NCT06846151尚未招募不适用
Clinical Investigation of Optos OCT in Patients with Retinal Pathologies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Optos, PLC
- 入组人数
- 120
- 主要终点
- OCT physical response data
研究概览
简要总结
Retinal investigation using OCT with control and diseased eyes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants 18 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed.
- •Participants who understand the study and patient information sheet and can follow the instructions.
- •Participants who agree to participate in the study.
- •Control group where no retinal abnormalities were detected as part of the standard basic ophthalmic examination.
- •Participants with retinal disease in at least one eye including: Early dry age-related macular degeneration, late stage dry age-related macular degeneration specifically geographic atrophy, Wet age-related macular degeneration, Retinitis pigmentosa, Diabetic retinopathy and other macular atrophic diseases
排除标准
- •Inability to understand written and verbal English sufficiently to comprehend the study and provide informed consent
- •Ophthalmic disease other than condition under investigation.
- •Participants unable to tolerate ophthalmic imaging.
- •Cataract (unless deemed mild in the opinion of the investigator)
- •Participants with significant ocular media not sufficiently clear to obtain acceptable OCT images.
- •Diabetes (unless part of the diabetic eye disease group)
- •Binocular visual acuity worse than 6/18
- •Strabismus (squint)
- •Age related macular degeneration groups: polypoidal choroidal vasculopathy
- •Participants with photo sensitivity epilepsy, experience of seizures, or sensitivity to flickering light (based on self-report)
结局指标
主要结局
OCT physical response data
时间窗: 6 months from recruitment start
Response data per participant will be collected and analyzed
次要结局
未报告次要终点
研究者
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