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

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).

Study Overview

• Status: Completed
• Conditions: Non-arteritic Ischemic Optic Neuropathy
• Intervention / Treatment: Diagnostic test: Optical Coherence Tomography Angiography

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • Faculty of medicine, Fayoum university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diseased eyes; The 30 diseased eyes of the patients were considered the case group.	Diagnostic test: Optical Coherence Tomography Angiography; Optovue, Inc., Fremont, CA, USA
Fellow eyes; The 30 fellow eyes of the patients were considered the control group.	Diagnostic test: Optical Coherence Tomography Angiography; Optovue, Inc., Fremont, CA, USA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Omar Said
• Investigators: Study Director: Omar Said, MD, Assistant professor of ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 2, 2023
• First Submitted That Met QC Criteria: September 2, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: OCTA AION NAION
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ischemia; Optic Nerve Diseases; Optic Neuropathy, Ischemic
• Other Study ID Numbers: EOM64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No