Myopia
Conditions
Brief 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
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.
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 1 year | Axial length measured using the IOL Master® biometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
CONTACTElise Philippakis
CONTACTVivien Vasseur
Outcome results
None listed