OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02665858|
Recruitment Status : Unknown
Verified January 2016 by Hillel Yaffe Medical Center.
Recruitment status was: Not yet recruiting
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Idiopathic Intracranial Hypertension||Other: OCT Imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||February 2017|
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
- Comparison of RNFLT/TRT Thickness [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665858
|Contact: Yuval Cohen, MD, PhDemail@example.com|
|Hillel Yaffe Medical Center||Not yet recruiting|
|Hadera, Israel, 38100|
|Contact: Yuval Cohen, MD, PhD firstname.lastname@example.org|
|Principal Investigator:||Yuval Cohen, MD, PhD||Hillel Yaffe Medical Center|