Eye DiseasesNCT04185701
Comparison of Subjective Refraction Measurement With SiVIEW Software and by an Expert
A study testing SiVIEW software and Expert in people with Eye Diseases and Ametropia, run by SiVIEW at 1 site in France.
Trial summary
Main objective Show that the equivalent sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases, Ametropia
- What is being tested?
- SiVIEW software and Expert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2022to 15 Jun 2023
- 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
- subject with visual AV on each eye >= 8/10 and no amblyopia
- subject with normal environmental transparency
- subject with a healthy fundus that does not reveal major abnormalities that may affect vision
- subject able to read the letters of the Latin alphabet
- subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids
- non-diabetic subject
Show all 9Show fewer
- non nystagmic subject
- non-strabic subject
- subject who has not had eye surgery less than 1 year old
Who cannot join
- subject with a topography showing an anomaly (keratoconus type or other)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Subjective Refraction Measured With SiVIEW Software Compared to That Obtained Manually by an Expert. Monocentric Cross-sectional Study
Main objective
Show that the equivalent sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Read more
Secondary objectives
Show that the sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the cylinder refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the visual acuity measurements obtained by the SiVIEW software do not have a significant clinical difference with those obtained by an optometrist expert.
Demonstrate that the report delivered for each eye exam by SiVIEW software is consistent and relevant to a vision health practitioner.
Show that the differences obtained between two eye examination experts are consistent with those found in the literature.
Read the detailed description
Introduction:
Ametropia is an eye refractive disorder typically leading to myopia, hyperopia, astigmatism... 4.5 billion people are currently affected worldwide, of whom only 2 billion are corrected. Of these people, about 30% (or +/- 600,000) do not benefit from an adequate correction. From an economic point of view, the cost on productivity of the absence or poor vision correction is estimated at more than 270 billion euros / year worldwide.
Any correction of an ametropic disorder necessarily requires a precise and relevant eye examination in order to identify the disorder and determine the best possible visual correction. The procedure for this examination is identical in all countries. It must follow specific steps[Benjamin 2006; Grosvenor 2007].
At present the refraction measurement is done manually by an expert. The optical correction may vary from one examination to another, for multiple physiological and/or examination-related reasons. Several factors can cause fluctuations in subjective refraction. These include examiner and subject characteristics [Grein et al. 2014].
In addition, there is also variability due to the measurement itself, depending on each examiner. The repeatability (on the same subject) and, in addition, the reproducibility (inter-examiners) of the subjective refraction measurement related to the examiner's interpretation, examination process and experience, among other things, are therefore important data to be defined in order to know the tolerance of the measurement determined between two examinations.
In studies involving a large number of subjects, the repeatability/reproducibility limit is greater than or equal to 0.71D [Zadnik 1994, Bullimore 1998, MacKenzie 2008], and more particularly during inter-examiner measurements.
The objective of the SiVIEW solution is therefore to make the measurement of subjective refraction both repeatable and reproducible regardless of the practitioner and his expertise, by completely automating the search for the best visual prescription using an expert system that aims to make this examination simple, intuitive and reliable.
It is therefore essential to compare the SiVIEW measurement with that of an optometrist expert.
The interest of the investigator's study will be to demonstrate that the results between a refraction expert and the measurement obtained by SiVIEW are clinically similar.
Main objective:
Show that the equivalent sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Secondary objectives
Show that the sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the cylinder refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the visual acuity measurements obtained by the SiVIEW software do not have a significant clinical difference with those obtained by an optometrist expert.
Demonstrate that the report delivered for each eye exam by SiVIEW software is consistent and relevant to a vision health practitioner.
Show that the differences obtained between two eye examination experts are consistent with those found in the literature.
Plan of the study:
It is a comparative prospective open monocentric cross-sectionnal study.
- Conditions
- Eye Diseases, Ametropia
- Being tested
- SiVIEW software, Expert
- Keywords
- automatic sphere measurements, eye examination, ametropia
- Medical subject headings
- Eye Diseases, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiVIEW softwareOther
Eye examination by a technician with the SiVIEW software
ExpertOther
Eye examination by an expert including optimal correction in distance and near vision
| Study group | Role | What they receive |
|---|---|---|
| Eye examination by expert and SiVIEW software | Experimental | Eye examination by an expert and by a technician with the SiVIEW system. Receives: Other: SiVIEW software; Other: Expert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalent sphere measurement
The subject will have an eye exam with SiVIEW and an examination by an optometrist expert. The equivalent sphere value will be evaluated in both cases.
Measured: At time of inclusion
Secondary outcomes (5)
Sphere measurement
The subject will have an eye exam performed with SiVIEW and by an optometrist expert. The sphere value will be evaluated in both cases. The examination will be started in both cases on the objective measurement value obtained during the routine care examination.
Measured: At time of inclusion
Cylinder measurement
The subject will have an eye exam performed with SiVIEW and by an optometrist expert. The cylinder value will be evaluated in both cases. The examination will be started in both cases on the objective measurement value obtained during the routine care examination.
Measured: At time of inclusion
Visual acuity
The subject will have an eye exam performed with SiVIEW and by an optometrist expert. The value of visual acuity will be assessed in both cases.
Measured: At time of inclusion
Consistency and relevance of the SiVIEW report
After each examination, the report edited by the SiVIEW software will be scored consistently on a Likert scale from 1 to 5 by an expert optometrist:
1: very inconsistent / 2: inconsistent / 3: no opinion / 4: consistent / 5: very consistent
After each examination, the report edited by SiVIEW software will be scored in relevance on a 5 item Likert scale by an expert optometrist:
1: not relevant / not very relevant / no opinion / relevant / very relevant.
