Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

Launched by ESSILOR INTERNATIONAL · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of spectacle lens designed to slow down the worsening of myopia, or nearsightedness, in children. The trial will last for two years and will involve children aged between 6 and 11 years who have specific vision needs. Researchers want to see if wearing these special lenses can help prevent the eyes from growing too long, which is what happens with myopia.

To be part of this study, children must have a certain level of nearsightedness and be generally healthy. They will need to wear the glasses for more than 12 hours a day, at least six days a week, and attend regular check-ups over the two years. It's important to note that children with certain eye conditions or those who have recently used other treatments for myopia cannot participate. This trial is a chance for families to be involved in research that could lead to better ways to manage myopia in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
• • Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
• • Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
• • Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
• • Be in good general health, based on his/her and parent's/guardian's knowledge.
• • Agree to wear spectacles for \>12 hours/day and at least 6 days/week.
• • Willingness and ability to participate in investigation for 2 years and attend scheduled visits.
• Exclusion Criteria:
• • Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
• • Any binocular vision anomalies
• • Amblyopia
• • Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
• • Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
• • Participation in any clinical investigation within 30 days of the baseline visit.