Inhibition of Myopia Progression With Optical Devices

Обзор

This observational study aims to determine whether optical devices designed to slow myopia progression and/or environmental factors can prevent myopia progression in the pediatric and adolescent myopic population. The study aims to answer the following questions: 1. How does myopia progression change with age while wearing myopia progression control glasses? 2. How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account? 3. How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? This will be a self-controlled observational study. Participants who are myopic after cycloplegic refraction will be prescribed DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children. Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time. Patients will visit the clinic once every six months for checkups and the following tests: * Best corrected visual acuity test * Stereopsis * Automatic refractometry * Bulbar axial length measurement In a follow-up study, researchers will compare myopia progression with environmental and baseline factors to learn about the long-term effects of DIMS lenses on myopia progression.

Подробное описание

As an observational study we aim to examine the effects of D.I.M.S. lens's daily wear on myopia progression in relation to the environmental factors.

Our pediatric and adolescent myopic population is selected as follows:

Inclusion Criteria:

* Participants must be between 6 and 15 years of age at the start of myopia progression treatment * Caucasian ethnicity * Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph * Wearing myopia-control glasses during waking hours * Willing to Participate in follow-up examinations up to 24 weeks

Exclusion criteria:

* pathological myopia (e.g., myopia onset before age 6, Stickler syndrome) * preterm infants born before 32 weeks of gestation * previous eye-opening surgery (e.g., lens extraction) * Traumatic eye injury * Known connective tissue disorder (e.g., Marfan syndrome) * Irregular or improper use of progressive-lens glasses * Failure to attend the follow-up examinations scheduled

In the self-controlled observational study the myopic participants are wearing during day time DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children. DIMS glasses not only correct the refractive errror but also provide a circular defocus zone to avoid periferial retinal defocus.

Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time, subjective symptoms.

Patients will visit the clinic once every six months for checkups and the following tests:

* Best corrected visual acuity test * Stereopsis * Automatic refractometry * Bulbar axial length measurement These measurements and tests are part of the regular ophthalmological follow-up examinations.

The study aims to answer the following questions:

1. How does myopia progression change with age while wearing myopia progression control glasses? 2. How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account? 3. How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? Statistical analysis plan includes non-parametric t-test, one way and two way ANOVA tests.

Вмешательства

• Устройство Wearing myopia-control D.I.M.S. glasses while awake
  DIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake
• Устройство DIMS (Defocus Incorporated Multiple Segments) lenses
  D.I.M.S. lenses are worn like normal glasses to correct myopia and, beyond that, their special design is intended to slow myopia progression via defocus lenslets. There is targeted myopic defocus produced by the mid-peripheral lenslets with positive power to inhibit eye length growth.

Первичные конечные точки

• Best corrected visual acuity test [Срок оценки: up to 24 week]
• Bulbar axial length measurement [Срок оценки: up to 24 week]

Вторичные конечные точки (1)

• Stereopsis [Срок оценки: up to 24 week]

Критерии участия

Критерии включения

• • Participants must be between 6 and 15 years of age at the start of myopia progression treatment

• Caucasian ethnicity
• Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph
• Wearing myopia-control glasses while awake
• Participation in follow-up examinations every 6 months

Критерии исключения

• • Pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)

• Premature birth before the 32nd week of gestation
• Previous eye-opening surgery (e.g., lens removal)
• Traumatic eye injury
• Known connective tissue disorder (e.g., Marfan syndrome)
• Irregular or improper use of progressive-lens glasses
• Failure to attend the follow-up examinations scheduled every 6 months

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Венгрия · 1 центр

• Semmelweis University Ophthalmology Department — Budapest

Идентификаторы

NCT: NCT07698977 · SE-RKEB 222/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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