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

NCT07804043 — Not applicable, Not yet recruiting, 134 participants, Fondation Ophtalmologique Adolphe de Rothschild

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Efficacité de Verres de Freination Myopique Dans Une Population de Jeunes Adultes

Registry	NCT07804043, acronym OPTIMA
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	134 (Estimated)
Sponsor	Fondation Ophtalmologique Adolphe de Rothschild (Network)
Conditions	Myopia
Interventions	Essilor® Stellest® 2.0 myopia-slowing lenses, Standard lenses (Device)
Dates	start 2026-11-01 (estimated), primary completion 2028-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2026-09-04, last updated 2026-09-04
Locations	1 site in France

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Essilor® Stellest® 2.0 myopia-slowing lenses	Experimental	Device: Essilor® Stellest® 2.0 myopia-slowing lenses
standard lenses	Active comparator	Device: Standard lenses

Essilor® Stellest® 2.0 myopia-slowing lenses (Device): 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 lenses (Device): 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.

+Outcome measures

Primary outcomes

Axial length [1 year]: Axial length measured using the IOL Master® biometer

Secondary outcomes

Spherical equivalent [1 year]: Spherical equivalent calculated from refraction measurements taken using an autorefractometer under cycloplegia
pourcentage of changement in optical correction [2 years]: 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

+Eligibility

Sex: All, ages: 16 Years to 25 Years

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

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)

+Locations (1)

Facility	City	Country	Status
Hopital Fondation A de Rothschild	Paris	France