Inhibition of Myopia Progression With Optical Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity test
研究概览
简要总结
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:
- How does myopia progression change with age while wearing myopia progression control glasses?
- 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?
- 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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •• 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
研究组 & 干预措施
Myopic cohort
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 while awake
- Participation in follow-up examinations every 6 months
Exclusion criteria:
- 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
干预措施: Wearing myopia-control D.I.M.S. glasses while awake (Device)
Myopic cohort
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 while awake
- Participation in follow-up examinations every 6 months
Exclusion criteria:
- 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
干预措施: DIMS (Defocus Incorporated Multiple Segments) lenses (Device)
结局指标
主要结局
Best corrected visual acuity test
时间窗: up to 24 week
Zero is equivalent to no vision and 1.0 indicates the best visual acuity in decimal scale. Distance and near visual acuity is measured under standard conditions
Bulbar axial length measurement
时间窗: up to 24 week
It is defined as the distance from the anterior surface of the cornea to the retinal pigment epithelium, measured in millimeters using optical device. An increase in axial length is characteristic of the elongation of the eye.
次要结局
- Stereopsis(up to 24 week)
研究者
Barcsay-Veres Amarilla
Principal Investigatorr
Semmelweis University