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

Not yet recruiting

• Conditions: Pituitary Tumor; Visual Fields Hemianopsia
• Interventions: Diagnostic Test: SONDA

• Registration Number: NCT06266949
• Lead Sponsor: University Medical Center Groningen

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.

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-20
• Status Verified: 2024-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Study Start: 2025-08-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	SONDA	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
Healthy controls	SONDA	Participants will perform the SONDA test 2 times

Primary Outcome Measures

Name	Time	Method
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.
Convert validity	Baseline	Difference (dB) between the predicted MD (SONDA) and the assessed MD (SAP), expressed as delta MD.

Secondary Outcome Measures

Name	Time	Method
Experience	Baseline	The experience of patients expressed in scores and descriptives based on a questionnaire: Questionnaire Standardized Oculomotor and Neuro-Ophthalmic Disorder Assessment

Trial Locations

Locations (1)

UMCG; 🇳🇱 Groningen, Netherlands