A Multicenter, Cross-sectional Study to Describe the Conjunctiva and Tenon's Capsule Status of Healthy Subjects and nAMD/DME Patients Followed in Clinical Practice in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 736
- 试验地点
- 20
- 主要终点
- Cohorts A and B: Conjunctival Epithelium Thickness Measured Using SD-OCT
研究概览
简要总结
The purpose of this study is to obtain conjunctiva and tenon's capsule thickness measurements in vivo using spectral domain-optical coherence tomography (SD-OCT) in participants with nAMD/DME and age-matched healthy subjects.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For nAMD/DME participants:
- •- Diagnosis of nAMD/DME
- •For healthy subjects:
- •- Normal visual function
排除标准
- •Current or past treatment for glaucoma (only for healthy subjects)
- •Dry eye disease except those treated only with artificial tears
- •Ocular hypertension treated with hypotensive drugs
- •Pterygium
- •Strabismus
- •Previous ocular surgery except cataract surgery
- •Cataract surgery with scleral incision
- •Current contact lens wearers
- •Myopia with more than 6 diopters
- •Corneal transplant
- •History of ocular surface inflammation
- •Active or recent conjunctivitis infection
- •Pregnancy
- •Participant who has already received an IVT injection in the superotemporal quadrant (only for nAMD/DME participants)
结局指标
主要结局
Cohorts A and B: Conjunctival Epithelium Thickness Measured Using SD-OCT
时间窗: At study visit (Day 1)
Cohorts A and B: Conjunctival Stroma Thickness Measured Using SD-OCT
时间窗: At study visit (Day 1)
Cohorts A and B: Tenon's Capsule Thickness Measured Using SD-OCT
时间窗: At study visit (Day 1)
Cohorts A and B: Sum of Conjunctival Epithelium Thickness, Conjunctival stroma and Tenon's Capsule Measured Using SD-OCT
时间窗: At study visit (Day 1)
Cohorts A and B: Number of Participants in Age Groups 45-54, 55-64, 65-74, >=75
时间窗: At study visit (Day 1)
次要结局
- Cohorts A and B: Scleral Thickness Measured Using SS-OCT(At study visit (Day 1))
- Cohort A: Previous Intravitreal (IVT) Injections (Yes/No)(At study visit (Day 1))
- Cohorts A and B: Conjunctival Epithelium Thickness Measured Using SS-OCT(At study visit (Day 1))
- Cohorts A and B: Conjunctival Stroma Thickness Measured Using SS-OCT(At study visit (Day 1))
- Cohorts A and B: Tenon's Capsule Thickness Measured Using SS-OCT(At study visit (Day 1))
- Cohorts A and B: Sum of Conjunctival Epithelium Thickness, Conjunctival stroma and Tenon's Capsule Measured Using SS-OCT(At study visit (Day 1))