The objective of this study is to establish normative data on OCT in children between the ages of 4 to 10.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
- Increased intracranial pressure and hydrocephalus
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will provide normative data on retinal layer thickness per year of age for
children in between 4 to 10 years of age. The endpoint is reached when we have
gathered 5 children for each age.
Secondary outcome
Not applicable
Background summary
Optical coherence tomography is a rather new method to assess the thickness of
the retina. One of the applications concerns the quantification of the retinal
layer thickness as a measure for increased intracranial pressure (ICP).
Increased ICP is routinely determined through fundoscopy, indicated by the
presence of papilledema. The drawbacks of fundoscopie is the fact that this is
an observer dependant and qualitative method. The advantages of OCT are its
objective measurements and quantification. However, norm data for children are
lacking while these are needed for interpretation of data obtained in children
with disorders that affect the retinal layer.
Study objective
The objective of this study is to establish normative data on OCT in children
between the ages of 4 to 10.
Study design
From an earlier study in children with craniosynostosis we experienced that
obtaining an OCT measurement in children from the age of 4 years is very
feasible. The OCT uses near infrared light which is able to penetrate tissue
without causing damage and is thus able to measure the thickness of the retinal
layer. 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 clinical
indication for which they visit the department of Ophthalmology are asked to
participate.
A child that wants to participate and whose parents have given consent will be
asked to place the head on a headrest and focus on a red light for a few
seconds without blinking.
Study burden and risks
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 Ophthalmology, 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 behaviour
requires so, according to the *Code of conduct relating to expressions of
objection by minors participating in medical research*.
Dr Molewaterplein 60
Rotterdam 3015GJ
NL
Dr Molewaterplein 60
Rotterdam 3015GJ
NL
Listed location countries
Age
Inclusion criteria
- Aged 4 to 10 years of age
- Have dilated pupils because of the clinical examination for which the child is referred
Exclusion criteria
A condition that is likely to affect retinal layer thickness will be an exclusion criterium.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47389.078.14 |