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| Name | Class |
|---|---|
| Velux Fonden | OTHER |
| Fight for Sight | OTHER |
| University of Copenhagen | OTHER |
| Hamilton Health Sciences Corporation |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ODD-AION | NA-AION patients with ODD aka. Optic disc drusen associated non-arteritic anterior ischemic optic neuropathy. | ||
| nODD-AION | NA-AION patients without ODD aka Non-optic disc drusen associated non-arteritic anterior ischemic optic neuropathy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Anatomical characteristics on OCT | 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. | At enrollment |
| Anatomical characteristics on OCT | 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-months follow-up visit |
| Vascular characteristics on OCT-A | 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. | 3-months follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| ODD characteristics | If ODD is present the volume and location of the ODD (superficial vs. deep) is measured using 3D-segmentation | At 3-months follow-up visit |
| Best corrected visual acuity | Assessed on Snellen or ETDRS chart |
| Measure | Description | Time Frame |
|---|---|---|
| Eye refraction in diopters | Spherical and cylindrical refraction. Measurements in diopters. | At enrollment |
| Color vision test score as fraction | 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. |
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:
Exclusion Criteria:
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The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period.
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| Name | Affiliation | Role |
|---|---|---|
| Steffen Hamann | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medicine | Palo Alto | California | 94305 | United States | ||
| UCSF Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39645178 | Derived | 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. |
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| 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 |
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| At enrollment |
| Best corrected visual acuity | Assessed on Snellen or ETDRS chart | 3-months follow-up visit |
| Visual field test | Autoperimetry: SITA fast or standard 24-2 | At enrollment |
| Visual field test | Autoperimetry: SITA fast or standard 24-2 | 3-months follow-up visit |
| Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score | 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. | At enrollment |
| Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score | 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. | 3-months follow-up visit |
| Prevalence of comorbidities | 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. | At enrollment |
| At enrollment |
| Color vision test score as fraction | 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-months follow-up visit |
| Eye biometry: Axial length | axial length of the eye in mm | At enrollment |
| Eye biometry: Keratometry | The curvature of the cornea in diopters | At enrollment |
| San Francisco |
| California |
| 94143 |
| United States |
| University og Colorado | Boulder | Colorado | 80309 | United States |
| Massachusetts Eye and Ear | Boston | Massachusetts | 02114 | United States |
| John A. Moran Eye Center | Salt Lake City | Utah | 84132 | 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 |
| ID | Term |
|---|---|
| D015594 | Optic Disk Drusen |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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