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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05305079
Registration number
NCT05305079
Ethics application status
Date submitted
26/07/2021
Date registered
31/03/2022
Date last updated
31/03/2022
Titles & IDs
Public title
NA-AION Risk Factors: New Perspectives
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Scientific title
Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives
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Secondary ID [1]
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H-20073063
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Universal Trial Number (UTN)
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Trial acronym
NARROW
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-arteritic Ischemic Optic Neuropathy
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Optic Disk Drusen
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Neurological
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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Anatomical characteristics on OCT
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Assessment method [1]
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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.
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Timepoint [1]
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At enrollment
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Primary outcome [2]
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Anatomical characteristics on OCT
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Assessment method [2]
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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.
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Timepoint [2]
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3-months follow-up visit
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Primary outcome [3]
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Vascular characteristics on OCT-A
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Assessment method [3]
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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.
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Timepoint [3]
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3-months follow-up visit
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Secondary outcome [1]
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ODD characteristics
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Assessment method [1]
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If ODD is present the volume and location of the ODD (superficial vs. deep) is measured using 3D-segmentation
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Timepoint [1]
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At 3-months follow-up visit
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Secondary outcome [2]
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Best corrected visual acuity
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Assessment method [2]
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Assessed on Snellen or ETDRS chart
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Timepoint [2]
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At enrollment
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Secondary outcome [3]
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Best corrected visual acuity
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Assessment method [3]
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Assessed on Snellen or ETDRS chart
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Timepoint [3]
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3-months follow-up visit
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Secondary outcome [4]
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Visual field test
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Assessment method [4]
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Autoperimetry: SITA fast or standard 24-2
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Timepoint [4]
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At enrollment
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Secondary outcome [5]
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Visual field test
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Assessment method [5]
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Autoperimetry: SITA fast or standard 24-2
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Timepoint [5]
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3-months follow-up visit
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Secondary outcome [6]
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Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
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Assessment method [6]
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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.
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Timepoint [6]
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At enrollment
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Secondary outcome [7]
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Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
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Assessment method [7]
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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.
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Timepoint [7]
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3-months follow-up visit
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Secondary outcome [8]
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Prevalence of comorbidities
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Assessment method [8]
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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.
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Timepoint [8]
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At enrollment
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Eligibility
Key inclusion criteria
1. Diagnosis of first episode of NA-AION in study eye with symptom onset within 14 days prior
2. Subject age: Age >10
3. NA-AION diagnosis requires:
* disc edema seen and documented by site PI
* 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)
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Minimum age
11
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2023
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Actual
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Sample size
Target
650
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sydney Eye Hospital - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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Utah
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Country [5]
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Canada
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State/province [5]
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Calgary
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Country [6]
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Canada
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State/province [6]
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Hamilton
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Country [7]
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Canada
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State/province [7]
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London
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Country [8]
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Denmark
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State/province [8]
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Aalborg
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Country [9]
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Denmark
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State/province [9]
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Aarhus
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Country [10]
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Denmark
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State/province [10]
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Odense
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Country [11]
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Denmark
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State/province [11]
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Roskilde
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Country [12]
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France
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State/province [12]
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Bordeaux
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Country [13]
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Iran, Islamic Republic of
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State/province [13]
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Teheran
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Country [14]
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Israel
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State/province [14]
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Tel Aviv
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Country [15]
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New Zealand
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State/province [15]
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Wellington
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Country [16]
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United Kingdom
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State/province [16]
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Cambridge
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Country [17]
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United Kingdom
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State/province [17]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Rigshospitalet, Denmark
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Velux Fonden
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Fight for Sight
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Synoptik-Fonden
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Copenhagen
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Hamilton Health Sciences Corporation
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Aarhus University Hospital
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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Aalborg University Hospital
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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Zealand University Hospital
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Address [8]
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Country [8]
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Other collaborator category [9]
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Other
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Name [9]
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Odense University Hospital
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Address [9]
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Country [9]
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Other collaborator category [10]
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Other
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Name [10]
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Farabi Eye Hospital
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Address [10]
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Country [10]
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Other collaborator category [11]
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Government body
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Name [11]
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Wellington Hospital
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Address [11]
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Country [11]
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Other collaborator category [12]
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Other
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Name [12]
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University of Colorado, Denver
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Address [12]
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Country [12]
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Other collaborator category [13]
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Other
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Name [13]
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University of Utah
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Address [13]
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Country [13]
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Other collaborator category [14]
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Other
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Name [14]
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Lawson Health Research Institute
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Address [14]
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Country [14]
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Other collaborator category [15]
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Other
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Name [15]
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University of Sydney
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Address [15]
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Country [15]
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Other collaborator category [16]
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Other
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Name [16]
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Stanford University
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Address [16]
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Country [16]
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Other collaborator category [17]
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Other
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Name [17]
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Moorfields Eye Hospital NHS Foundation Trust
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Address [17]
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Other collaborator category [18]
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Other
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Name [18]
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King's College Hospital NHS Trust
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Address [18]
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Other collaborator category [19]
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Other
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Name [19]
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University of Calgary
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Address [19]
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Other collaborator category [20]
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Other
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Name [20]
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Massachusetts Eye and Ear Infirmary
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Address [20]
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Other collaborator category [21]
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Other
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Name [21]
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University of California, San Francisco
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Address [21]
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Other collaborator category [22]
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Other
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Name [22]
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Stony Brook University
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Address [22]
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Country [22]
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Other collaborator category [23]
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Government body
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Name [23]
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Sheba Medical Center
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Address [23]
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Country [23]
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Other collaborator category [24]
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Other
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Name [24]
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University Hospital, Bordeaux
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Address [24]
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Country [24]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05305079
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Steffen Hamann
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Address
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Rigshospitalet, Denmark
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lykkebirk
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Address
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Country
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Phone
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+4540889817
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05305079
Download to PDF