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

Non-arteritic Ischemic Optic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06031350
• Other study ID #: EOM64
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2023
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Non-arteritic Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Diagnostic Test:
• Optical Coherence Tomography Angiography
Optovue, Inc., Fremont, CA, USA

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Fayoum University	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Omar Said

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)