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Evaluation of the Effectiveness of a New Generation of Myopia Control Lens, Producing a Higher Myopic Control Signal Than That Produced by a Previous Generation Lens, on the Progression of Myopia in Children Aged 6 to 14 Years

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

The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye? Researchers will compare MCL1 to a former generation of myopia control lens (i.e. MCL2) but with better vision quality. Participants will: * Wear MCL1 on right eye and MCL2 on left eye for 6 months and MCL2 on rigth eye and MCL1 on left eye for the next 6 months; * Visit the hospital at 6 and 12 months for tests; * Answer weekly questionnaires on compliance wearing glasses, quality of vision and out-of-school activities.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 14
Healthy Volunteers: f
View:

• Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia)

• Astigmatism ≤ 2.00 D for each eye

• Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D

• Corrected maximum distance visual acuity in each eye≥ 8/10 (equivalent to +0.1 LogMAR)

• Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant

Locations
Other Locations
France
Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild
RECRUITING
Paris
Contact Information
Primary
Thibaut Chapron, MD
tchapron@for.paris
00331 48 03 65 56
Time Frame
Start Date: 2026-03-18
Estimated Completion Date: 2028-05
Participants
Target number of participants: 76
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