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

U

University Medical Center Groningen (UMCG)

Status

Not yet enrolling

Conditions

Visual Fields Hemianopsia
Pituitary Tumor

Treatments

Diagnostic Test: SONDA

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Patients
Description:
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
Treatment:
Diagnostic Test: SONDA
Healthy controls
Description:
Participants will perform the SONDA test 2 times
Treatment:
Diagnostic Test: SONDA

Trial contacts and locations

1

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Central trial contact

Jos MA Kuijlen, MD/PHD

Data sourced from clinicaltrials.gov

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