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This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.
As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.
This double masked parallel group study will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test myopia control lenses | Experimental | A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months. |
|
| Single vision lenses | Other | A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test myopia control lenses | Device | A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial Length | Change in ocular axial length (mm) measured using Lenstar Optical Biometer. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Spherical Equivalent Refraction | Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction. | 6 months and 12 months |
| Axial Length | Change in ocular axial length (mm) measured using Lenstar Optical Biometer. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Tan | Essilor R&D Centre Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essilor R&D Centre Singapore | Singapore | 339346 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33811039 | Background | Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2. |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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This is a randomized, controlled, 2-armed, double-masked, monocenter, clinical trial, which consists of 6 visits across 1 year. The test myopia control lens will be compared with a single vision control lens in evaluating study objectives. After obtaining informed consent and assent, a comprehensive eye examination for screening will be done among approximately 80 myopic children between the age of 8-13 years old for eligibility. After randomization, the subjects will be back for dispensing of study spectacles and for baseline visit, where assessment of study spectacles, biometry, and instructions to use study spectacles were done. A follow up visit will be conducted in 3, 6 and 12 months time, in which the latter visit will also be the end of visit. All of which are non-contact and non-invasive to the eyes.
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Subjects (and their parents/guardians) will be masked to the lens assignment. Sibling of subjects must be excluded due to the noticeable differences between the test and control spectacle lenses Only the statistician will be unmasked when comparing the two lenses. The investigator who is responsible for randomization and allocation will also be unmasked. However, the primary outcome variables (spherical equivalent refraction & axial length) will be taken by masked investigators. To facilitate this, the subject will be led into the room(s) containing a biometer without their study spectacles by the unmasked investigator.
| Single vision lenses | Device | A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months. |
|
| 6 months |
| Carry-over Effect | Change in ocular axial length (mm) measured using Lenstar Optical Biometer after switching to STELLESTâ„¢ lenses | 18 months and 24 months |