NCT06031350

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

September 2, 2023

Last Update Submit

September 2, 2023

Conditions

Non-arteritic Ischemic Optic Neuropathy

Keywords

OCTA AION NAION

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Thickness of different retinal layers

    3 months (0,6,12 weeks)

Study Arms (2)

Diseased eyes

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

Diagnostic Test: Optical Coherence Tomography Angiography

Fellow eyes

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

Diagnostic Test: Optical Coherence Tomography Angiography

Interventions

Optical Coherence Tomography AngiographyDIAGNOSTIC_TEST

Optovue, Inc., Fremont, CA, USA

Diseased eyesFellow eyes

Eligibility Criteria

AgeUp to 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients presenting to the outpatient clinic of the department of Ophthalmology in Fayoum university hospitals with unilateral acute NAION. 30 patients (60 eyes) divided into 2 groups: 30 NAION eyes as the case group, and 30 fellow eyes as a control group.

You may qualify if:

  • Patients diagnosed with unilateral NAION and acute or sudden painless drop of vision.
  • A normal fellow eye.
  • Age ≥ 40 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Fayoum University

Al Fayyum, Egypt

Location

Study Officials

  • Omar Said, MD

    Assistant professor of Ophthalmology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of Ophthalmology

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 11, 2023

Study Start

June 1, 2021

Primary Completion

May 31, 2022

Study Completion

June 30, 2022

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

EG(1)