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NCT06266949 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2025

Study information
Verified date February 2024
Source University Medical Center Groningen
Contact Jos MA Kuijlen, MD/PHD
Phone 050 361 2837
Email jmakuijlen@umcg.nl
Is FDA regulated No
Health authority
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 April 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers
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

Study Design

Related Conditions & MeSH terms

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
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