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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives
Secondary ID [1] 0 0
H-20073063
Universal Trial Number (UTN)
Trial acronym
NARROW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-arteritic Ischemic Optic Neuropathy 0 0
Optic Disk Drusen 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anatomical characteristics on OCT
Timepoint [1] 0 0
At enrollment
Primary outcome [2] 0 0
Anatomical characteristics on OCT
Timepoint [2] 0 0
3-months follow-up visit
Primary outcome [3] 0 0
Vascular characteristics on OCT-A
Timepoint [3] 0 0
3-months follow-up visit
Secondary outcome [1] 0 0
ODD characteristics
Timepoint [1] 0 0
At 3-months follow-up visit
Secondary outcome [2] 0 0
Best corrected visual acuity
Timepoint [2] 0 0
At enrollment
Secondary outcome [3] 0 0
Best corrected visual acuity
Timepoint [3] 0 0
3-months follow-up visit
Secondary outcome [4] 0 0
Visual field test
Timepoint [4] 0 0
At enrollment
Secondary outcome [5] 0 0
Visual field test
Timepoint [5] 0 0
3-months follow-up visit
Secondary outcome [6] 0 0
Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
Timepoint [6] 0 0
At enrollment
Secondary outcome [7] 0 0
Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
Timepoint [7] 0 0
3-months follow-up visit
Secondary outcome [8] 0 0
Prevalence of comorbidities
Timepoint [8] 0 0
At enrollment

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)
Minimum age
11 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
Canada
State/province [5] 0 0
Calgary
Country [6] 0 0
Canada
State/province [6] 0 0
Hamilton
Country [7] 0 0
Canada
State/province [7] 0 0
London
Country [8] 0 0
Denmark
State/province [8] 0 0
Aalborg
Country [9] 0 0
Denmark
State/province [9] 0 0
Aarhus
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense
Country [11] 0 0
Denmark
State/province [11] 0 0
Roskilde
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
Iran, Islamic Republic of
State/province [13] 0 0
Teheran
Country [14] 0 0
Israel
State/province [14] 0 0
Tel Aviv
Country [15] 0 0
New Zealand
State/province [15] 0 0
Wellington
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Cambridge
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Rigshospitalet, Denmark
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Velux Fonden
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Fight for Sight
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Synoptik-Fonden
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Copenhagen
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Hamilton Health Sciences Corporation
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Aarhus University Hospital
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Aalborg University Hospital
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Zealand University Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Odense University Hospital
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Farabi Eye Hospital
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Wellington Hospital
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
University of Colorado, Denver
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
University of Utah
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Lawson Health Research Institute
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
University of Sydney
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Stanford University
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
Moorfields Eye Hospital NHS Foundation Trust
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
King's College Hospital NHS Trust
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
University of Calgary
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Other
Name [20] 0 0
Massachusetts Eye and Ear Infirmary
Address [20] 0 0
Country [20] 0 0
Other collaborator category [21] 0 0
Other
Name [21] 0 0
University of California, San Francisco
Address [21] 0 0
Country [21] 0 0
Other collaborator category [22] 0 0
Other
Name [22] 0 0
Stony Brook University
Address [22] 0 0
Country [22] 0 0
Other collaborator category [23] 0 0
Other
Name [23] 0 0
Sheba Medical Center
Address [23] 0 0
Country [23] 0 0
Other collaborator category [24] 0 0
Other
Name [24] 0 0
University Hospital, Bordeaux
Address [24] 0 0
Country [24] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05305079
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steffen Hamann
Address 0 0
Rigshospitalet, Denmark
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lykkebirk
Address 0 0
Country 0 0
Phone 0 0
+4540889817
Fax 0 0
Email 0 0
lea.lykkebirk.01@regionh.dk
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05305079