NA-AION Risk Factors: New Perspectives

Non-arteritic Ischemic Optic Neuropathy Clinical Trial

— NARROW  

Official title:

Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305079
• Other study ID #: H-20073063
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2022
• Source: Rigshospitalet, Denmark
• Contact: Lykkebirk
• Phone: +4540889817
• Email: lea.lykkebirk.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: August 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years and older

Eligibility

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)

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.

Related Conditions & MeSH terms

• Non-arteritic Ischemic Optic Neuropathy
• Optic Disk Drusen
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Locations

Country	Name	City	State
Australia	Sydney Eye Hospital	Sydney
Canada	University of Calgary	Calgary
Canada	Research St. Joseph's	Hamilton
Canada	Lawson Health Research Institute	London
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Odense University Hospital	Odense
Denmark	Zealand University Hospital	Roskilde
France	Bordeaux University Hospital	Bordeaux
Iran, Islamic Republic of	Farabi Eye Hospital	Teheran
Israel	Sheba Medical Center	Tel Aviv
New Zealand	Capital and Coast DHB	Wellington
United Kingdom	University of Cambridge	Cambridge
United Kingdom	King's College Hospital	London
United Kingdom	Moorfield's Eye Hospital	London
United States	Massachusetts Eye and Ear	Boston	Massachusetts
United States	University og Colorado	Boulder	Colorado
United States	Stanford Medicine	Palo Alto	California
United States	John A. Moran Eye Center	Salt Lake City	Utah
United States	UCSF Medical Center	San Francisco	California

Sponsors (25)

Lead Sponsor

Collaborator

Rigshospitalet, Denmark

Aalborg University Hospital, Aarhus University Hospital, Farabi Eye Hospital, Fight for Sight, Hamilton Health Sciences Corporation, King's College Hospital NHS Trust, Lawson Health Research Institute, Massachusetts Eye and Ear Infirmary, Moorfields Eye Hospital NHS Foundation Trust, Odense University Hospital, Sheba Medical Center, Stanford University, Stony Brook University, Synoptik-Fonden, University Hospital, Bordeaux, University of Calgary, University of California, San Francisco, University of Colorado, Denver, University of Copenhagen, University of Sydney, University of Utah, Velux Fonden, Wellington Hospital, Zealand University Hospital

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  France,  Iran, Islamic Republic of,  Israel,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eye refraction in diopters	Spherical and cylindrical refraction. Measurements in diopters.	At enrollment
Other	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.	At enrollment
Other	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
Other	Eye biometry: Axial length	axial length of the eye in mm	At enrollment
Other	Eye biometry: Keratometry	The curvature of the cornea in diopters	At enrollment
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Best corrected visual acuity	Assessed on Snellen or ETDRS chart	At enrollment
Secondary	Best corrected visual acuity	Assessed on Snellen or ETDRS chart	3-months follow-up visit
Secondary	Visual field test	Autoperimetry: SITA fast or standard 24-2	At enrollment
Secondary	Visual field test	Autoperimetry: SITA fast or standard 24-2	3-months follow-up visit
Secondary	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
Secondary	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
Secondary	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