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OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

H

Hillel Yaffe Medical Center

Status

Unknown

Conditions

Pediatric Idiopathic Intracranial Hypertension

Treatments

Other: OCT Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT02665858
0035-15-HYMC

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children with suspected IIH

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

IIH Patients
Active Comparator group
Description:
Patients diagnosed with Idiopathic Intracranial Hypertension who undergo OCT imaging
Treatment:
Other: OCT Imaging
Control Group
Active Comparator group
Description:
Patients diagnosed with headache with ruled out Idiopathic Intracranial Hypertension who undergo OCT imaging
Treatment:
Other: OCT Imaging

Trial contacts and locations

1

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Central trial contact

Yuval Cohen, MD, PhD

Data sourced from clinicaltrials.gov

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