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

NCT06266949 | Not Yet Recruiting

• 1 other identifier: 11362
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pituitary Tumor; Visual Fields Hemianopsia

Outcome Measures

Primary Outcomes (2)

• Convert validity

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

  Baseline

• 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 Outcomes (1)

• Experience

  Baseline

Study Arms (2)

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

Healthy controls

Participants will perform the SONDA test 2 times

Diagnostic Test: SONDA

Interventions

SONDA DIAGNOSTIC_TEST

Perimetry based visualfield analysis

Healthy controls; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a (supra)sellar tumour and healthy controls

You may qualify if:

• 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

You may not qualify if:

• Neurological disorders
• Eye disease not related to a (supra)sellar tumor

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Pituitary Neoplasms; Hemianopsia

Condition Hierarchy (Ancestors)

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

Study Officials

• Jos MA Kuijlen, MD/PHD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jos MA Kuijlen, MD/PHD

CONTACT

050 361 2837; jmakuijlen@umcg.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 20, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

NL (1)