Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT01614158
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2012-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy
Sponsor:
University Hospital Tuebingen
Organization:
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 2,8 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 2,8 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:
False
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?: