Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2024
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedMay 2, 2025
May 1, 2024
8 months
January 25, 2024
May 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Convert validity
Difference (dB) between the predicted MD (SONDA) and the assessed MD (SAP), expressed as delta MD.
Baseline
Test-retest reliability
The variability of the predicted MD (dB) between consecutive measurements in the same person.
baseline 1, baseline 2, 6-8 weeks post-operative
Secondary Outcomes (1)
Experience
Baseline
Study Arms (2)
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
Healthy controls
Participants will perform the SONDA test 2 times
Interventions
Eligibility Criteria
Patients with a (supra)sellar tumour and healthy controls
You may qualify if:
- 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
You may not qualify if:
- Neurological disorders
- Eye disease not related to a (supra)sellar tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMCG
Groningen, Provincie Groningen, 9713 GZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jos MA Kuijlen, MD/PHD
University Medical Center Groningen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2024
First Posted
February 20, 2024
Study Start
August 1, 2025
Primary Completion
April 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
May 2, 2025
Record last verified: 2024-05