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

NCT07804043 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-09-04

No results posted yet for this study

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

Conditions

  • Myopia

Interventions

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.

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.

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2028-12-01
Completion
2030-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804043 on ClinicalTrials.gov