Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial

Study Overview
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Brief Summary
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The aim of this clinical trial is to compare the rate of myopic progression in children wearing aspheric (MyLens) and spherical/ toric ophthalmic lenses. The proposed lens design is an aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information). Myopic progression is quantified by changes in axial length (AL) and cycloplegic refractive error (Rx) will be monitored for 6-12 months (6 months crossover) with double-masking. Peripheral refraction and ocular aberration will be evaluated.

Detailed Description
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Visual manipulation induced by progressive addition lenses (PALs) have been shown to inhibit eye growth and myopia development in children with up to 11% to 21% efficacy compared to single vision lenses. However, the treatment effect of PALs is statistically significant but clinically insufficient. The current study aims at investigating the use of spectacle lenses with a unique novel design for myopia control in children. This prospective one-year randomized clinical study will evaluate axial elongation and myopia progression in eyes using the novel lens design compared to those using the conventional single-vision design. It is a double-masked, cross-over study. One eye will be fitted with the study lens and the other eye will be fitted with the single-vision lens. Subjects will be asked to wear the spectacles for 6 months and the two lens designs will be swapped in the next 6 months after a wash-out period of 2 weeks. Both the subjects and examiners will not aware the lens design being used by the subjects in each phase.

Official Title
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Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial

Conditions
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Myopia

Intervention / Treatment
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* Device: Aspheric lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Myopia between 0.75   - 4.50 D and with-the-rule astigmatism not more than 1.50 D Difference between eyes, no more than 1.25 spherical equivalent Best corrected visual acuity (VA) is equal to or better than 0.10 in logMAR scale (Snellen VA 6/7.5 or better) Eyes straight at distance and near with best subjective correction Willing to be randomized and wear the study spectacles according to the instructions from practitioner Willing to come back for follow up in the Optometry Clinic during the study period Exclusion Criteria: Abnormal ocular and general health Prior myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period History of rigid contact lenses (including orthokeratology lenses) wearing Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome) Ocular conditions which might affect the refractive error (for example, cataract, ptosis).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspheric lens<br>An aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information) | Device: Aspheric lens<br>* By using a special asphericity, MyLens is customized for various prescriptions and vision directions based on specific measurements, intended for myopia correction and control<br>* Other names: MyLens;|
| No Intervention: Single vision spheric/toric lenses<br>Control: single vision spheric/toric lenses | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in axial length in 6-12 months | Evaluate the changes in cycloplegic axial length in the eye with aspheric lens (MyLens) compared to the other eye with single vision spheric/toric lens | Every 6 months for a period of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia control, aspheric lenses, children