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

NCT ID: NCT06266949

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-08-01

Brief Summary

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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

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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

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Pituitary Tumor Visual Fields Hemianopsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

SONDA

Intervention Type DIAGNOSTIC_TEST

Perimetry based visualfield analysis

Healthy controls

Participants will perform the SONDA test 2 times

SONDA

Intervention Type DIAGNOSTIC_TEST

Perimetry based visualfield analysis

Interventions

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SONDA

Perimetry based visualfield analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jos MA Kuijlen, MD/PHD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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UMCG

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Jos MA Kuijlen, MD/PHD

Role: CONTACT

050 361 2837

Other Identifiers

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11362

Identifier Type: -

Identifier Source: org_study_id

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