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OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

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ClinicalTrials.gov Identifier: NCT02665858
Recruitment Status : Not yet recruiting
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it remains a limited method of producing quantitative data in evaluating in patients with IIH.

In this study we intend to compare, by using spectral domain optical coherence tomography (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT) of the optic nerve of newly diagnosed IIH children to a control group. This will provide a quantitative measure for follow-up and treatment of this patient group.


Condition or disease Intervention/treatment
Pediatric Idiopathic Intracranial Hypertension Other: OCT Imaging

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Study Start Date : February 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: IIH Patients
Patients diagnosed with Idiopathic Intracranial Hypertension who undergo OCT imaging
Other: OCT Imaging
Active Comparator: Control Group
Patients diagnosed with headache with ruled out Idiopathic Intracranial Hypertension who undergo OCT imaging
Other: OCT Imaging


Outcome Measures

Primary Outcome Measures :
  1. Comparison of RNFLT/TRT Thickness [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with suspected IIH

Exclusion Criteria:

  • Retinal disease
  • High refractive error
  • Unable to undergo OCT imaging
Contacts and Locations

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): NCT02665858


Contacts
Contact: Yuval Cohen, MD, PhD 972-586904951 dr.yuvalcohen@gmail.com

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Yuval Cohen, MD, PhD       dr.yuvalcohen@gmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Yuval Cohen, MD, PhD Hillel Yaffe Medical Center
More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT02665858     History of Changes
Other Study ID Numbers: 0035-15-HYMC
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension
Intracranial Hypertension
Pseudotumor Cerebri
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases