Skip to main content
OpenTrials
Completed

NCT Number: NCT05305079

NA-AION Risk Factors: New Perspectives

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

11 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sydney Eye Hospital, Sydney, Australia

Loading trial locations.

About this study

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:

  • Characteristics of the optic nerve head anatomy including the presence of ODD as risk factors for the development of NA-AION.
  • 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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of first episode of NA-AION in study eye with symptom onset within 1 month prior
  • Subject age: Age >10
  • 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

  • Previous episode of NA-AION in the study eye only
  • Intraocular pressure of >21 mm Hg in the study eye
  • Clinical or pathological evidence of giant cell arteritis
  • 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 exclusion criteria given they are important parts of the study. We will not exclude significant retinal diseases, since they may be related to underlying etiologies giving rise to ODD, such as macular degeneration, retinal dystrophies, but eyes with significant retinal diseases will be analyzed separately.

Treatment and study plan

Primary outcomes

  1. Anatomical characteristics on OCT

    Time frame: 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.

  2. Anatomical characteristics on OCT

    Time frame: 3-months follow-up visit

    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.

  3. Vascular characteristics on OCT-A

    Time frame: 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 outcomes

  1. ODD characteristics

    Time frame: 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

  2. Best corrected visual acuity

    Time frame: At enrollment

    Assessed on Snellen or ETDRS chart

  3. Best corrected visual acuity

    Time frame: 3-months follow-up visit

    Assessed on Snellen or ETDRS chart

  4. Visual field test

    Time frame: At enrollment

    Autoperimetry: SITA fast or standard 24-2

  5. Visual field test

    Time frame: 3-months follow-up visit

    Autoperimetry: SITA fast or standard 24-2

  6. Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score

    Time frame: 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.

  7. Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score

    Time frame: 3-months follow-up visit

    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.

  8. Prevalence of comorbidities

    Time frame: 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 outcomes

  1. Eye refraction in diopters

    Time frame: At enrollment

    Spherical and cylindrical refraction. Measurements in diopters.

  2. Color vision test score as fraction

    Time frame: 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.

  3. Color vision test score as fraction

    Time frame: 3-months follow-up visit

    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.

  4. Eye biometry: Axial length

    Time frame: At enrollment

    axial length of the eye in mm

  5. Eye biometry: Keratometry

    Time frame: At enrollment

    The curvature of the cornea in diopters

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Farabi Eye Hospital
  • Fight for Sight
  • Hamilton Health Sciences Corporation
  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
  • Massachusetts Eye and Ear Infirmary
  • Moorfields Eye Hospital NHS Foundation Trust
  • Odense University Hospital
  • Stanford University
  • Synoptik-Fonden
  • University Hospital, Bordeaux
  • University of Colorado, Denver
  • University of Copenhagen
  • University of Sydney
  • University of Utah
  • Velux Fonden
  • Wellington Hospital

Registry information

Official study title

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

Acronym: NARROW

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Nov 22, 2024

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.

Published trials that share one or more normalized conditions with this study.