A Monocentre, Randomized, Contralateral Trial to Study the Effect of Temporal Changes in Ocular Biometry of Two Myopia Control Lenses

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

The goal of this clinical trial is to investigate the short-term changes in the eye structure while wearing two types of lenslet-based myopia control lenses over a period of 6 months in children aged 6 to 13 years with myopia. The main question it aims to answer is: * How the eye responds, at each timepoint, to the two myopia control lenses by evaluating: 1. Change in axial length 2. Change in choroidal thickness Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre for follow-up sessions

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

• Volunteer participant

• Informed consent of parent or guardian and assent of participant

• Age: Equal to or greater than 6 years but not older than 13 years at the time of informed consent and assent.

• Refractive error (manifest refraction):

‣ Equal or less than -0.50 D or equal or greater than -4.75D.

⁃ Astigmatism should be less than or equal to 2.00D.

• Anisometropia should be less than or equal to 1.00D

• Best corrected visual acuity: Better than 0.2 logMAR in each eye

• Willingness and ability to:

‣ participate in trial for at least 6 months.

⁃ attend scheduled visits.

⁃ not to be involved in other myopia control treatments concurrently.

• No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)

Locations
Other Locations
Singapore
Essilor R&D Centre Singapore
RECRUITING
Singapore
Contact Information
Primary
Celine Carimalo
carimalc@essilor.com.sg
+65 67134600
Backup
Thomas Boudenne
thomas.boudenne@essilor.com
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2026-09
Participants
Target number of participants: 20
Treatments
Experimental: OD: MCL 1; OS: MCL 2
Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months.
Experimental: OD: MCL 2; OS: MCL 1
Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months.
Related Therapeutic Areas
Sponsors
Leads: Essilor International

This content was sourced from clinicaltrials.gov