Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure (ICP)
Primary Purpose
Intracranial Pressure Increase
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pictor
Sponsored by
About this trial
This is an interventional screening trial for Intracranial Pressure Increase focused on measuring vision screening, portable fundus camera, acne medication
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
Sites / Locations
- Duke UMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vision/Eye Screening
Arm Description
Image of back of each eye along with color vision and visual acuity assessment if able.
Outcomes
Primary Outcome Measures
Changes in Posterior Segment as Measured by Fundus Camera
Changes in Visual Acuity
Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03286426
Brief Title
Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure
Acronym
ICP
Official Title
Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
December 8, 2018 (Actual)
Study Completion Date
December 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Increase
Keywords
vision screening, portable fundus camera, acne medication
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vision/Eye Screening
Arm Type
Experimental
Arm Description
Image of back of each eye along with color vision and visual acuity assessment if able.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pictor
Other Intervention Name(s)
portable fundus camera
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Posterior Segment as Measured by Fundus Camera
Time Frame
Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Title
Changes in Visual Acuity
Time Frame
Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Title
Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)
Time Frame
Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah K Jones
Organizational Affiliation
Duke University
Official's Role
Study Director
Facility Information:
Facility Name
Duke UMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27351182
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.
Results Reference
background
PubMed Identifier
10533632
Citation
Roberts E, Morgan R, King D, Clerkin L. Funduscopy: a forgotten art? Postgrad Med J. 1999 May;75(883):282-4. doi: 10.1136/pgmj.75.883.282.
Results Reference
background
PubMed Identifier
11437148
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.
Results Reference
background
PubMed Identifier
21998469
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.
Results Reference
background
PubMed Identifier
26495382
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.
Results Reference
background
PubMed Identifier
27801997
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.
Results Reference
background
PubMed Identifier
15675888
Citation
Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37. doi: 10.2165/00128071-200506010-00004.
Results Reference
background
PubMed Identifier
9683157
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.
Results Reference
background
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Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure
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