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NOT YET RECRUITING
NCT07804043
NA

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

Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

View on ClinicalTrials.gov

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

Official title: Efficacité de Verres de Freination Myopique Dans Une Population de Jeunes Adultes

Key Details

Gender

All

Age Range

16 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2026-11-01

Completion Date

2030-12-01

Last Updated

2026-09-04

Healthy Volunteers

No

Conditions

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.

Locations (1)

Hopital Fondation A de Rothschild

Paris, France