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Набор скоро начнётся NCT07394556

Prospective Research on the Intervention of Myoless2.0 Effectiveness (PRIME) in Pediatric Population

— Наблюдательное Myopia Progression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: myopia control lens.
Кому может быть актуально
Состояния в реестре: Myopia Progression. Базовые параметры: 6 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Португалия, Испания, Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The Goal of the study is to evaluate the rate of myopia progression with open ring myopia control spectacle lens designs compared to a commercial peripheral plus myopia control spectacle lens (CML) in European children with myopia. This is a prospective, randomized, bilateral wear, double masked, cross-over clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML). Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group will continue wearing CML for a further 12 months; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months

Вмешательства

  • Другое myopia control lens
    Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Первичные конечные точки

  • Myopic progression in one year [Срок оценки: At baseline, 3, 6, 12, 18 and 24 months]

Критерии участия

Критерии включения

  • Be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.
  • For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
  • Be cycloplegic autorefraction spherical component -0.50 D to -6.00D, cylinder no more than -2.00D, and with a spherical equivalent greater than or equal to -6.00D.
  • Be accompanied by parents/guardians who can read and comprehend give informed consent as demonstrated by signing a record of informed consent.
  • Be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
  • Have ocular health findings considered to be "normal".
  • Be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles.
  • Be willing to wear the spectacles provided by the investigators for all waking hours.

Критерии исключения

  • A known allergy to, or a history of intolerance to cyclopentolate or topical anesthetics.
  • Had strabismus and/or amblyopia.
  • Cylinder more than -2.00D
  • Anisometropia greater than 1.50D spherical equivalent
  • Had previous eye surgery (including strabismus surgery).
  • Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes.
  • Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids.
  • Current orthoptic treatment or vision training.
  • Any anatomical, skin or other condition that would impact on the wearing of spectacles.
  • Use of or need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
  • Currently enrolled in another clinical trial.
  • No previous myopia management intervention or treatment.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Португалия · 1 центр
  • Universidade Do Minho — Braga
Испания · 1 центр
  • Hospital Universitario Clínico San Carlos — Madrid
Великобритания · 1 центр
  • Ulster University — Coleraine

Публикации

  • Martinez-Perez C, Sanchez-Tena MA, Cleva JM, Villa-Collar C, Alvarez M, Chamorro E, Alvarez-Peregrina C. Efficacy of Asymmetric Myopic Peripheral Defocus Lenses in Spanish Children: 24-Month Randomized Clinical Trial Results. Children (Basel). 2025 Feb 6;12(2):191. doi: 10.3390/children12020191. PMID 40003293
  • Sanchez-Tena MA, Cleva JM, Villa-Collar C, Alvarez M, Ruiz-Pomeda A, Martinez-Perez C, Andreu-Vazquez C, Chamorro E, Alvarez-Peregrina C. Effectiveness of a Spectacle Lens with a Specific Asymmetric Myopic Peripheral Defocus: 12-Month Results in a Spanish Population. Children (Basel). 2024 Feb 1;11(2):177. doi: 10.3390/children11020177. PMID 38397289

Идентификаторы

NCT: NCT07394556 · IOT-PRIME-2026-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