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Visual impairment in children with a brain tumor in the Netherlands: a prospective nationwide study using standard visual testing and optical coherence tomography

Visual impairment in children with a brain tumor in the Netherlands: a prospective nationwide study using standard visual testing and optical coherence tomography - KIZZ study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49033
Enrollment
170
Registered
2019-04-24
Start date
2019-05-15
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual decline visual impairment

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - All children, 0-18 years with any type of brain tumor - Informed and having given informed consent (either by patient and / or parents / legal guardian)

Exclusion criteria

Exclusion criteria: - Refusal by patient and / or parent / legal guardian

Design outcomes

Primary

MeasureTime frame
Main outcome measures are visual acuity (VA) (LogMar results), visual field (VF) (results of BEFIE/Humphrey peritest/non-automated static peritest/goldmann perimetrie) and changes in OCT parameters (RNFL thickness and GCL-ILP).

Secondary

MeasureTime frame
Secondary outcome parameters include visual decline (measured by the above-mentioned primary endpoints), disease status (findings on MRI) and treatment characteristics (type/frequency/dose). Expected variables at baseline are: Age, gender, ethnicity, medical (including ophthalmologic) history, neurofibromatosis 1 (yes/no), brain tumor type (histology), tumor location, tumor size and presence/absence of hydrocephalus and/or metastases. Tertiary outcome parameters include generic and cancer-specific HRQoL (measured by the Pediatric Quality of Life Inventory (PedsQL) Generic and Cancer scales) and vision-related HRQol (measured by the Participation and Activity Inventory for Children and Youth (PAI-CY)).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)