Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any - 21
Updated:9/14/2018
Start Date:October 26, 2017
End Date:September 30, 2019
Contact:Sasapin G Prakalapakorn, MD
Email:grace.prakalapakorn@duke.edu
Phone:(919)684-2038

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The purpose of this study is to evaluate the vision and posterior segment of eyes in children
and young adults less than 22 years of age with risk, suspicion, or past medical history
significant for elevated intracranial pressure (ICP). Patients will have visual acuity and
color vision tested. Assessment of the posterior segment will involve using a non-invasive
(non-contact) imaging technique (i.e. a portable fundus camera in clinic and hospital
settings).

The need for non-invasive evaluation of ICP is an active area of study. The current gold
standard is intraventricular or intraparenchymal catheters but these are invasive, expensive,
and require sedation; and thus the need for an effective non-invasive screening tool. The
utility of funduscopy in identifying processes affecting ICP has long been recognized, i.e.
papilledema, ocular venous engorgement, blurring of the optic disk. Studies have demonstrated
that funduscopy may have a role in the qualitative assessment of increased ICP as a highly
sensitive test. However, conventional bedside funduscopy does not allow for image capture and
may necessitate pupillary dilation. Portable fundus cameras address these issues, allowing
image capture and storage and the potential for non-mydriatic imaging, i.e. imaging without
dilation of eyes. And as demonstrated in a recent study, portable fundus cameras are
efficient (median exam time was 3 minutes and 24 seconds in a pediatric Emergency
Department).

Additionally, ICP screening in asymptomatic patients remains limited. Patients being treated
with medications for acne, specifically tetracyclines (e.g. minocycline and doxycycline),
retinol, and isotretinol, are at particular risk for increased ICP but often are not
identified until they are symptomatic (i.e. headaches, visual loss, papilledema). Symptom
onset has been documented from 2 weeks up to 1 year from drug initiation. The percentage of
patients with subclinical asymptomatic disease is unclear. This study would allow us to
describe the presence of subclinical disease in our population and the role/utility of
routine non-invasive screening methods.

Inclusion Criteria:

- Capable and willing to provide consent

- Less than 22 years of age

- History of or suspicion for elevated ICP or starting/currently taking high-risk
medications associated with increased risk for elevated ICP

Exclusion Criteria:

- Unable or unwilling to give consent

- Over 21 years of age
We found this trial at
1
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Durham, North Carolina 27710
Phone: 919-684-7679
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