Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Convert validity
研究概览
简要总结
The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.
详细描述
The objective of this study is to determine whether SONDA is non-inferior in predicting visual field limitations compared to the SAP in patients with a (supra)sellar tumor. The study population will be made up of patients with a (supra)sellar tumor complicated by compression of the optic chiasm as well as healthy controls. The patients will be asked to join the study when the patients are referred to the UMCG for further diagnostics and treatment. In case the patients show signs of visual field loss the patients will be asked to participate in the study. The researchers will reuse data from healthy controls collected in previous studies where possible and, if necessary for age matching, recruit new participants. Participants will be asked to perform the SONDA test before and after surgery. The first time the participants will perform the test twice and will also perform routine eye test and be asked to fill in a questionnaire to evaluate the experience.
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
- •Diagnosed with a (supra)sellar tumor
- •Visual field loss based on the most recent SAP; False positive rate <15%; fixation losses <20%
- •Informed written consent
排除标准
- •Neurological disorders
- •Eye disease not related to a (supra)sellar tumor
研究组 & 干预措施
Healthy controls
Participants will perform the SONDA test 2 times
干预措施: SONDA (Diagnostic Test)
Patients
Participants will undergo a visual acuity test. Next they will perform the SONDA test 2 times at one visit and once more in a later visit Participants will fill in a questionnaire
干预措施: SONDA (Diagnostic Test)
结局指标
主要结局
Convert validity
时间窗: Baseline
Difference (dB) between the predicted MD (SONDA) and the assessed MD (SAP), expressed as delta MD.
Test-retest reliability
时间窗: baseline 1, baseline 2, 6-8 weeks post-operative
The variability of the predicted MD (dB) between consecutive measurements in the same person.
次要结局
- Experience(Baseline)
