Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression - Open Clinical Trial

Conditions
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Myopia

Intervention / Treatment
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* Device: Test myopia control lenses (BSL)


Participation Criteria
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Eligibility Criteria
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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. 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 History of myopia control intervention Participation in any clinical study within 30 days of the Baseline visit.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a mono-centre, prospective, one-arm, unmasked clinical trial, which consists of 9 visits, across 24 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, 12, 18 and 24 months time, where 24 months is the end of study. All of the eye examinations and assessments are non-contact and non-invasive to the eyes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test myopia control lenses (BSL)<br>Myopia control spectacle lenses (test lenses) will be given to subjects throughout the 24 months trial. | Device: Test myopia control lenses (BSL)<br>* Myopia control spectacle lenses (test lenses) will be given to subjects throughout the 24 months trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length | Change in ocular axial length (mm) | 12 months and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length | Change in ocular axial length (mm) | 6 months and 18 months | 
| Spherical Equivalent Refraction | Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction. | 6 months, 12 months, 18 months and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractive errors, Eye diseases