OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

Sponsor

Hillel Yaffe Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02665858

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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	Phase
Pediatric Idiopathic Intracranial Hypertension	Other: OCT Imaging	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2017

Anticipated Study Completion Date :

Feb 1, 2017

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

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

Comparison of RNFLT/TRT Thickness [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children with suspected IIH

Exclusion Criteria:

Retinal disease
High refractive error
Unable to undergo OCT imaging

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillel Yaffe Medical Center	Hadera		Israel	38100

Sponsors and Collaborators

Hillel Yaffe Medical Center

Investigators

Principal Investigator: Yuval Cohen, MD, PhD, Hillel Yaffe Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT02665858

Other Study ID Numbers:

0035-15-HYMC

First Posted:

Jan 28, 2016

Last Update Posted:

Jan 28, 2016

Last Verified:

Jan 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Intracranial Hypertension

Pseudotumor Cerebri

Hypertension

Study Results

No Results Posted as of Jan 28, 2016