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

NCT ID: NCT06031350

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-06-30

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.

Conditions

Non-arteritic Ischemic Optic Neuropathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Diseased eyes

The 30 diseased eyes of the patients were considered the case group.

Optical Coherence Tomography Angiography

Intervention Type: DIAGNOSTIC_TEST

Optovue, Inc., Fremont, CA, USA

Fellow eyes

The 30 fellow eyes of the patients were considered the control group.

Optical Coherence Tomography Angiography

Intervention Type: DIAGNOSTIC_TEST

Optovue, Inc., Fremont, CA, USA

Interventions

Optical Coherence Tomography Angiography

Optovue, Inc., Fremont, CA, USA

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omar Said

OTHER

Sponsor Role: lead

Responsible Party

Omar Said

Assistant professor of Ophthalmology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Omar Said, MD

Role: STUDY_DIRECTOR

Assistant professor of Ophthalmology

Locations

Faculty of Medicine, Fayoum University

Al Fayyum, , Egypt

Countries

Egypt

Other Identifiers

EOM64

Identifier Type: -

Identifier Source: org_study_id