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

August 31, 2026 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75019
        • Hopital Fondation A de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Essilor® Stellest® 2.0 myopia-slowing lenses
Device: Essilor® 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.
Active Comparator: standard lenses
Device: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length
Time Frame: 1 year
Axial length measured using the IOL Master® biometer
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spherical equivalent
Time Frame: 1 year
Spherical equivalent calculated from refraction measurements taken using an autorefractometer under cycloplegia
1 year
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPS_2026_2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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