NA-AION Risk Factors: New Perspectives

Last updated: November 19, 2024
Sponsor: Rigshospitalet, Denmark
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05305079
H-20073063
  • Ages > 11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of first episode of NA-AION in study eye with symptom onset within 1 monthprior

  2. Subject age: Age >10

  3. NA-AION diagnosis requires:

  • disc edema seen by site PI or by referring doctor

  • visual field defect in the study eye consistent with NA-AION and mean deviationworse than 3.0 dB using the study visual field examination protocol

  • relative afferent pupillary defect (unless the fellow eye had previous NA-AIONor other optic nerve or retinal disease that is not exclusionary)

Exclusion

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, Alzheimerdisease, and Parkinson disease. Evidence of optic disc drusen and optic nervehypoplasia are not exclusion criteria given they are important parts of the study.We will not exclude significant retinal diseases, since they may be related tounderlying etiologies giving rise to ODD, such as macular degeneration, retinaldystrophies, but eyes with significant retinal diseases will be analyzed separately.

Study Design

Total Participants: 179
Study Start date:
August 01, 2021
Estimated Completion Date:
August 31, 2024

Study 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).

Connect with a study center

  • Sydney Eye Hospital

    Sydney,
    Australia

    Site Not Available

  • University of Calgary

    Calgary,
    Canada

    Site Not Available

  • Research St. Joseph's

    Hamilton,
    Canada

    Site Not Available

  • Lawson Health Research Institute

    London,
    Canada

    Site Not Available

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense,
    Denmark

    Site Not Available

  • Zealand University Hospital

    Roskilde,
    Denmark

    Site Not Available

  • Bordeaux University Hospital

    Bordeaux,
    France

    Site Not Available

  • Farabi Eye Hospital

    Teheran,
    Iran, Islamic Republic of

    Site Not Available

  • Sheba Medical Center

    Tel Aviv,
    Israel

    Site Not Available

  • Capital and Coast DHB

    Wellington,
    New Zealand

    Site Not Available

  • University of Cambridge

    Cambridge,
    United Kingdom

    Site Not Available

  • King's College Hospital

    London,
    United Kingdom

    Site Not Available

  • Moorfield's Eye Hospital

    London,
    United Kingdom

    Site Not Available

  • Stanford Medicine

    Palo Alto, California 94305
    United States

    Site Not Available

  • UCSF Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • University og Colorado

    Boulder, Colorado 80309
    United States

    Site Not Available

  • Massachusetts Eye and Ear

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • John A. Moran Eye Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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