Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myopic Children

Официальное название

Evaluation of Visual Comfort, Adaptation, and Satisfaction With a Myopia Control Lens in Myopic Children

Обзор

The goal of this clinical trial is to demonstrate that the visual comfort, adaptation, and overall satisfaction associated with the use of the test spectacle lenses are not inferior to those of the control spectacle lenses in myopic children age ≥ 6 years and \< 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is: Do children adapt to the test spectacle lenses within the first 1-2 weeks of wear without significant symptoms or complaints? Is the level of visual comfort and overall satisfaction with test spectacle lenses comparable to that of control spectacle lenses during the early adaptation period? Researchers will compare questionnaire responses between participants wearing test lenses and those wearing control lenses to assess whether the test lenses are non-inferior in terms of visual comfort, adaptation, and user satisfaction. Participants will: * Wear the study spectacles for 2 weeks * Respond to questionnaires 4 days after dispensing and at 2 weeks * Visit Essilor R\&D Centre for screening, dispensing and follow up sessions

Вмешательства

• Устройство HADAL Spectacle Lenses
  Dispense to Test group for 2 weeks
• Устройство Stellest® Spectacle Lenses
  Dispense to Control group for 2 weeks

Первичные конечные точки

• Successful Adaptation Rate Within 1 Week After Dispensing [Срок оценки: Within 1 week post dispensing]

Вторичные конечные точки (5)

• Successful Adaptation Rates at Early and Later Timepoints [Срок оценки: 4 days and 2 weeks post-dispensing]
• Average daily and weekly wearing time [Срок оценки: Assessed at Day 4 and Week 2 post-dispensing]
• Activity-specific visual comfort [Срок оценки: 4 days and 2 weeks post-dispensing]
• Overall satisfaction [Срок оценки: 4 days and 2 weeks post-dispensing]
• High-contrast visual acuity (distance and near) [Срок оценки: At dispensing (baseline) and 2 weeks post-dispensing]

Критерии участия

Критерии включения

• Volunteer participant who is willing and able to comply with all scheduled study visits.
• Informed consent of parent/guardian and assent of participant.
• Age ≥ 6 years and < 11 years at the time of signing informed consent and assent.
• Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes.
• Difference in SER (anisometropia) between two eyes should not exceed 1.50 D.
• Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR in each eye.
• Be in good general health, based on the participant and the parent's/guardian's knowledge.

Критерии исключения

• History of Atropine, Orthokeratology, Contact Lens or Red Light treatment.
• Strabismus by cover test at near or distance wearing correction.
• History and presence of amblyopia.
• Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
• Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
• History of ocular injury or surgery.
• Participation in any clinical study within 30 days of the Baseline visit.
• Sibling of existing participant of this study
• Study participants deemed inappropriate for the study by the investigator.
• The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07683481 · WS10506 · PIEC/2026/015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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