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: 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).
Study Type
OBSERVATIONAL
Enrollment
179
Stanford Medicine
Palo Alto, California, United States
UCSF Medical Center
San Francisco, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 3-months follow-up visit
ODD characteristics
If ODD is present the volume and location of the ODD (superficial vs. deep) is measured using 3D-segmentation
Time frame: At 3-months follow-up visit
Best corrected visual acuity
Assessed on Snellen or ETDRS chart
Time frame: At enrollment
Best corrected visual acuity
Assessed on Snellen or ETDRS chart
Time frame: 3-months follow-up visit
Visual field test
Autoperimetry: SITA fast or standard 24-2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 10 more locations
Time frame: At enrollment
Visual field test
Autoperimetry: SITA fast or standard 24-2
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At enrollment