Peripapillary and Macular Vascular Changes of Unilateral Anterior Ischemic Optic Neuropathy: An Optical Coherence Tomography Angiography Study

Completed

• Conditions: Non-arteritic Ischemic Optic Neuropathy
• Interventions: Diagnostic Test: Optical Coherence Tomography Angiography

• Registration Number: NCT06031350
• Lead Sponsor: Omar Said

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 Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-06-30
• Status Verified: 2023-09
• Study First Submitted: 2023-09-02
• Study First Submitted QC: 2023-09-02
• Last Update Submitted: 2023-09-02
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients diagnosed with unilateral NAION and acute or sudden painless drop of vision.
• A normal fellow eye.
• Age ≥ 40 years old.

Exclusion Criteria

• Arteritic type of AION.
• NAION patients in chronic phase.
• Acute phase NAION patients with any other optic neuropathy in the other eye.
• Eyes with opaque media.
• Elevated intraocular pressure (>22 mmHg).
• Refractive errors greater than 6 diopters of spherical equivalent.
• Poor cooperation with fixation or the OCTA examination.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fellow eyes	Optical Coherence Tomography Angiography	The 30 fellow eyes of the patients were considered the control group.
Diseased eyes	Optical Coherence Tomography Angiography	The 30 diseased eyes of the patients were considered the case group.

Primary Outcome Measures

Name	Time	Method
Peripapillary and macular vascular changes	3 months (0,6,12 weeks)	comparing vessel density in different areas and sectors of diseased and fellow eyes

Secondary Outcome Measures

Name	Time	Method
Thickness of different retinal layers	3 months (0,6,12 weeks)	comparing thickness of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC)

Trial Locations

Locations (1)

Faculty of Medicine, Fayoum University; 🇪🇬 Fayoum, Egypt