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This is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression.
The clinical trial aims to assess the safety and efficacy of a test lens, designed to modify the amount of myopic control signal on the retina without compromising vision. The primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCL1 | Active Comparator | The MCL1 is a myopia control lens that will be worn in one eye for 6 months. |
|
| MCL2 | Experimental | The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myopia Control Lens-1 (MCL1) | Device | The MCL1, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on one eye for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Axial Length | To evaluate the effectiveness of the MCL2 in slowing myopia progression with respect to the change in Axial Length (AL) from baseline compared to MCL1 at 12-month. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spherical Equivalent Refraction | To evaluate the effectiveness of the MCL2 lens in slowing myopia progression with respect to the change in Spherical Equivalent Refraction (SER) from baseline compared to MCL1 at 12-month. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wee Sing Ong | 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 |
|---|---|---|---|
| 26875007 | Background | Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11. | |
| 35357402 | Background |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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This is a one-year, mono-centre, randomized, double-masked, monocular cross-over Clinical Trial with the objective to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopic progression. The subject starts by wearing Myopia Control Lens 1 (MCL1) in one eye, and Myopia Control Lens 2 (MCL2) in another eye. After 6 months, a new pair of study spectacles will be dispensed with MCL1 and MCL2 crossed over. At the end of the 1-year period, each eye would have worn both MCL1 and MCL2 for 6 months each. There will be a total of 7 study visits with follow up periods at 3 months, 6 months and 12 months
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As this is a double-masked, randomized controlled trial, both the investigators and subjects will be masked.
| Myopia Control Lens-2 (MCL2) | Device | The MCL2, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on the contralateral eye for 6 months. |
|
| Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401. |
| 23290590 | Background | Smith EL 3rd. Optical treatment strategies to slow myopia progression: effects of the visual extent of the optical treatment zone. Exp Eye Res. 2013 Sep;114:77-88. doi: 10.1016/j.exer.2012.11.019. Epub 2013 Jan 3. |