MyopiaOPTIMANCT07804043
Efficacy of Myopia-control Lenses in a Population of Young Adults : the OPTIMA Study
A study testing Essilor® Stellest® 2.0 myopia-slowing lenses and Standard lenses in people with Myopia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The goal of this clinical trial is to learn if myopia-control eyeglass lenses (Essilor® Stellest® 2.0) can slow down the progression of short-sightedness (myopia) in young adults, compared with standard single-vision lenses. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Myopia
- What is being tested?
- Essilor® Stellest® 2.0 myopia-slowing lenses and Standard lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 1 Dec 2030
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Spherical equivalent (SE) measured under cycloplegia using an autorefractometer, within the range 4 D ≤ SE ≤ -0.75 D for each eye
- Not currently receiving, nor having received, any preventive treatment for myopic progression in the 12 months prior to inclusion (orthokeratology, soft defocus contact lenses, low-concentration atropine eye drops, corrective spectacles with peripheral defocus)
- Myopic progression of at least -0.25 D in at least one eye during the year prior to inclusion (measurements documented by autorefractometer, with or without cycloplegia, or via previous optical prescriptions) or documented progression of axial length of +0.1 mm during the year prior to inclusion
- Primary optical correction via spectacles (occasional use of contact lenses if applicable) or agreement to wear spectacles for at least 12 hours a day, every day
- Enrolled in or a beneficiary of a social security scheme
- Signed informed consent to participate in the study by the adult patient or by a person with parental authority for minor patients
Who cannot join
- Confirmed syndromic myopia or findings suggestive of syndromic myopia
- Obvious strabismus or significant heterophoria
- Corrected visual acuity < 8/10 in at least one eye
- A history of eye surgery (excluding eyelid surgery) in at least one eye
- Hyperopia or non-myopic astigmatism
- Anisometropia, i.e. a marked difference in correction between the two eyes
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- Advanced retinal disease in at least one eye, such as myopic maculopathy
- Specific visual impairments in at least one eye requiring personalised treatments other than conventional corrective lenses
- Intolerance to optical corrections (conventional lenses or lenses with peripheral defocus)
- Patients subject to legal protection measures
- Pregnant or breastfeeding women
- Participation in another interventional clinical trial (drug clinical trial)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elise Philippakis contact
Vivien Vasseur contact
About this study
Official title: Efficacité de Verres de Freination Myopique Dans Une Population de Jeunes Adultes
The goal of this clinical trial is to learn if myopia-control eyeglass lenses (Essilor® Stellest® 2.0) can slow down the progression of short-sightedness (myopia) in young adults, compared with standard single-vision lenses. The main questions it aims to answer are:
Does wearing Stellest® 2.0 lenses slow the increase in eye length (axial length) after 1 year, compared with standard lenses? Does wearing Stellest® 2.0 lenses reduce the change in glasses prescription and the occurrence of eye complications after 2 years, compared with standard lenses? How well do participants tolerate the Stellest® 2.0 lenses in the first weeks of wear? Researchers will compare Stellest® 2.0 myopia-control lenses to standard single-vision lenses to see if they reduce the worsening of myopia.
Read more
Participants will:
Wear either the study glasses or standard glasses every day, at least 12 hours a day, for 2 years Attend an eye exam and vision check at the start of the study, after 1 year, and after 2 years Complete three phone check-ins during the first 3 months to report on comfort and how well they tolerate their glasses
- Conditions
- Myopia
- Being tested
- Essilor® Stellest® 2.0 myopia-slowing lenses, Standard lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essilor® Stellest® 2.0 myopia-slowing lensesDevice
Essilor® Stellest® 2.0 myopia-slowing lenses will be worn continuously throughout the day for the two-year follow-up period of the study, i.e. from the time the eyewear (lenses and frames) is dispensed until the end of the follow-up period. It is recommended that the eyewear be worn for at least 12 hours a day, every day.
Standard lensesDevice
Standard lenses (Airwear single-vision lenses) will be worn continuously throughout the day during the two-year follow-up period of the study, i.e. from the time the eyewear (lenses and frames) is issued until the end of the follow-up period. It is recommended that the eyewear be worn for at least 12 hours a day, every day.
| Study group | Role | What they receive |
|---|---|---|
| Essilor® Stellest® 2.0 myopia-slowing lenses | Experimental | Not described Receives: Device: Essilor® Stellest® 2.0 myopia-slowing lenses |
| standard lenses | Active comparator | Not described Receives: Device: Standard lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Axial length measured using the IOL Master® biometer
Measured: 1 year
Secondary outcomes (2)
Spherical equivalent
Spherical equivalent calculated from refraction measurements taken using an autorefractometer under cycloplegia
Measured: 1 year
pourcentage of changement in optical correction
Percentage of patients who required a change in their optical correction (due to the progression of myopia) at least once during the 2-year follow-up period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2030 (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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804043
- Sponsor's protocol ID
- EPS_2026_2
- Acronym
- OPTIMA
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Sep 2026
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacité de Verres de Freination Myopique Dans Une Population de Jeunes Adultes
- ClinicalTrials.gov ID
- NCT07804043
- Acronym / sponsor ID
- OPTIMA / EPS_2026_2
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 4 Sep 2026 (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 goal of this clinical trial is to learn if myopia-control eyeglass lenses (Essilor® Stellest® 2.0) can slow down the progression of short-sightedness (myopia) in young adults, compared with standard single-vision lenses. The main questions it aims to answer are:
Does wearing Stellest® 2.0 lenses slow the increase in eye length (axial length) after 1 year, compared with standard lenses? Does wearing Stellest® 2.0 lenses reduce the change in glasses prescription and the occurrence of eye complications after 2 years, compared with standard lenses? How well do participants tolerate the Stellest® 2.0 lenses in the first weeks of wear? Researchers will compare Stellest® 2.0 myopia-control lenses to standard single-vision lenses to see if they reduce the worsening of myopia.
Participants will:
Wear either the study glasses or standard glasses every day, at least 12 hours a day, for 2 years Attend an eye exam and vision check at the start of the study, after 1 year, and after 2 years Complete three phone check-ins during the first 3 months to report on comfort and how well they tolerate their glasses
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essilor® Stellest® 2.0 myopia-slowing lenses | Experimental | Device: Essilor® Stellest® 2.0 myopia-slowing lenses |
| standard lenses | Active comparator | Device: Standard lenses |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Spherical equivalent (SE) measured under cycloplegia using an autorefractometer, within the range 4 D ≤ SE ≤ -0.75 D for each eye
- Not currently receiving, nor having received, any preventive treatment for myopic progression in the 12 months prior to inclusion (orthokeratology, soft defocus contact lenses, low-concentration atropine eye drops, corrective spectacles with peripheral defocus)
- Myopic progression of at least -0.25 D in at least one eye during the year prior to inclusion (measurements documented by autorefractometer, with or without cycloplegia, or via previous optical prescriptions) or documented progression of axial length of +0.1 mm during the year prior to inclusion
- Primary optical correction via spectacles (occasional use of contact lenses if applicable) or agreement to wear spectacles for at least 12 hours a day, every day
- Enrolled in or a beneficiary of a social security scheme
Key exclusion criteria (12 listed)
- Confirmed syndromic myopia or findings suggestive of syndromic myopia
- Obvious strabismus or significant heterophoria
- Corrected visual acuity < 8/10 in at least one eye
- A history of eye surgery (excluding eyelid surgery) in at least one eye
- Hyperopia or non-myopic astigmatism
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 |
|---|---|---|
| Essilor® Stellest® 2.0 myopia-slowing lensesEssilor® Stellest® 2.0 myopia-slowing lenses will be worn continuously throughout the day for the two-year follow-up period of the study, i.e. from the time the eyewear (lenses and frames) is dispensed until the end of the follow-up period. It is recommended that the eyewear be worn for at least 12 hours a day, every day. | Device | Essilor® Stellest® 2.0 myopia-slowing lenses |
| Standard lensesStandard lenses (Airwear single-vision lenses) will be worn continuously throughout the day during the two-year follow-up period of the study, i.e. from the time the eyewear (lenses and frames) is issued until the end of the follow-up period. It is recommended that the eyewear be worn for at least 12 hours a day, every day. | Device | standard lenses |
Primary outcome
Axial length
Time frame: 1 year
Axial length measured using the IOL Master® biometer
2 secondary outcomes
Spherical equivalent
Time frame: 1 year
pourcentage of changement in optical correction
Time frame: 2 years
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 4 Sep 2026.
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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.
Elise Philippakis contact
Vivien Vasseur contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essilor® Stellest® 2.0 myopia-slowing lenses and Standard lenses in people with Myopia, run by Fondation Ophtalmologique Adolphe de Rothschild 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 6 inclusion and 12 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 4 Sep 2026. 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 Elise Philippakis (ephilippakis@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 1 year). 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 4 Sep 2026.