Ophthalmological Screening and Follow-up of Optic Pathway Gliomas in Children With Neurofibromatosis Type 1.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Dr. Catherine Cassiman, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
First received: February 26, 2014
Last updated: July 1, 2014
Last verified: July 2014
The goal of this project is to get more insight into the (neuro)ophthalmological characteristics of children with neurofibromatosis type 1. This way investigators would like to update the current guidelines for follow up and treatment of optic pathway gliomas. Clinical findings will be compared with the results of Optical coherence tomography (OCT) and MRI (magnetic resonance imaging).

Neurofibromatosis Type 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ophthalmological Screening and Follow-up of Optic Pathway Gliomas in Children With Neurofibromatosis Type 1.

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: childhood (0 to 18y) ] [ Designated as safety issue: No ]
  • Presence of optic pathway glioma [ Time Frame: childhood (0 to18y) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Neurofibromatosis type 1 children


Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with neurofibromatosis type 1 with and without optic pathway glioma

Inclusion Criteria:

  • neurofibromatosis type 1

Exclusion Criteria:

  • no neurofibromatosis type 1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078401

Contact: Catherine Cassiman, MD 00321632660 catherine.cassiman@uzleuven.be

University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Principal Investigator: Catherine Cassiman, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Catherine Cassiman, MD Universitaire Ziekenhuizen Leuven
  More Information

Responsible Party: Dr. Catherine Cassiman, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02078401     History of Changes
Other Study ID Numbers: S56406 
Study First Received: February 26, 2014
Last Updated: July 1, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Optic pathway glioma
Ophthalmological screening

Additional relevant MeSH terms:
Neurofibromatosis 1
Optic Nerve Glioma
Cranial Nerve Diseases
Cranial Nerve Neoplasms
Eye Diseases
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplastic Syndromes, Hereditary
Nerve Sheath Neoplasms
Nervous System Diseases
Nervous System Neoplasms
Neurocutaneous Syndromes
Neurodegenerative Diseases
Neuroectodermal Tumors
Neuromuscular Diseases
Optic Nerve Diseases
Optic Nerve Neoplasms
Peripheral Nervous System Diseases
Peripheral Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 04, 2016