Clinical trial NCT03286426: Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure
Official title: Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intracranial Pressure Increase
Keywords: vision screening
portable fundus camera
acne medication
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 3
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will have images taken of the back of the eye with a portable fundus camera. If able, visual acuity and color vision will be checked.
Primary purpose: SCREENING

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Posterior Segment as Measured by Fundus Camera
timeFrame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
measure: Changes in Visual Acuity
timeFrame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
measure: Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)
timeFrame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke UMC
state: North Carolina
Study officials:
affiliation: Duke University
name: Sarah K Jones
role: STUDY_DIRECTOR
References:
citation: Xu W, Gerety P, Aleman T, Swanson J, Taylor J. Noninvasive methods of detecting increased intracranial pressure. Childs Nerv Syst. 2016 Aug;32(8):1371-86. doi: 10.1007/s00381-016-3143-x. Epub 2016 Jun 28.
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citation: Sit M, Levin AV. Direct ophthalmoscopy in pediatric emergency care. Pediatr Emerg Care. 2001 Jun;17(3):199-204; quiz 205-7. doi: 10.1097/00006565-200106000-00013.
citation: Petrushkin H, Barsam A, Mavrakakis M, Parfitt A, Jaye P. Optic disc assessment in the emergency department: a comparative study between the PanOptic and direct ophthalmoscopes. Emerg Med J. 2012 Dec;29(12):1007-8. doi: 10.1136/emermed-2011-200038. Epub 2011 Oct 13.
citation: Golshani K, Ebrahim Zadeh M, Farajzadegan Z, Khorvash F. Diagnostic Accuracy of Optic Nerve Ultrasonography and Ophthalmoscopy in Prediction of Elevated Intracranial Pressure. Emerg (Tehran). 2015 Spring;3(2):54-8.
citation: Day LM, Wang SX, Huang CJ. Nonmydriatic Fundoscopic Imaging Using the Pan Optic iExaminer System in the Pediatric Emergency Department. Acad Emerg Med. 2017 May;24(5):587-594. doi: 10.1111/acem.13128. Epub 2017 Mar 24.
citation: Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37. doi: 10.2165/00128071-200506010-00004.
citation: Chiu AM, Chuenkongkaew WL, Cornblath WT, Trobe JD, Digre KB, Dotan SA, Musson KH, Eggenberger ER. Minocycline treatment and pseudotumor cerebri syndrome. Am J Ophthalmol. 1998 Jul;126(1):116-21. doi: 10.1016/s0002-9394(98)00063-4.