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

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

NCT ID: NCT06266949

Condition: Pituitary Tumor
Visual Fields Hemianopsia

Conditions: Official terms:
Pituitary Neoplasms
Hemianopsia

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: SONDA
Description: Perimetry based visualfield analysis
Arm group label: Healthy controls
Arm group label: Patients

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.

Criteria for eligibility:

Study pop:
Patients with a (supra)sellar tumour and healthy controls

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Locations:

Facility:
Name: UMCG

Address:
City: Groningen
Zip: 9713 GZ
Country: Netherlands

Start date: August 1, 2024

Completion date: August 1, 2025

Lead sponsor:
Agency: University Medical Center Groningen
Agency class: Other

Source: University Medical Center Groningen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06266949