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OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02665858
Enrollment
50
Registered
2016-01-28
Start date
2016-02-29
Completion date
2017-02-28
Last updated
2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Idiopathic Intracranial Hypertension

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.

Interventions

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Children with suspected IIH

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Comparison of RNFLT/TRT ThicknessOne year

Countries

Israel

Contacts

Primary ContactYuval Cohen, MD, PhD
dr.yuvalcohen@gmail.com972-586904951

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026