CClinicalTrials.gg
Status unknownNCT02665858Updated Jan 28, 2016

OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

An interventional study of OCT Imaging in Pediatric Idiopathic Intracranial Hypertension, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pediatric Idiopathic Intracranial Hypertension
03

In context

Intracranial Hypertension

185 studies on the registry are indexed under Intracranial Hypertension; 45 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 95 interventional studies indexed under Intracranial Hypertension.

Browse Intracranial Hypertension studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children with suspected IIH

Exclusion criteria

Exclusion Criteria:

  • Retinal disease
  • High refractive error
  • Unable to undergo OCT imaging
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • OtherOCT Imaging
06

What researchers measure

Primary outcomes

  1. Comparison of RNFLT/TRT Thickness

    Time frame: One year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02665858
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Jan 28, 2016
Start date
Feb 2016
Primary completion
Feb 2017 (estimated)
Completion
Feb 2017 (estimated)
Last update
Jan 28, 2016

Study contacts

Yuval Cohen, MD, PhD
Contact
dr.yuvalcohen@gmail.com
972-586904951
Yuval Cohen, MD, PhD
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion