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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06031350
Enrollment
30
Registered
2023-09-11
Start date
2021-06-01
Completion date
2022-06-30
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-arteritic Ischemic Optic Neuropathy

Keywords

OCTA AION NAION

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.

Interventions

DIAGNOSTIC_TESTOptical Coherence Tomography Angiography

Optovue, Inc., Fremont, CA, USA

Sponsors

Omar Said
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Peripapillary and macular vascular changes3 months (0,6,12 weeks)comparing vessel density in different areas and sectors of diseased and fellow eyes

Secondary

MeasureTime frameDescription
Thickness of different retinal layers3 months (0,6,12 weeks)comparing thickness of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026