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

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.

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

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)