Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

Обзор

This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy. This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.

Вмешательства

• Устройство Single vision, impact-resistant spectacle lenses; Test Arm
  Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
• Устройство Single vision, impact-resistant spectacle lenses; Control Arm
  Single vision, impact-resistant spectacle lenses

Первичные конечные точки

• Spherical equivalent refraction [Срок оценки: 12 months]

Вторичные конечные точки (1)

• Axial length [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
• Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
• Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
• Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
• The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;
• Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
• Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;
• Willingness to participate in the trial for 24 months without contact lens wear;
• The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Критерии исключения

• Subject has previously or currently wears contact lenses (greater than 1-month usage);
• Current or prior use of bifocals, progressive addition spectacle lenses
• Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
• Amblyopia in either eye;
• Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
• Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\];
• Known allergy to proparacaine, tetracaine, or tropicamide;
• Participation in any investigational clinical study within 30 days of the Baseline visit;
• Subject's sibling or other household member is already enrolled in this 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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 14 центров

• Elsa Pao, OD — Oakland
• Scripps Poway Eyecare — San Diego
• Pacific Rims Optometry — San Francisco
• Paje Optometric — Santa Ana
• Omega Vision Center — Longwood
• Marietta Eye Clinic — Marietta
• Ilinois College of Optometry — Chicago
• Kannarr Eye Care — Pittsburg
• … и ещё 6 центров

Идентификаторы

NCT: NCT06034327 · CPRO-2304-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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