Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-03 @ 7:45 PM
Study NCT ID:
NCT06031350
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2023-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripapillary and Macular Vascular Changes of Unilateral Anterior Ischemic Optic Neuropathy: An Optical Coherence Tomography Angiography Study
Sponsor:
Omar Said
Organization:
Study Overview
Official Title:
Peripapillary and Macular Vascular Changes of Unilateral Anterior Ischemic Optic Neuropathy: An Optical Coherence Tomography Angiography Study
Status:
COMPLETED
Status Verified Date:
2023-09
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:
None
Brief Summary:
This series aims at studying the peripapillary and macular vascular changes in subjects with unilateral anterior ischemic optic neuropathy via Optical Coherence Tomography Angiography (OCTA).
Detailed Description:
After approval of the local institutional ethics committee and local institutional review board, This study was conducted upon 30 patients diagnosed with acute NAION attending at Ophthalmology outpatient clinic in Fayoum University Hospitals. The participants were informed about the objectives of the study, the examination, investigations and the confidentiality of their information and their right not to participate in the study. OCT and OCTA was done for all subjects and control group with Optovue, Inc., Fremont, CA, USA. Patients were examined on presentation, after 6 weeks and lastly after 3 months. OCT was used for evaluation of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC). OCTA was done for quantitative evaluation of vessel density in the following: optic nerve head and peripapillary area, macular superficial vessel density, macular deep vessel density and foveal avascular zone. Vessel density was reported as the percentage of the total area that was occupied by blood vessels. All parameters were calculated automatically by the machine software. Poor quality scans and those with motion artifacts were excluded. Statistical analysis was performed using SPSS software (version 22; SPSS, Chicago, IL, USA). The data were presented as the mean ± SD values. P-value \<0.05 was considered significant.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: