Optical coherence tomography in non-syndromic craniosynostosis patients

Children with craniosynostosis are at risk for increased intracranial
pressure(ICP), particularly during the first 6 years of life.Increased ICP is
routinely determined through fundoscopy, indicated by the presence of
papilledema. The drawback of fundoscopy is the fact that this is an observer
dependant and qualitative method Optical coherence tomography has a high
potential as a screening tool for elevated intracranial pressure in
craniosynostosis. The big advantage of OCT is that it is a quantitative method
which is observer-independent
In our previous study on patients with a congenital disorder of the skull
(craniosynostosis), we have used OCT and found a significant difference for
children with this disorder and papilledema compared to those patients without
papilledema. Papilledema results from axonal stasis secondary to raised ICP. We
recently established the normative reference values for children aged 4 to 10
years of age. With these data, we can compare our data from the
craniosynostosis cohort and start using OCT as a tool in clinical treatment.

The primary objective is to obtain OCT data for children aged 4 to 10 diagnosed
with non-syndromic craniosynostosis and to compare these to the normal
reference values.

In this cohort study, an OCT scan will be made in non-synromic craniosynostosis
patients aged 4 to 10. The investigator will contact the parents by mail at
least 1 week prior to their appointment. The parent will receive the patient
information file and be asked for their permission to have their child
participate in our study. If consent is given, the investigator will accompany
the patient and parents to the OCT and take the image.
. The child has to focus on a red light for a few seconds during which the
images are captured. The child*s pupils are dilated with eye drops to
facilitate the image capturing with the OCT. Because dilation of the pupils is
associated with some discomfort such as temporarily blurred vision, only
children who*s pupils have already been dilated because of the fundoscopy for
which they visit the department of Ophthalmology are asked to participate.
Based on a power analysis done by a statistician we want to obtain a group of
90 children with a non-syndromic craniosynostosis. In our previous study we
already collected the OCT data of 35 non-syndromic patients. We want to combine
the OCT data of the newly referred participants with the already existing OCT
data and compare them to the reference values we obtained in our other study.
Therefore, we want to include another 55 non-syndromic patients in our study in
a time period of 6 months.

The children that participate do not require additional eye drops for dilating
the pupil. They only have to focus at a red light for a few seconds without
blinking. The OCT doesn't cause any pain, radiation or other burden to the
child. No extra hospital visit is required. As the OCT is situated at the
department of Opthalmology, the extra time spend because of this measurement is
very limited. This study does involve a non-therapeutic study in minors, but
with negligible risks and minimal burden. The investigator is present during
the investigation and will stop the procedure whenever the child's behavior
requires so, according to the "Code of conduct relating to expressions of
objection by minors participating in medical research".