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This is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial NCT05331378. A total of 40 children will be recruited.
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 (Bao et al. 2022). A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.
This open clinical trial 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 (40 subjects) at the time of commencing treatment. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuities will also be compared between test lenses and control lenses of the historical control group to determine the quality of vision using test lenses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test myopia control lenses (CSL) | Experimental | A pair of myopia control spectacle lenses (test lenses) will be given to subjects to wear for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test myopia control lenses (CSL) | Device | A pair of myopia control spectacle lenses (test lenses) will be given to subjects 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 |
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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 |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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This is a mono-centre, prospective, one-arm, unmasked clinical trial, which consists of 6 visits, across 12 months. The objective of this clinical trial is to compare the test myopia control spectacle lens to the single vision control spectacle lens from the previous clinical trial, otherwise termed as historical control group.
After obtaining informed consent and assent, a comprehensive eye examination will be conducted during the screening visit on all 40 myopic children between the age of 8 to 13 years old. Eligible children will return in a separate visit (baseline visit) to collect the study spectacles and the assessment of study spectacles, biometry and instructions to use study spectacles are established in the same visit. A follow up visit will be conducted in 3, 6 and 12 months time, where 12 months is the end of study. All of the eye examinations and assessments are non-contact and non-invasive to the eyes.
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