Wearability of and Myopia Progression With ZEISS MyoCare Spectacle Lenses

Официальное название

A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Wearability and Myopia Progression of ZEISS MyoCare Spectacle Lenses Versus Two ZEISS Single Vision Spectacle Lenses in Children With Myopia

Обзор

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.

Вмешательства

• Устройство ZEISS MyoCare spectacle lenses
  Spectacle lenses with conventional power profile including myopia control design.
• Устройство ZEISS SV RX SPH 1.5
  Commercially available single vision
• Устройство ZEISS Clearview
  Commercially available single vision

Первичные конечные точки

• Wearability [Срок оценки: Day 1 At dispensing visit, 3 months and 6 months visits]
• Wearability [Срок оценки: Day 1 At dispensing visit, 1-week and 2-week visits, and 3 months and 6 months visits]
• Wearability [Срок оценки: At 1-week, 2-week, 3 months and 6 months visits]

Вторичные конечные точки (2)

• Myopia progression [Срок оценки: At baseline and 6 months visits]
• Myopia progression [Срок оценки: At baseline, 3 months, and 6 months visits]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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, Sjögrens syndrome and systemic lupus erythematosus.
• Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial. NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
• History of eye trauma or eye surgery
• Amblyopia
• Anisometropia of not more than 1.50D
• Strabismus
• History of use of myopia control interventions such as Orthokeratology or atropine 3 months prior to commencement of this trial.
• Known allergy or intolerance to ingredients to cycloplegic eye-drops.
• Currently enrolled in another clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Hanoi Eye Hospital 2 — Hanoi

Идентификаторы

NCT: NCT07021560 · 28/CV-MHN2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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