Pediatric Idiopathic Intracranial Hypertension Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 50 |
| Est. completion date | February 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 5 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - Children with suspected IIH Exclusion Criteria: - Retinal disease - High refractive error - Unable to undergo OCT imaging |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hillel Yaffe Medical Center | Hadera |
| Lead Sponsor | Collaborator |
|---|---|
| Hillel Yaffe Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparison of RNFLT/TRT Thickness | One year | No |