons of the head (craniostenosis...)
- No ocular fixation.
- Major without freedom under guardianship or trusteeship
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 |
|---|---|---|
| Evaluate the reliability and reproductibility of the automated angular measurement by the GazelabCompare the results of the Gazelab to the alternate occlusion by prism bar (standard gold) examiners. | Other | – |
Primary outcome
Intra-class correlation coefficient
Time frame: 12 months
Intra-class correlation coefficient calculated on the 4 measures (2 of each technique) of each patient taken at time 1 by the same assessor.
2 secondary outcomes
Intra-class correlation coefficient using measurements
Time frame: 12 months
Intraclass correlation coefficient using time 1 and time 2 measurements
Time frame: 12 months
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 25 Nov 2022.
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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.
Pierre LEBRANCHU, Dr principal investigator
Nantes University Hospital
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 Strabismus, run by Nantes University Hospital 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 3 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: finished, as of the sponsor's last update on 25 Nov 2022. 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?
Intra-class correlation coefficient (time frame: 12 months). 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 25 Nov 2022.