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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Intracranial Pressure Increase

Intervention / Treatment
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* Diagnostic Test: Pictor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vision/Eye Screening<br>Image of back of each eye along with color vision and visual acuity assessment if able. | Diagnostic Test: Pictor<br>* The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.<br>* Other names: portable fundus camera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Posterior Segment as Measured by Fundus Camera |  | Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent | 
| Changes in Visual Acuity |  | Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent | 
| Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing) |  | Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vision screening, portable fundus camera, acne medication