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临床试验/NCT06266949
NCT06266949尚未招募不适用

Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年12月1日最近更新:
适应症
干预措施

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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