Pituitary Tumor, Visual Fields Hemianopsia
Conditions
Brief summary
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_TESTSONDA
Perimetry based visualfield analysis
Sponsors
University Medical Center Groningen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Convert validity | Baseline | Difference (dB) between the predicted MD (SONDA) and the assessed MD (SAP), expressed as delta MD. |
| Test-retest reliability | baseline 1, baseline 2, 6-8 weeks post-operative | The variability of the predicted MD (dB) between consecutive measurements in the same person. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Experience | Baseline | The experience of patients expressed in scores and descriptives based on a questionnaire: Questionnaire Standardized Oculomotor and Neuro-Ophthalmic Disorder Assessment |
Countries
Netherlands
Contacts
CONTACTJos MA Kuijlen, MD/PHD
PRINCIPAL_INVESTIGATORJos MA Kuijlen, MD/PHD
University Medical Center Groningen
Outcome results
None listed