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OpenTrials
Completed

NCT Number: NCT06031350

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).

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Key information

Age range

Up to 40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Fayoum University

Al Fayyum, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optical Coherence tomography angiography

Diagnostic Test

Optovue, Inc., Fremont, CA, USA

Primary outcomes

  1. Peripapillary and macular vascular changes

    Time frame: 3 months (0,6,12 weeks)

    comparing vessel density in different areas and sectors of diseased and fellow eyes

Secondary outcomes

  1. Thickness of different retinal layers

    Time frame: 3 months (0,6,12 weeks)

    comparing thickness of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC)

Sponsors and collaborators

Lead sponsor

Omar Said

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 11, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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