OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

Not Applicable

• Conditions: Pediatric Idiopathic Intracranial Hypertension

• Registration Number: NCT02665858
• Lead Sponsor: Hillel Yaffe Medical Center

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 available

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-24
• Study First Submitted QC: 2016-01-24
• Last Update Submitted: 2016-01-24
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28
• Study Start: 2016-02
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Children with suspected IIH

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of RNFLT/TRT Thickness	One year

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel