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NA-AION Risk Factors: New Perspectives (NARROW)

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ClinicalTrials.gov Identifier: NCT05305079
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : March 31, 2022
Sponsor:
Collaborators:
Velux Fonden
Fight for Sight
Synoptik-Fonden
University of Copenhagen
Hamilton Health Sciences Corporation
Aarhus University Hospital
Aalborg University Hospital
Zealand University Hospital
Odense University Hospital
Farabi Eye Hospital
Wellington Hospital
University of Colorado, Denver
University of Utah
Lawson Health Research Institute
University of Sydney
Stanford University
Moorfields Eye Hospital NHS Foundation Trust
King's College Hospital NHS Trust
University of Calgary
Massachusetts Eye and Ear Infirmary
University of California, San Francisco
Stony Brook University
Sheba Medical Center
University Hospital, Bordeaux
Information provided by (Responsible Party):
Steffen Hamann, Rigshospitalet, Denmark

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.

Condition or disease
Non-arteritic Ischemic Optic Neuropathy Optic Disk Drusen

Detailed 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).

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Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Anatomical characteristics on OCT [ Time Frame: At enrollment ]
    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.

  2. Anatomical characteristics on OCT [ Time Frame: 3-months follow-up visit ]
    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. Vascular characteristics on OCT-A [ Time Frame: 3-months follow-up visit ]
    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.


Secondary Outcome Measures :
  1. ODD characteristics [ Time Frame: At 3-months follow-up visit ]
    If ODD is present the volume and location of the ODD (superficial vs. deep) is measured using 3D-segmentation

  2. Best corrected visual acuity [ Time Frame: At enrollment ]
    Assessed on Snellen or ETDRS chart

  3. Best corrected visual acuity [ Time Frame: 3-months follow-up visit ]
    Assessed on Snellen or ETDRS chart

  4. Visual field test [ Time Frame: At enrollment ]
    Autoperimetry: SITA fast or standard 24-2

  5. Visual field test [ Time Frame: 3-months follow-up visit ]
    Autoperimetry: SITA fast or standard 24-2

  6. Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score [ Time Frame: At enrollment ]

    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.


  7. Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score [ Time Frame: 3-months follow-up visit ]

    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.


  8. Prevalence of comorbidities [ Time Frame: At enrollment ]
    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.


Other Outcome Measures:
  1. Eye refraction in diopters [ Time Frame: At enrollment ]
    Spherical and cylindrical refraction. Measurements in diopters.

  2. Color vision test score as fraction [ Time Frame: At enrollment ]
    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. Color vision test score as fraction [ Time Frame: 3-months follow-up visit ]
    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.

  4. Eye biometry: Axial length [ Time Frame: At enrollment ]
    axial length of the eye in mm

  5. Eye biometry: Keratometry [ Time Frame: At enrollment ]
    The curvature of the cornea in diopters



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05305079


Contacts
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Contact: Lykkebirk +4540889817 lea.lykkebirk.01@regionh.dk
Contact: Hamann steffen.ellitsgaard.hamann@regionh.dk

Locations
Show Show 20 study locations
Sponsors and Collaborators
Rigshospitalet, Denmark
Velux Fonden
Fight for Sight
Synoptik-Fonden
University of Copenhagen
Hamilton Health Sciences Corporation
Aarhus University Hospital
Aalborg University Hospital
Zealand University Hospital
Odense University Hospital
Farabi Eye Hospital
Wellington Hospital
University of Colorado, Denver
University of Utah
Lawson Health Research Institute
University of Sydney
Stanford University
Moorfields Eye Hospital NHS Foundation Trust
King's College Hospital NHS Trust
University of Calgary
Massachusetts Eye and Ear Infirmary
University of California, San Francisco
Stony Brook University
Sheba Medical Center
University Hospital, Bordeaux
Investigators
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Principal Investigator: Steffen Hamann Rigshospitalet, Denmark
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Responsible Party: Steffen Hamann, MD, PhD, associate professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT05305079    
Other Study ID Numbers: H-20073063
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steffen Hamann, Rigshospitalet, Denmark:
Optical Coherence Tomography
Optical Coherence Tomography Angiography
Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Neuropathy, Ischemic
Optic Disk Drusen
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases