MyopiaMDSW_DiVA2RxNCT07297810
Development of a New Device and Method to Assess the Degree of Myopia and/or Astigmatism in Myopic People
A study testing Optical correction values obtained with investigational device and visual acuity, Optical correction values obtained with an autorefractometer and visual acuity and Optical correction values obtained with a phoropter and visual acuity in people with Myopia, run by Essilor International at 1 site in France.
Trial summary
The purpose of this clinical investigation is to check whether the new device can correctly measure a person's degree of myopia and astigmatism. To evaluate and improve the device's performance, the results (optical correction values and the associated visual acuity) obtained with the investigational device will be… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Optical correction values obtained with investigational device and visual acuity, Optical correction values obtained with an autorefractometer and visual acuity and Optical correction values obtained with a phoropter and visual acuity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
- Aged between 18 and 39 years at the time of study inclusion
- Wear corrective glasses
- With an ophthalmologist's prescription for corrective eyewear less than 3 years old
- Spherical error of each meridian within the range of [-5.00 ; -0.50 D]
- Cylindrical defect included in interval [-4.50 ; 0.00 D]
- Corrected monocular visual acuity ≤ 0.0 logMAR for distance vision (≥10/10)
- French Social Security beneficiary
Who cannot join
- General criteria for non-inclusion:
- Essilor International employee
- Pregnant, or breast-feeding women (Article L1121-5)
- Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research
- Adults incapable or unable to express consent (Article L1121-8)
- Participant included in another ongoing study or in a period of exclusion
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- All categories of persons particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the French Public Health Code)
- Amblyopia, strabismus, nystagmus
- Wearing progressive lenses
- The following elements are considered based on the participant's declaration :
- Declared cataract, Aphakia (without lens) or pseudophakia (with intraocular implant)
- Ocular surgery (iridectomy, refractive surgery, corneal transplant)
- Ocular trauma (corneal deformation, contusion, chemical burn, foreign body intrusion, perforation, orbital fracture, enucleation)
- Severe ocular pathology, involving loss of visual field as in glaucoma or retinitis pigmentosa, involving loss of acuity and severe discomfort in dimly or brightly lit environments as in Age related macular degeneration (AMD) or overt and treated dry eye.
- Systemic pathology affecting vision (diabetes, uncontrolled blood pressure, myasthenia gravis, etc.).
- Medication that may affect vision or interfere with study measures (antidepressants, medication with atropine-like effects).
- Declared neurological deficits, in particular a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g. balance disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Essilor International - Ci&T 3
Créteil, France, 94000
Stéphane Boutinon, Master of Engineering, +33 6 77 16 43 83, boutinos@essilor.fr
Amélia Sageat, Optometrist
About this study
Official title: Development of a New Device and Method for Determining Refractive Errors in a Myopic Population
The purpose of this clinical investigation is to check whether the new device can correctly measure a person's degree of myopia and astigmatism.
To evaluate and improve the device's performance, the results (optical correction values and the associated visual acuity) obtained with the investigational device will be compared with the results obtained using standard instruments commonly used by eye care professionals.
- Conditions
- Myopia
- Being tested
- Optical correction values obtained with investigational device and visual acuity, Optical correction values obtained with an autorefractometer and visual acuity, Optical correction values obtained with a phoropter and visual acuity
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical correction values obtained with investigational device and visual acuityDevice
Participants optical correction values are determined using the investigational device and their visual acuity is measured with this optical correction
Optical correction values obtained with an autorefractometer and visual acuityDevice
Participants optical correction values are determined using an autorefractometer (objective refraction) and their visual acuity is measured with this optical correction
Optical correction values obtained with a phoropter and visual acuityDevice
Participants optical correction values are determined using a phoropter (subjective refraction) and their visual acuity is measured with this optical correction
| Study group | Role | What they receive |
|---|---|---|
| Healthy Myopic Non-Presbyopic Adults | Experimental | Not described Receives: Device: Optical correction values obtained with investigational device and visual acuity; Device: Optical correction values obtained with an autorefractometer and visual acuity; Device: Optical correction values obtained with a phoropter and visual acuity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Optical Values
Optical correction values obtained with the investigational device are compared with the values obtained using a phoropter (gold standard method - subjective refraction)
Measured: Day One
Difference in the proportion of visual acuity levels
Comparison of the proportion of participants reaching specific monocular visual acuity levels (≥10/10 and ≥12/10) when wearing the refraction obtained from the investigational device versus the subjective refraction obtained from a phoropter (gold standard method)
Measured: Day One
Secondary outcomes (1)
Comparison of Monocular Visual Acuity Distribution
Comparison of the distribution of monocular visual acuity obtained using the refraction from the investigational device versus the objective refraction from an autorefractometer.
Measured: Day One
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gildas Marin, PhD, Principal investigator, Essilor International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297810
- Sponsor's protocol ID
- WS10408
- Acronym
- MDSW_DiVA2Rx
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Device and Method for Determining Refractive Errors in a Myopic Population
- ClinicalTrials.gov ID
- NCT07297810
- Acronym / sponsor ID
- MDSW_DiVA2Rx / WS10408
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Dec 2025 (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.
The purpose of this clinical investigation is to check whether the new device can correctly measure a person's degree of myopia and astigmatism.
To evaluate and improve the device's performance, the results (optical correction values and the associated visual acuity) obtained with the investigational device will be compared with the results obtained using standard instruments commonly used by eye care professionals.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Myopic Non-Presbyopic Adults | Experimental | Device: Optical correction values obtained with investigational device and visual acuity, Device: Optical correction values obtained with an autorefractometer and visual acuity, Device: Optical correction values obtained with a phoropter and visual acuity |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Volunteers, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
- Aged between 18 and 39 years at the time of study inclusion
- Wear corrective glasses
- With an ophthalmologist's prescription for corrective eyewear less than 3 years old
- Spherical error of each meridian within the range of [-5.00 ; -0.50 D]
Key exclusion criteria (17 listed)
- Essilor International employee
- Pregnant, or breast-feeding women (Article L1121-5)
- Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research
- Adults incapable or unable to express consent (Article L1121-8)
- Participant included in another ongoing study or in a period of exclusion
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 |
|---|---|---|
| Optical correction values obtained with investigational device and visual acuityParticipants optical correction values are determined using the investigational device and their visual acuity is measured with this optical correction | Device | Healthy Myopic Non-Presbyopic Adults |
| Optical correction values obtained with an autorefractometer and visual acuityParticipants optical correction values are determined using an autorefractometer (objective refraction) and their visual acuity is measured with this optical correction | Device | Healthy Myopic Non-Presbyopic Adults |
| Optical correction values obtained with a phoropter and visual acuityParticipants optical correction values are determined using a phoropter (subjective refraction) and their visual acuity is measured with this optical correction | Device | Healthy Myopic Non-Presbyopic Adults |
Primary outcome
Difference of Optical Values
Time frame: Day One
Optical correction values obtained with the investigational device are compared with the values obtained using a phoropter (gold standard method - subjective refraction)
Difference in the proportion of visual acuity levels
Time frame: Day One
Comparison of the proportion of participants reaching specific monocular visual acuity levels (≥10/10 and ≥12/10) when wearing the refraction obtained from the investigational device versus the subjective refraction obtained from a phoropter (gold standard method)
1 secondary outcome
Comparison of Monocular Visual Acuity Distribution
Time frame: Day One
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- 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.
Gildas Marin, PhD principal investigator
Essilor International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical correction values obtained with investigational device and visual acuity, Optical correction values obtained with an autorefractometer and visual acuity and Optical correction values obtained with a phoropter and visual acuity in people with Myopia, run by Essilor International 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 8 inclusion and 17 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: opening soon, as of the sponsor's last update on 22 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Boutinon, Master of engineering (+33 6 77 16 43 83, boutinos@essilor.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Optical Values (time frame: Day One). The study lists 2 primary outcomes in all. 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 22 Dec 2025.