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Recruiting NCT07021560

Wearability of and Myopia Progression With ZEISS MyoCare Spectacle Lenses

Trial Parameters

Condition Myopia
Sponsor ZEISS Vision Care
Study Type INTERVENTIONAL
Phase N/A
Enrollment 90
Sex ALL
Min Age 7 Years
Max Age 13 Years
Start Date 2025-05-27
Completion 2026-01
Interventions
ZEISS MyoCare spectacle lensesZEISS SV RX SPH 1.5ZEISS Clearview

Brief Summary

This is a clinical trial evaluating the wearability and effectiveness of three types of ZEISS spectacle lenses in controlling myopia progression. This study compares ZEISS MyoCare spectacle lenses with two types of single-vision spectacle lenses over a 6-month period. This trial aims to evaluate how well these lenses are worn and their impact on myopia progression, including changes in axial length and refractive error. Participants will be randomly assigned to wear one of three types of ZEISS spectacle lenses. The study will require five visits to the eye clinic over a 6-month period and two virtual follow-up visits.

Eligibility Criteria

Inclusion Criteria: * be accompanied by a parent or guardian who is able to read and comprehend Vietnamese/English and sign a record of informed consent/assent; * at baseline, be within the age range of 7 to 13 years old inclusive; * be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre (D); * astigmatism ≤1.50D; * anisometropia of not more than 1.50D; * be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator; * have ocular findings deemed to be normal; * vision correctable to at least 0.8 or better in each eye with spectacles. Exclusion Criteria: * Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; * Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögren

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