NCT05809674已完成不适用
Polarization Sensitive Optical Coherence Tomography - Phase II: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Primary Aim
研究概览
简要总结
The purpose of the study is to use the polarization sensitive optical coherence tomography (PS-OCT) developed by Singapore Eye Research Institute, to evaluate the potential OCT scleral biomarkers capable of predicting risk of myopia progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Adult Cohort)
- •Aged 21 and above
- •Ability to provide informed consent
- •42 normal controls: No diabetes and free from clinically relevant eye disease that interferes with the aim of the study i.e. glaucoma, diabetic retinopathy, age-related macular degeneration, uveitis, or vascular occlusive diseases
- •76 subjects with pathological myopia (up to -12 dioptres) or staphyloma
- •(Children Cohort)
- •Aged 10 to 18
- •23 subjects with low to moderate myopia (-0.75 to -6 dioptres)
- •23 subjects with high myopia (more than -6 dioptres)
- •Ability of legal representative and subject to provide informed consent
排除标准
- •(Adult Cohort)
- •Unable to give consent
- •Subjects with visual acuity worse than 6/12
- •Diagnosis of clinically relevant eye disease that interferes with the aim of the study (e.g. diabetic retinopathy, hereditary macular disease, glaucoma, uveitis, or vascular occlusive diseases) or conditions that may potentially result in poor quality imaging scans (severe cataract, corneal haze/opacity)
结局指标
主要结局
Primary Aim
时间窗: 1.5 years
High reproducibility in myopia cases as shown in PS-OCT derived sclera anisotropy patterns
次要结局
- Secondary Aim(1.5 years)
研究者
研究点 (1)
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