An observational study in Non-arteritic Ischemic Optic Neuropathy, sponsored by Omar Said. Completed at 1 site in Egypt. Open to participants aged Up to 40 Years. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Omar Said · Observational
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).
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.
128 studies on the registry are indexed under Optic Nerve Diseases; 27 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 35 observational studies indexed under Optic Nerve Diseases.
Browse Optic Nerve Diseases studies →Omar Said is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Patients presenting to the outpatient clinic of the department of Ophthalmology in Fayoum university hospitals with unilateral acute NAION. 30 patients (60 eyes) divided into 2 groups: 30 NAION eyes as the case group, and 30 fellow eyes as a control group.
Exclusion Criteria:
The 30 diseased eyes of the patients were considered the case group.
Diagnostic Test: Optical Coherence Tomography Angiography
The 30 fellow eyes of the patients were considered the control group.
Diagnostic Test: Optical Coherence Tomography Angiography
Optovue, Inc., Fremont, CA, USA
Peripapillary and macular vascular changes
comparing vessel density in different areas and sectors of diseased and fellow eyes
Time frame: 3 months (0,6,12 weeks)
Thickness of different retinal layers
comparing thickness of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC)
Time frame: 3 months (0,6,12 weeks)
Plan to share: Undecided
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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