NA-AION Risk Factors: New Perspectives

Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05305079

Acronym

NARROW

Enrollment

179

Registered

2022-03-31

Start date

2021-08-01

Completion date

2024-08-31

Last updated

2024-11-22

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, Optic Disk Drusen

Keywords

Optical Coherence Tomography, Optical Coherence Tomography Angiography

Brief summary

The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve.

Detailed description

Non-arteritic anterior ischemic optic neuropathy (NA-AION) is the most common acute optic neuropathy in the middle-aged and elderly population and can also occur in children and young adults. NA-AION leads to irreversible vision loss, and there is currently no effective treatment. In recent years, acellular calcified deposits in the optic nerve head called optic disc drusen (ODD) have been investigated as an important risk factor for NA-AION in patients under the age of 50. The purpose of the study is to use new diagnostic methods optical coherence tomography (OCT) and OCT-angiography (OCTA) to shed light on risk factors for the development of NA-AION. We will perform two sub-studies: 1. Characteristics of the optic nerve head anatomy including the presence of ODD as risk factors for the development of NA-AION. 2. Vascular comorbidities and in vivo vasculature as a risk factor for developing NA-AION. The study is an international prospective multicenter study including 20 sites in 9 different countries. The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period. Each included patient gets 1-2 follow up visits during a 3-month follow up time. Included patients will be examined as per standard clinical care for that site including OCT and OCT-A. Standard clinical care includes at least: obtaining medical history, measurement of visual acuity, slit lamp examination, and automated perimetry. Characteristics and risk factors in NA-AION patients with ODD (ODD-AION) will be compared with NA-AOIN patients without ODD (nODD-AION).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

11 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Diagnosis of first episode of NA-AION in study eye with symptom onset within 1 month prior 2. Subject age: Age \>10 3. NA-AION diagnosis requires: * disc edema seen by site PI or by referring doctor * visual field defect in the study eye consistent with NA-AION and mean deviation worse than 3.0 dB using the study visual field examination protocol * relative afferent pupillary defect (unless the fellow eye had previous NA-AION or other optic nerve or retinal disease that is not exclusionary)

Exclusion criteria

1. Previous episode of NA-AION in the study eye only 2. Intraocular pressure of \>21 mm Hg in the study eye 3. Clinical or pathological evidence of giant cell arteritis 4. Diseases that may affect the optic nerve: glaucoma, multiple sclerosis, Alzheimer disease, and Parkinson disease. Evidence of optic disc drusen and optic nerve hypoplasia are not

Design outcomes

Primary

Measure	Time frame	Description
Anatomical characteristics on OCT	At enrollment	Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines.
Vascular characteristics on OCT-A	3-months follow-up visit	Transient versus persistent findings of ischemia, segmental location and extent of reduced vessel density. If ODD is present the vessel density will be compared to ODD location and volume.

Secondary

Measure	Time frame	Description
Best corrected visual acuity	At enrollment	Assessed on Snellen or ETDRS chart
ODD characteristics	At 3-months follow-up visit	If ODD is present the volume and location of the ODD (superficial vs. deep) is measured using 3D-segmentation
Visual field test	At enrollment	Autoperimetry: SITA fast or standard 24-2
Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score	At enrollment	Score on questionnaire: National Eye Institute Visual Function Questionnaire 25 and 10-item Neuro-Ophthalmic Supplement A vision-targeted composite score of the NEI-VFQ-25 together with the 10-item NO supplement score is calculated. The scale is 0-100 where a high score represents better functioning.
Prevalence of comorbidities	At enrollment	ischemic heart disease, stroke (ischemic or hemorrhagic), arterial hypertension, diabetes mellitus, end stage renal disease, smoking (now or previous), dyslipidemia, obstructive sleep apnea/continuous positive airway pressure (CPAP) use, phosphodiesterase-5 inhibitor use or ocular surgery.

Other

Measure	Time frame	Description
Eye biometry: Keratometry	At enrollment	The curvature of the cornea in diopters
Eye biometry: Axial length	At enrollment	axial length of the eye in mm
Eye refraction in diopters	At enrollment	Spherical and cylindrical refraction. Measurements in diopters.
Color vision test score as fraction	At enrollment	Assessed on Ishihara or Hardy-Rand-Rittler plates. Measured as the fraction of how many correct plates out how many plates are used in the assessment in total. A score of 0 means no plates were read correctly and 1 means all plates were read correctly.

Countries

Australia, Canada, Denmark, France, Iran, Israel, New Zealand, United Kingdom, United States

Outcome results