Measured: At time of inclusion
Measurement between two optometrist experts
Each subject will have an eye examination conducted with an optometrist from the current care centre and by an optometrist expert mandated by SiVIEW (who is used to working at the Rothschild Foundation in clinical studies, among others). The equivalent sphere value will be evaluated in both cases.
Measured: At time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Nov 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- * Eye examination by an expert including optimal correction in distance and near vision * Eye examination by a technician with the SiVIEW system * Analysis of the SiVIEW report by the expert who conducted the second review
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- SiVIEW
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damien Gatinel, MD, Principal investigator, Head of Department Ophthalmological Foundation A. de Rothschild, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185701
- Sponsor's protocol ID
- SiVIEW_refraction_Paris_study
- Status last verified
- Mar 2023
- First submitted
- 30 Nov 2019
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Subjective Refraction Measured With SiVIEW Software Compared to That Obtained Manually by an Expert. Monocentric Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04185701
- Acronym / sponsor ID
- SiVIEW_refraction_Paris_study
- Conditions
- Eye Diseases, Ametropia
- Keywords
- automatic sphere measurements, eye examination, ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- SiVIEWIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 4 Dec 2019 (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.
Main objective
Show that the equivalent sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Secondary objectives
Show that the sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the cylinder refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the visual acuity measurements obtained by the SiVIEW software do not have a significant clinical difference with those obtained by an optometrist expert.
Demonstrate that the report delivered for each eye exam by SiVIEW software is consistent and relevant to a vision health practitioner.
Show that the differences obtained between two eye examination experts are consistent with those found in the literature.
Detailed description
Introduction:
Ametropia is an eye refractive disorder typically leading to myopia, hyperopia, astigmatism... 4.5 billion people are currently affected worldwide, of whom only 2 billion are corrected. Of these people, about 30% (or +/- 600,000) do not benefit from an adequate correction. From an economic point of view, the cost on productivity of the absence or poor vision correction is estimated at more than 270 billion euros / year worldwide.
Any correction of an ametropic disorder necessarily requires a precise and relevant eye examination in order to identify the disorder and determine the best possible visual correction. The procedure for this examination is identical in all countries. It must follow specific steps[Benjamin 2006; Grosvenor 2007].
At present the refraction measurement is done manually by an expert. The optical correction may vary from one examination to another, for multiple physiological and/or examination-related reasons. Several factors can cause fluctuations in subjective refraction. These include examiner and subject characteristics [Grein et al. 2014].
In addition, there is also variability due to the measurement itself, depending on each examiner. The repeatability (on the same subject) and, in addition, the reproducibility (inter-examiners) of the subjective refraction measurement related to the examiner's interpretation, examination process and experience, among other things, are therefore important data to be defined in order to know the tolerance of the measurement determined between two examinations.
In studies involving a large number of subjects, the repeatability/reproducibility limit is greater than or equal to 0.71D [Zadnik 1994, Bullimore 1998, MacKenzie 2008], and more particularly during inter-examiner measurements.
The objective of the SiVIEW solution is therefore to make the measurement of subjective refraction both repeatable and reproducible regardless of the practitioner and his expertise, by completely automating the search for the best visual prescription using an expert system that aims to make this examination simple, intuitive and reliable.
It is therefore essential to compare the SiVIEW measurement with that of an optometrist expert.
The interest of the investigator's study will be to demonstrate that the results between a refraction expert and the measurement obtained by SiVIEW are clinically similar.
Main objective:
Show that the equivalent sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Secondary objectives
Show that the sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the cylinder refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the visual acuity measurements obtained by the SiVIEW software do not have a significant clinical difference with those obtained by an optometrist expert.
Demonstrate that the report delivered for each eye exam by SiVIEW software is consistent and relevant to a vision health practitioner.
Show that the differences obtained between two eye examination experts are consistent with those found in the literature.
Plan of the study:
It is a comparative prospective open monocentric cross-sectionnal study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Eye examination by an expert including optimal correction in distance and near vision * Eye examination by a technician with the SiVIEW system * Analysis of the SiVIEW report by the expert who conducted the second review
| Arm | Type | Receives |
|---|---|---|
| Eye examination by expert and SiVIEW software | Experimental | Other: SiVIEW software, Other: ExpertEye examination by an expert and by a technician with the SiVIEW system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- subject with visual AV on each eye >= 8/10 and no amblyopia
- subject with normal environmental transparency
- subject with a healthy fundus that does not reveal major abnormalities that may affect vision
- subject able to read the letters of the Latin alphabet
- subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids
Key exclusion criteria (1 listed)
- subject with a topography showing an anomaly (keratoconus type or other)
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 |
|---|---|---|
| SiVIEW softwareEye examination by a technician with the SiVIEW software | Other | Eye examination by expert and SiVIEW software |
| ExpertEye examination by an expert including optimal correction in distance and near vision | Other | Eye examination by expert and SiVIEW software |
Primary outcome
Equivalent sphere measurement
Time frame: At time of inclusion
The subject will have an eye exam with SiVIEW and an examination by an optometrist expert. The equivalent sphere value will be evaluated in both cases.
5 secondary outcomes
Sphere measurement
Time frame: At time of inclusion
Cylinder measurement
Time frame: At time of inclusion
Visual acuity
Time frame: At time of inclusion
Consistency and relevance of the SiVIEW report
Time frame: At time of inclusion
Measurement between two optometrist experts
Time frame: At time of inclusion
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 24 Nov 2023.
- 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.
Damien Gatinel, MD principal investigator
Head of Department Ophthalmological Foundation A. de Rothschild, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SiVIEW software and Expert in people with Eye Diseases and Ametropia, run by SiVIEW 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 9 inclusion and 1 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 24 Nov 2023. 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?
Equivalent sphere measurement (time frame: At time of 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 24 Nov 2023.