Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SONDA.
- Who it may be relevant to
- Registry conditions: Pituitary Tumor, Visual Fields Hemianopsia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.
Detailed description
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.
Interventions
- Diagnostic test SONDA
Perimetry based visualfield analysis
Primary outcome measures
- Convert validity [Time frame: Baseline]
- Test-retest reliability [Time frame: baseline 1, baseline 2, 6-8 weeks post-operative]
Secondary outcome measures (1)
- Experience [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Neurological disorders
- Eye disease not related to a (supra)sellar tumor
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
Netherlands · 1 center
- UMCG — Groningen
Identifiers
NCT: NCT06266949 · 11362