Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

Launched by ESSILOR INTERNATIONAL · Apr 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a special type of lens designed to slow down the worsening of myopia, which is a common vision problem where distant objects appear blurry. The trial will compare these test lenses to regular single vision glasses to see if they can help prevent myopia from getting worse over the course of one year. The study will involve 80 children, aged between 8 and 13 years, who will be randomly assigned to wear either the new test lenses or the control lenses.

To be eligible for the trial, children must have a specific range of vision issues and be in good overall health. They should also be able to understand and agree to participate in the study with the help of a parent or guardian. Participants will have regular check-ups to monitor their vision and overall health. It’s important to note that the study is currently active but not recruiting new participants at this time. If you think this might be of interest to you or your child, it’s a good idea to discuss it further with your eye care professional.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form.
• • Equal to or greater than 8 years and not older than 13 years at time of informed consent and assent.
• • Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
• • Astigmatism, if present, of not more than 1.50 D.
• • Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
• • Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
• • Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
• • History of myopia control intervention
• • Absence of strabismus by cover test at near or distance wearing correction.
• • Absence of amblyopia
• • Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
• • Exclusion Criteria
• • Vulnerability of subject
• • Participation in any clinical study within 30 days of the Baseline visit.
• • Sibling of existing participant of this study