DRKS00019894已完成未知
Feasibility investigation of biometry measurements with new device features (Fresnel topography technique) - Fresnel feasibility investigation
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 87
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Able and willing to make the required study visit;
- •- Able and willing to provide consent and follow study instructions;
- •- Patients must have read, understood and signed the informed consent.
排除标准
- •1. Eye drops (tear fluid substitutes) used prior to the measurement (at least 2 hours without eye drops; except mydriatic agents for pupil dilatation).
- •2. Any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement.
- •3. Physical inability to be positioned at the study devices (e.g. torticollis, head tremor, etc.).
- •4. Permanent insufficient eyelid opening or eyelashes, which partially conceal alignment or keratometry reflections, inhibiting valid measurements (i.e. typical keratometry measurements with 3-4 mm zone should be ensured).
- •5. Rigid contact lenses wearing within one day prior to the measurement (if worn, lenses should be removed at least one day prior to the measurements).
- •6. Soft contact lenses wearing within one day prior to the measurement (if worn, lenses should be removed at least one day prior to the measurements).
- •7. Principal Investigator’s determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRF).
- •8. Known Pregnancy.
- •9. Patients who are participating in another ophthalmological clinical study.
研究者
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