Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
179 participants
OBSERVATIONAL
2021-08-01
2024-08-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ODD-AION
NA-AION patients with ODD aka. Optic disc drusen associated non-arteritic anterior ischemic optic neuropathy.
No interventions assigned to this group
nODD-AION
NA-AION patients without ODD aka Non-optic disc drusen associated non-arteritic anterior ischemic optic neuropathy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. Intraocular pressure of \>21 mm Hg in the study eye
3. Clinical or pathological evidence of giant cell arteritis
11 Years
ALL
No
Sponsors
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Velux Fonden
OTHER
Fight for Sight
OTHER
University of Copenhagen
OTHER
Hamilton Health Sciences Corporation
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Odense University Hospital
OTHER
Farabi Eye Hospital
OTHER
Wellington Hospital
OTHER_GOV
University of Colorado, Denver
OTHER
University of Utah
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
University of Sydney
OTHER
Stanford University
OTHER
Moorfields Eye Hospital NHS Foundation Trust
OTHER
Massachusetts Eye and Ear Infirmary
OTHER
University Hospital, Bordeaux
OTHER
Synoptik-Fonden
UNKNOWN
Rigshospitalet, Denmark
OTHER
Responsible Party
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Steffen Hamann
MD, PhD, associate professor
Principal Investigators
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Steffen Hamann
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Stanford Medicine
Palo Alto, California, United States
UCSF Medical Center
San Francisco, California, United States
University og Colorado
Boulder, Colorado, United States
Massachusetts Eye and Ear
Boston, Massachusetts, United States
John A. Moran Eye Center
Salt Lake City, Utah, United States
Sydney Eye Hospital
Sydney, , Australia
University of Calgary
Calgary, , Canada
Research St. Joseph's
Hamilton, , Canada
Lawson Health Research Institute
London, , Canada
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Odense University Hospital
Odense, , Denmark
Zealand University Hospital
Roskilde, , Denmark
Bordeaux University Hospital
Bordeaux, , France
Farabi Eye Hospital
Tehran, , Iran
Sheba Medical Center
Tel Aviv, , Israel
Capital and Coast DHB
Wellington, , New Zealand
University of Cambridge
Cambridge, , United Kingdom
King's College Hospital
London, , United Kingdom
Moorfield's Eye Hospital
London, , United Kingdom
Countries
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References
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Klefter ON, Hansen MS, Lykkebirk L, Subhi Y, Brittain JM, Jensen MR, Dohn UM, Fana V, Wiencke AK, Heegaard S, Terslev L, Hamann S. Combining Paracentral Acute Middle Maculopathy and Peripapillary Fluid as Biomarkers in Anterior Ischemic Optic Neuropathy. Am J Ophthalmol. 2025 Mar;271:329-336. doi: 10.1016/j.ajo.2024.12.001. Epub 2024 Dec 6.
Other Identifiers
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H-20073063
Identifier Type: -
Identifier Source: org_study_id
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