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Clinical Investigation of Targeted Lens Intervention in the Management of Myopic Anisometropia in Children

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if our research spectacles will lower the difference in prescription (spectacles degree) between the eyes in children between 6 to 13 years old with anisometropic myopia. Anisometropic myopia is when the difference in myopia prescription between the two eyes are more than 1 diopter. The main question it aims to answer is: * How the eye responds to the research spectacles over time by measuring: 1. Change in axial length: the physical length of the eye from front to back. 2. Change in cycloplegic spherical equivalent refraction: an accurate measurement of the eye's prescription taken while the focusing muscles are temporarily relaxed with eye drops. Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre and an eye clinic for follow-up sessions

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 13
Healthy Volunteers: f
View:

• Voluntary

• Informed consent of parent/guardian and assent of participant

• Age equal to or greater than 6 years old and less than 13 years at the time of signing informed consent and assent

• SER equal or less than -0.50 D and equal or greater than .5.00 D with astigmatism not more than 2.50 D

• Difference in SER (anisometropia) between two eyes .1.00 D

• Best corrected visual acuity (BCVA) better than or equal to +0.20 LogMAR in each eye

• Agree to wear study spectacles for .12 hours/day and 7 days/week

• Willingness and ability to participate in investigation for 12 months and attend scheduled visits punctually

• Agree for no concurrent involvement in other myopia control treatment

Locations
Other Locations
Singapore
Essilor R&D Centre Singapore
RECRUITING
Singapore
Contact Information
Primary
Celine Carimalo
carimalc@essilor.com.sg
+65 6589 9216
Backup
Thomas Boudenne
thomas.boudenne@essilor.com
Time Frame
Start Date: 2026-08-13
Estimated Completion Date: 2027-11
Participants
Target number of participants: 20
Treatments
Experimental: More myopic eye: MCL1; Less myopic eye: MCL2
Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months.
Related Therapeutic Areas
Sponsors
Leads: Essilor International

This content was sourced from clinicaltrials.gov