NCT02665858

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 24, 2016

Last Update Submit

January 24, 2016

Conditions

Pediatric Idiopathic Intracranial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Comparison of RNFLT/TRT Thickness

    One year

Study Arms (2)

IIH Patients

ACTIVE COMPARATOR

Patients diagnosed with Idiopathic Intracranial Hypertension who undergo OCT imaging

Other: OCT Imaging

Control Group

ACTIVE COMPARATOR

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

Other: OCT Imaging

Interventions

OCT ImagingOTHER
Control GroupIIH Patients

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with suspected IIH

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Study Officials

  • Yuval Cohen, MD, PhD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Cohen, MD, PhD

CONTACT

972-586904951dr.yuvalcohen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2016

First Posted

January 28, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 28, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)