ClinicalTrials.gg
Not yet recruitingNCT07804043OPTIMAUpdated Sep 4, 2026

Efficacy of Myopia-control Lenses in a Population of Young Adults : the OPTIMA Study

An interventional study of Essilor® Stellest® 2.0 myopia-slowing lenses and Standard lenses in Myopia, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Not yet recruiting at 1 site in France. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
16 Years to 25 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Myopia

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03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 134 is above the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 to participate in the study by the adult patient or by a person with parental authority for minor patients

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (estimated)

Study arms

  • Experimental
    Essilor® Stellest® 2.0 myopia-slowing lenses

    Device: Essilor® Stellest® 2.0 myopia-slowing lenses

  • Active comparator
    standard lenses

    Device: Standard lenses

Interventions

  • DeviceEssilor® Stellest® 2.0 myopia-slowing lenses

    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.

  • DeviceStandard lenses

    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.

06

What researchers measure

Primary outcomes

  1. Axial length

    Axial length measured using the IOL Master® biometer

    Time frame: 1 year

Secondary outcomes

  1. Spherical equivalent

    Spherical equivalent calculated from refraction measurements taken using an autorefractometer under cycloplegia

    Time frame: 1 year

  2. 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

    Time frame: 2 years

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.

Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 25 months is close to that.

Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 4, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Dec 1, 2028
CompletionEst.
Dec 1, 2030
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07804043
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2030 (estimated)
Last update
Sep 4, 2026

Study contacts

Elise Philippakis
Contact
ephilippakis@for.paris
Vivien Vasseur
Contact
vvasseur@for.paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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