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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Tracking Information
First Submitted Date  ICMJE January 24, 2016
First Posted Date  ICMJE January 28, 2016
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2016)
Comparison of RNFLT/TRT Thickness [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Pediatric Idiopathic Intracranial Hypertension
Intervention  ICMJE Other: OCT Imaging
Study Arms  ICMJE
  • Active Comparator: IIH Patients
    Patients diagnosed with Idiopathic Intracranial Hypertension who undergo OCT imaging
    Intervention: Other: OCT Imaging
  • Active Comparator: Control Group
    Patients diagnosed with headache with ruled out Idiopathic Intracranial Hypertension who undergo OCT imaging
    Intervention: Other: OCT Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 24, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children with suspected IIH

Exclusion Criteria:

  • Retinal disease
  • High refractive error
  • Unable to undergo OCT imaging
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02665858
Other Study ID Numbers  ICMJE 0035-15-HYMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hillel Yaffe Medical Center
Study Sponsor  ICMJE Hillel Yaffe Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuval Cohen, MD, PhD Hillel Yaffe Medical Center
PRS Account Hillel Yaffe Medical Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP