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

NCT03286426 | Terminated Results FDA Device

• 1 other identifier: Pro00083580
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Intracranial Pressure Increase

Keywords

vision screening; portable fundus camera; acne medication

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Vision/Eye Screening

EXPERIMENTAL

Image of back of each eye along with color vision and visual acuity assessment if able.

Diagnostic Test: Pictor

Interventions

Pictor DIAGNOSTIC_TEST

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.

Also known as: portable fundus camera

Vision/Eye Screening

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unable or unwilling to give consent
• Over 21 years of age

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke UMC

Durham, North Carolina, 27710, United States

Location

Related Publications (8)

• 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.

  PMID: 27351182 BACKGROUND

• 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.

  PMID: 10533632 BACKGROUND

• 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.

  PMID: 11437148 BACKGROUND

• 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.

  PMID: 21998469 BACKGROUND

• 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.

  PMID: 26495382 BACKGROUND

• 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.

  PMID: 27801997 BACKGROUND

• Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37. doi: 10.2165/00128071-200506010-00004.

  PMID: 15675888 BACKGROUND

• 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.

  PMID: 9683157 BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Grace Prakalapakorn
• Organization: Duke Eye Center

grace.prakalapakorn@duke.edu

+1 919 684 7679

Study Officials

• Sarah K Jones

  Duke University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: October 26, 2017
• Primary Completion: December 8, 2018
• Study Completion: December 8, 2018
• Last Updated: February 15, 2022
• Results First Posted: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)