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This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. A total of 25 children will be recruited.
As myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. In a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children.
This clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. Without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. The study population includes 25 children subjects in Singapore, aged 6 to 8 years during the commencement of the treatment. The axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test myopia control lenses (BSL) | Experimental | Test spectacle lens will be given to the subjects over 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test myopia control lenses (BSL) | Device | Test spectacle lenses will be provided to the subjects throughout the 1 year clinical trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Evaluate the change in axial length (mm) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Evaluate change in axial length (mm) | 6 months |
| Spherical Equivalent Refraction | Evaluate change in Spherical Equivalent Refraction (Diopters) through manifest subjective refraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essilor R&D Centre | Singapore | 339338 | 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-center, single-arm, unmasked study consisting of 6 visits over 1 year. This study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lenses over a 1-year period.
After obtaining informed consent and assent, a comprehensive eye examination will be conducted during the screening visit on all participants. Eligible participants, total of 25, between ages 6 to 8 years old will be enrolled into the study. On a separate visit, the enrolled subjects will return for a baseline visit to collect the study spectacles. During the baseline visit, instructions on study spectacles usage, assessment with study spectacles and ocular biometry will be conducted. Follow-up visits will be conducted at 3, 6 and 12 months' time, where 12 months is the end of study.
All eye examinations and assessments are non-contact and non-invasive to the eyes.
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| 6 months, 12 months |