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OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

Primary Purpose

Pediatric Idiopathic Intracranial Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
OCT Imaging
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pediatric Idiopathic Intracranial Hypertension

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with suspected IIH

Exclusion Criteria:

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

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IIH Patients

Control Group

Arm Description

Patients diagnosed with Idiopathic Intracranial Hypertension who undergo OCT imaging

Patients diagnosed with headache with ruled out Idiopathic Intracranial Hypertension who undergo OCT imaging

Outcomes

Primary Outcome Measures

Comparison of RNFLT/TRT Thickness

Secondary Outcome Measures

Full Information

First Posted
January 24, 2016
Last Updated
January 24, 2016
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02665858
Brief Title
OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Idiopathic Intracranial Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IIH Patients
Arm Type
Active Comparator
Arm Description
Patients diagnosed with Idiopathic Intracranial Hypertension who undergo OCT imaging
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients diagnosed with headache with ruled out Idiopathic Intracranial Hypertension who undergo OCT imaging
Intervention Type
Other
Intervention Name(s)
OCT Imaging
Primary Outcome Measure Information:
Title
Comparison of RNFLT/TRT Thickness
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with suspected IIH Exclusion Criteria: Retinal disease High refractive error Unable to undergo OCT imaging
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Cohen, MD, PhD
Phone
972-586904951
Email
dr.yuvalcohen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Cohen, MD, PhD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuval Cohen, MD, PhD
Email
dr.yuvalcohen@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

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