Pituitary TumorNCT06266949
Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors
An observational study of Pituitary Tumor and Visual Fields Hemianopsia, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Tumor, Visual Fields Hemianopsia
- What is being tested?
- SONDA
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with a (supra)sellar tumour and healthy controls
Who may be able to join
- 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
Who cannot join
- Neurological disorders
- Eye disease not related to a (supra)sellar tumor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.
Read the 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.
- Conditions
- Pituitary Tumor, Visual Fields Hemianopsia
- Being tested
- SONDA
- Medical subject headings
- Pituitary Neoplasms, Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SONDADiagnostic test
Perimetry based visualfield analysis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: SONDA | |
| Healthy controls | Participants will perform the SONDA test 2 times Receives: Diagnostic Test: SONDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Convert validity
Difference (dB) between the predicted MD (SONDA) and the assessed MD (SAP), expressed as delta MD.
Measured: Baseline
Test-retest reliability
The variability of the predicted MD (dB) between consecutive measurements in the same person.
Measured: baseline 1, baseline 2, 6-8 weeks post-operative
Secondary outcomes (1)
Experience
The experience of patients expressed in scores and descriptives based on a questionnaire: Questionnaire Standardized Oculomotor and Neuro-Ophthalmic Disorder Assessment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jos MA Kuijlen, MD/PHD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266949
- Sponsor's protocol ID
- 11362
- Status last verified
- Jul 2026
- First submitted
- 25 Jan 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors
- ClinicalTrials.gov ID
- NCT06266949
- Acronym / sponsor ID
- 11362
- Conditions
- Pituitary Tumor, Visual Fields Hemianopsia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: SONDAParticipants 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 | – | Diagnostic Test: SONDAParticipants will perform the SONDA test 2 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a (supra)sellar tumour and healthy controls
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Neurological disorders
- Eye disease not related to a (supra)sellar tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SONDAPerimetry based visualfield analysis | Diagnostic test | Healthy controls, Patients |
Primary outcome
Convert validity
Time frame: Baseline
Difference (dB) between the predicted MD (SONDA) and the assessed MD (SAP), expressed as delta MD.
Test-retest reliability
Time frame: baseline 1, baseline 2, 6-8 weeks post-operative
The variability of the predicted MD (dB) between consecutive measurements in the same person.
1 secondary outcome
Experience
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jos MA Kuijlen, MD/PHD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Tumor and Visual Fields Hemianopsia, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jos MA Kuijlen, MD/PHD (050 361 2837, jmakuijlen@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Convert validity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.