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NCT Number: NCT06266949

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

The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.

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Key information

Conditions

Pituitary Tumor Blindness Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Eye Diseases Hemianopsia Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pituitary Diseases Pituitary Neoplasms Sensation Disorders Signs and Symptoms Supratentorial Neoplasms Vision Disorders Visual Fields Hemianopsia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMCG

Groningen, Provincie Groningen, 9713 GZ, Netherlands

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SONDA

Diagnostic Test

Perimetry based visualfield analysis

Primary outcomes

  1. Convert validity

    Time frame: Baseline

    Difference (dB) between the predicted MD (SONDA) and the assessed MD (SAP), expressed as delta MD.

  2. 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.

Secondary outcomes

  1. Experience

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jos MA Kuijlen, MD/PHD

CONTACT

[email protected]

050 361 2837

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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