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

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03286426
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.4
• Patients Per Site Per Month: 0.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Intracranial Pressure Increase	Diagnostic Test: Pictor	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.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)
• Primary Purpose: Screening
• Official Title: Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure
• Actual Study Start Date: Oct 26, 2017
• Actual Primary Completion Date: Dec 8, 2018
• Actual Study Completion Date: Dec 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vision/Eye Screening Image of back of each eye along with color vision and visual acuity assessment if able.	Diagnostic Test: Pictor; 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.; Other Names: portable fundus camera

Outcome Measures

Primary Outcome Measures

1. 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]

2. Changes in Visual Acuity [Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent]

3. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke UMC	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Study Director: Sarah K Jones, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 14, 2019

More Information

Publications

• 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.
• 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.
• Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37. Review.
• 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.
• 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.
• Roberts E, Morgan R, King D, Clerkin L. Funduscopy: a forgotten art? Postgrad Med J. 1999 May;75(883):282-4.
• Sit M, Levin AV. Direct ophthalmoscopy in pediatric emergency care. Pediatr Emerg Care. 2001 Jun;17(3):199-204; quiz 205-7. Review.
• 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. Review.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03286426
• Other Study ID Numbers: Pro00083580
• First Posted: Sep 18, 2017
• Last Update Posted: Feb 15, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Duke University: vision screening; portable fundus camera; acne medication
• Additional relevant MeSH terms: Intracranial Hypertension

Study Results

Participant Flow

Arm/Group Title	Vision/Eye Screening
Arm/Group Description	Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: 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.
Period Title: Overall Study
STARTED	3
COMPLETED	0
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Vision/Eye Screening
Arm/Group Description	Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: 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.
Overall Participants	3
Age (Count of Participants)
<=18 years	3 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	59 (75)
Sex: Female, Male (Count of Participants)
Female	1 33.3%
Male	2 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	3 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 33.3%
White	2 66.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	3 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected as only one visit occurred and a change could not be measured.

Arm/Group Title	Vision/Eye Screening
Arm/Group Description	Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: 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.
Measure Participants	0

2. Primary Outcome

Title	Changes in Visual Acuity
Time Frame	Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent

Outcome Measure Data

Analysis Population Description

Data not collected as only one visit occurred and a change could not be measured.

Arm/Group Title	Vision/Eye Screening
Arm/Group Description	Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: 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.
Measure Participants	0

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected as only one visit occurred and a change could not be measured.

Arm/Group Title	Vision/Eye Screening
Arm/Group Description	Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: 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.
Measure Participants	0

Adverse Events

Time Frame	At baseline visit as only one visit occurred for each subject.
Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed as there was only one visit per subject for this study.
Arm/Group Title	Vision/Eye Screening
Arm/Group Description	Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: 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.
All Cause Mortality
	Vision/Eye Screening
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Vision/Eye Screening
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Vision/Eye Screening
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.