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

Pituitary Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06266949
• Other study ID #: 11362
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: Jos MA Kuijlen, MD/PHD
• Phone: 050 361 2837
• Email: jmakuijlen[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2025
• Est. primary completion date: April 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemianopsia
• Pituitary Neoplasms
• Pituitary Tumor
• Visual Fields Hemianopsia

Intervention

Diagnostic Test:
• SONDA
Perimetry based visualfield analysis

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Convert validity	Difference (dB) between the predicted MD (SONDA) and the assessed MD (SAP), expressed as delta MD.	Baseline
Primary	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	Experience	The experience of patients expressed in scores and descriptives based on a questionnaire: Questionnaire Standardized Oculomotor and Neuro-Ophthalmic Disorder Assessment	Baseline