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OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

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. Read our disclaimer for details. Identifier: NCT02665858
Recruitment Status : Unknown
Verified January 2016 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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 Phase
Pediatric Idiopathic Intracranial Hypertension Other: OCT Imaging Not Applicable

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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

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

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

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

Inclusion Criteria:

  • Children with suspected IIH

Exclusion Criteria:

  • Retinal disease
  • High refractive error
  • Unable to undergo OCT imaging

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 identifier (NCT number): NCT02665858

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Contact: Yuval Cohen, MD, PhD 972-586904951

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Hillel Yaffe Medical Center
Hadera, Israel, 38100
Contact: Yuval Cohen, MD, PhD   
Sponsors and Collaborators
Hillel Yaffe Medical Center
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Principal Investigator: Yuval Cohen, MD, PhD Hillel Yaffe Medical Center

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Responsible Party: Hillel Yaffe Medical Center Identifier: NCT02665858    
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:
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Intracranial Hypertension
Pseudotumor Cerebri
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases