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

Completed

Conditions: Visual decline
10029211
visual impairment
10047518

Registration Number: NL-OMON49033

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 170

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

- Refusal by patient and / or parent / legal guardian

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main outcome measures are visual acuity (VA) (LogMar results), visual field<br /><br>(VF) (results of BEFIE/Humphrey peritest/non-automated static peritest/goldmann<br /><br>perimetrie) and changes in OCT parameters (RNFL thickness and GCL-ILP).</p><br>

Secondary Outcome Measures

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