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

Sponsor
Omar Said (Other)
Overall Status
Completed
CT.gov ID
NCT06031350
Collaborator
(none)
30
1
12.9
2.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Peripapillary and Macular Vascular Changes of Unilateral Anterior Ischemic Optic Neuropathy: An Optical Coherence Tomography Angiography Study
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 40 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, Fayoum University Fayoum Egypt

Sponsors and Collaborators

  • Omar Said

Investigators

  • Study Director: Omar Said, MD, Assistant professor of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Omar Said, Assistant professor of Ophthalmology, Fayoum University
ClinicalTrials.gov Identifier:
NCT06031350
Other Study ID Numbers:
  • EOM64
First Posted:
Sep 11, 2023
Last Update Posted:
Sep 11, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Omar Said, Assistant professor of Ophthalmology, Fayoum University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 11, 2023