Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01614158
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2012-06-04
Brief Title:
Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Pilot SINN Assessment of Visual Field vf-Related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy N-AION
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pilot-SINN
Brief Summary:
This present research project intends to collect five quantitative test series
perimetric examination using static stimuli assessing the entire 80 degree visual field with a fast thresholding algorithm GATE Schiefer 2008 to know the extent magnitude of the visual field defect and its variability within the cohort and over time
D-BCVA using FrACT Bach 2007 and EDTRS chart Ferris 1982
RAPD using swinging flashlight test
IOP using applanation tonometer
RNFT and RNFV using Spectralis OCT star scan ring scan 28 mm and volume scan Optic disk morphology will be documented by fundus photography This assessment of the above-mentioned data is needed in order to allow for estimation of the spontaneous course fluctuation of the quantified functional and morphometric parameters of the N-AION patients during the follow-up period This is essential for the estimation of the sample size of the subsequently intended SINN study that is intended to compare different therapeutic strategies in N-AION patients
perimetric examination using static stimuli assessing the entire 80 degree visual field with a fast thresholding algorithm GATE Schiefer 2008 to know the extent magnitude of the visual field defect and its variability within the cohort and over time
D-BCVA using FrACT Bach 2007 and EDTRS chart Ferris 1982
RAPD using swinging flashlight test
IOP using applanation tonometer
RNFT and RNFV using Spectralis OCT star scan ring scan 28 mm and volume scan Optic disk morphology will be documented by fundus photography This assessment of the above-mentioned data is needed in order to allow for estimation of the spontaneous course fluctuation of the quantified functional and morphometric parameters of the N-AION patients during the follow-up period This is essential for the estimation of the sample size of the subsequently intended SINN study that is intended to compare different therapeutic strategies in N-AION patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None