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

May 1, 2025 updated by: University Medical Center Groningen
The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a (supra)sellar tumour and healthy controls

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: SONDA
Perimetry based visualfield analysis
Healthy controls
Participants will perform the SONDA test 2 times
Diagnostic test: SONDA
Perimetry based visualfield analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Convert validity
Time Frame: Baseline
Difference (dB) between the predicted MD (SONDA) and the assessed MD (SAP), expressed as delta MD.
Baseline
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.
baseline 1, baseline 2, 6-8 weeks post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Jos MA Kuijlen, MD/PHD, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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