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NCT Number: NCT07804043

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

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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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Fondation A de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Axial length

    Time frame: 1 year

    Axial length measured using the IOL Master® biometer

Secondary outcomes

  1. Spherical equivalent

    Time frame: 1 year

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

  2. pourcentage of changement in optical correction

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Philippakis

CONTACT

[email protected]

Vivien Vasseur

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: OPTIMA

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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