Myopia Clinical Trial
Official title:
A Double-masked, Randomized, 2-armed Comparative Study of a Myopia Control Lens (Test Lens) Versus Single Vision Lens (Control Lens).
Verified date | September 2023 |
Source | Essilor International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 13 Years |
Eligibility | Inclusion Criteria: - Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent & assent form. - Equal to or greater than 8 years and not older than 13 years at time of informed consent and assent. - Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye. - Astigmatism, if present, of not more than 1.50 D. - Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D. - Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (= 20/25 as Snellen) - Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status. - History of myopia control intervention - Absence of strabismus by cover test at near or distance wearing correction. - Absence of amblyopia - Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. Exclusion Criteria - Vulnerability of subject - Participation in any clinical study within 30 days of the Baseline visit. - Sibling of existing participant of this study |
Country | Name | City | State |
---|---|---|---|
Singapore | Essilor R&D Centre Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
Essilor International |
Singapore,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Axial Length | Change in ocular axial length (mm) measured using Lenstar Optical Biometer. | 12 months | |
Secondary | Spherical Equivalent Refraction | Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction. | 6 months and 12 months | |
Secondary | Axial Length | Change in ocular axial length (mm) measured using Lenstar Optical Biometer. | 6 months | |
Secondary | Carry-over Effect | Change in ocular axial length (mm) measured using Lenstar Optical Biometer after switching to STELLESTâ„¢ lenses | 18 months and 24 months |
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