NCT03070717已完成不适用
High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Change in retinal morphology by SD-OCT
研究概览
简要总结
This research project intends to observe patients with high myopia who show pathological retinal changes, in order to evaluate more data on the risk factors for developing mCNV within this research project population in Germany.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female caucasian patients ≥ 18 years of age
- •Diagnosis of high myopia secondary to an anterior-posterior elongation of the bulbus confirmed by ocular examination in either eye using the following criteria:
- •Ocular ultrasonography or biometry demonstrating anterior-posterior elongation measurement ≥ 26 mm
- •abnormal change in retinal tissue by SD-OCT that are attributed to be caused by high myopia as shown in Table 4-2 of the protocol in the investigator's discretion confirmed by the reading centre
排除标准
- •Patients with Diabetes mellitus of any grade
- •Patients showing signs of Age-Related Macular Degeneration (AMD), e.g. drusen, characteristic changes in fundus (with shaping or extension of hemorrhages, fibrosis, exudative areas) in either eye
- •Acute neovascularization (CNV or iris neovascularization) and intra- or subretinal fluid in either eye at the time of enrolment.
- •History of inactive CNV in study eye. Inactive CNV of fellow eye is allowed if treatment was performed more than 12 months before enrolment.
- •Any anti vascular endothelial growth factor' (anti-VEGF) or Verteporfin treatment in study eye and anti-VEGF or Verteporfin treatment less than 12 months before enrolment in fellow eye
- •History of systemic anti vascular endothelial growth factor' (anti-VEGF) therapy
- •Cataract that would prevent an accurate measurement of the axial length of the study eye
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Change in retinal morphology by SD-OCT
时间窗: Baseline, first year, 2nd year, 3rd year
To exploratively determine the pathogenesis within the project population by assessing and evaluating the risk factors of myopic CNV by measuring the change in retinal morphology with spectral domain optical coherence tomography (SD-OCT). Risk factors are defined as choroidal thinning \< 50μm, choroidal curvature length \> 6300 μm (nasal temporal), lacquer cracks, patchy atrophy \> 5mm² and preexisting myopic CNV in second eye.
次要结局
- Change in retinal morphology by fundus autofluorescence(Baseline, first year, 2nd year, 3rd year)
- Change in retinal morphology by fundus photography(Baseline, first year, 2nd year, 3rd year)
- Change in refraction error by autorefractometer(Baseline, 3rd year)
- Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent)(Baseline, 3rd year)
研究者
研究点 (1)
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