Retinal Oxygen Metabolism in Children With Myopia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Retinal oxygen extraction
研究概览
简要总结
The aim of the present study is to gain more information about retinal functional parameters in myopic children in Europe. For this purpose, a prospective case-control study in children aged between 8 and 13 years, as this is the usual age of myopia onset, will be conducted. Forty myopic children will be age- and sex-matched to non-myopic controls. Retinal oxygen extraction will be used as the main outcome parameter, as data from animal and human studies point towards an involvement of hypoxia in the disease process. In addition, other parameters probably linked to myopia will be investigated, such as retinal and choroidal blood flow as well as choroidal and retinal vessel density and anatomical structures such as choroidal and central retinal thickness. Also, questionnaires about lifestyle factors will be completed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for children with myopia:
- •Children aged between 8 and 13 years (inclusive)
- •Signed informed consent of child and legal guardian
- •Normal ophthalmic findings except myopia
- •Cycloplegic spherical equivalent (SE) refraction ≤ -1.0dpt in both eyes
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Inclusion criteria for healthy age- and sex-matched controls:
- •Children aged between 8 and 13 years (inclusive)
- •Signed informed consent of child and legal guardian
- •Normal ophthalmic findings
- •Cycloplegic spherical equivalent (SE) refraction between +0.5dpt and -0.5dpt
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Intake of stimulating beverages containing xanthine derivatives (tea, coffee, cola-like drinks) 12 hours before the study day
- •Previous eye abnormalities such as cataract, keratopathy, strabismus, amblyopia, ocular inflammation, trauma, or surgery
- •History of any disease or syndrome associated with severe myopia such as Marfan syndrome, Stickler syndrome, or retinopathy of prematurity
- •Non-axial cause of myopia
- •BCVA less than 20/25
- •Intraocular pressure ≥ 21mmHg
- •Astigmatism ≤ -1.0dpt
- •Anisometropia ≥ 2dpt
- •Not able to read letters for visual acuity testing
研究组 & 干预措施
children with myopia
children with myopia
healthy age- and sex-matched controls
healthy age- and sex-matched controls
结局指标
主要结局
Retinal oxygen extraction
时间窗: Study Day 1
Retinal oxygen extraction measured with LSFG and RVA
次要结局
- Retinal and choroidal vessel density(Study Day 1)
- Lifestyle factors(Study Day 1)
- Axial eye length(Study Day 1)
- Intraocular pressure(Study Day 1)
- Refraction in cycloplegia(Study Day 1)
- Choroidal and retinal blood flow(Study Day 1)
- Choroidal and central retinal thickness(Study Day 1)
研究者
Doreen Schmidl
Assoc. Prof. Priv. Doz. Dr., PhD
Medical University of Vienna