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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:
Change in axial length
Change in choroidal thickness
Participants will:
Wear the study spectacles
Visit Essilor R&D Centre for follow-up sessions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OD: MCL 1; OS: MCL 2 | Experimental | 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. |
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| OD: MCL 2; OS: MCL 1 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCL 1 | Device | Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Axial Length | Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Choroidal Thickness | Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense. |
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Inclusion Criteria:
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):
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:
No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
Exclusion Criteria:
History or presence of:
Currently or previously on any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
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| Name | Affiliation | Role |
|---|---|---|
| Aparna Gopalakrishnan | Essilor R&D Centre Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essilor R&D Centre Singapore | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40038807 | Background | Li X, Huang Y, Liu C, Chang X, Cui Z, Yang Q, Drobe B, Bullimore MA, Chen H, Bao J. Myopia control efficacy of spectacle lenses with highly aspherical lenslets: results of a 5-year follow-up study. Eye Vis (Lond). 2025 Mar 5;12(1):10. doi: 10.1186/s40662-025-00427-3. | |
| 31360614 | Background | Lau JK, Wan K, Cheung SW, Vincent SJ, Cho P. Weekly Changes in Axial Length and Choroidal Thickness in Children During and Following Orthokeratology Treatment With Different Compression Factors. Transl Vis Sci Technol. 2019 Jul 23;8(4):9. doi: 10.1167/tvst.8.4.9. eCollection 2019 Jul. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| MCL 2 | Device | Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months. |
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