Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Perimetry changes over the years
研究概览
简要总结
The ophthalmic changes during long-lasting sleep apnea are lacking in description and assessment. The investigators intend to observe patients for a long time and observe if the changes in eye tissues are progressing over the years in easily recognizable patterns.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy,
- •ongoing treatment of sleep apnea with positive airway pressure therapy,
- •patients older than 18 years,
- •signed inform consent
排除标准
- •pregnant and breastfeeding persons
结局指标
主要结局
Perimetry changes over the years
时间窗: 10 years
Changes in retinal sensitivity (measured in decibels/ dB) during observation time measured by standard automated perimetry. The manner of presentation of overall descriptors auch as: mean deviation (MD; dB) and pattern standard deviation (PSD; dB) will be recorded.
Flicker defined form perimetry changes over the years
时间窗: 10 years
Changes in retinal sensitivity (measured in decibels/ dB) during observation time measured by standard automated perimetry with flicker defined form signal. The manner of presentation of overall descriptors auch as: mean deviation (MD; dB) and pattern standard deviation (PSD; dB) will be recorded.
RareBit perimetry changes over the years
时间窗: 10 years
Changes in Changes in retinal sensitivity (measured in percentage of all presented excitors/ %) during observation time measured by RareBit signal perimetry. The manner of presentation of overall descriptors auch as: mean hit rate (MHR; %), area under 90% (%) and sectorial mean miss rate (MMR; %) will be recorded.
次要结局
- Epworth Sleepiness Scale(10 years)
- Pittsburgh Sleep Quality Index(10 years)
- Macular changes in optical coherent tomography (OCT)(10 years)
- Disc damage likelihood scale (DDLS)(10 years)
- Functional Outcomes of Sleep Questionnaire(10 years)
- Change in thickness of the retinal nerve fibre layer (RNFL)(10 years)
- Change in the optic nerve morphology - standard chart of HRT(10 years)
- AREDS 2008 Clinical Lens Opacity Grading Procedure(10 years)
研究者
Joanna Przeździecka-Dołyk
Investigator
Wroclaw Medical University