Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 43 for:    Recruiting, Not yet recruiting, Available Studies | Intracranial pressure

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03286426
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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: Vision/Eye screening Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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.
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 : October 26, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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: 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.
Other Names:
  • portable fundus camera
  • Pictor




Primary Outcome Measures :
  1. 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 ]
  2. Changes in visual acuity [ Time Frame: 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) [ Time Frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286426


Contacts
Layout table for location contacts
Contact: Sasapin G Prakalapakorn, MD (919)684-2038 grace.prakalapakorn@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke UMC Recruiting
Durham, North Carolina, United States, 27710
Contact: Sasapin G Prakalapakorn, MD, MPH    919-684-7679    grace.prakalapakorn@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Study Director: Sarah K Jones Duke University

Publications:
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03286426     History of Changes
Other Study ID Numbers: Pro00083580
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
Layout table for MeSH terms
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases