Clinical trial NCT05305079: NA-AION Risk Factors: New Perspectives
Official title: Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-arteritic Ischemic Optic Neuropathy
Optic Disk Drusen
Keywords: Optical Coherence Tomography
Optical Coherence Tomography Angiography
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: Fight for Sight
name: University of Copenhagen
name: Hamilton Health Sciences Corporation
name: Aarhus University Hospital
name: Aalborg University Hospital
name: Odense University Hospital
name: Farabi Eye Hospital
name: Wellington Hospital
name: University of Colorado, Denver
name: University of Utah
name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: University of Sydney
name: Stanford University
name: Moorfields Eye Hospital NHS Foundation Trust
name: Massachusetts Eye and Ear Infirmary
name: University Hospital, Bordeaux
name: Synoptik-Fonden
First posted: 2022-03-31
Enrollment: 179
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period.

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).

Eligibility criteria: 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 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.

Primary outcomes:
measure: Anatomical characteristics on OCT
timeFrame: At enrollment
measure: Anatomical characteristics on OCT
timeFrame: 3-months follow-up visit
measure: Vascular characteristics on OCT-A
timeFrame: 3-months follow-up visit
Secondary outcomes:
measure: ODD characteristics
timeFrame: At 3-months follow-up visit
measure: Best corrected visual acuity
timeFrame: At enrollment
measure: Best corrected visual acuity
timeFrame: 3-months follow-up visit
measure: Visual field test
timeFrame: At enrollment
measure: Visual field test
timeFrame: 3-months follow-up visit
measure: Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
timeFrame: At enrollment
measure: Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
timeFrame: 3-months follow-up visit
measure: Prevalence of comorbidities
timeFrame: At enrollment
Other outcomes:
measure: Eye refraction in diopters
timeFrame: At enrollment
measure: Color vision test score as fraction
timeFrame: At enrollment
measure: Color vision test score as fraction
timeFrame: 3-months follow-up visit
measure: Eye biometry: Axial length
timeFrame: At enrollment
measure: Eye biometry: Keratometry
timeFrame: At enrollment
Locations:
city: Palo Alto
country: United States
facility: Stanford Medicine
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Boulder
country: United States
facility: University og Colorado
state: Colorado
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Salt Lake City
country: United States
facility: John A. Moran Eye Center
state: Utah
city: Sydney
country: Australia
facility: Sydney Eye Hospital
city: Calgary
country: Canada
facility: University of Calgary
city: Hamilton
country: Canada
facility: Research St. Joseph's
city: London
country: Canada
facility: Lawson Health Research Institute
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Teheran
country: Iran, Islamic Republic of
facility: Farabi Eye Hospital
city: Tel Aviv
country: Israel
facility: Sheba Medical Center
city: Wellington
country: New Zealand
facility: Capital and Coast DHB
city: Cambridge
country: United Kingdom
facility: University of Cambridge
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Moorfield's Eye Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Steffen Hamann
role: PRINCIPAL_INVESTIGATOR
References: