NCT05305079

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 Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
9 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 22, 2024

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

July 26, 2021

Last Update Submit

November 19, 2024

Conditions

Non-arteritic Ischemic Optic NeuropathyOptic Disk Drusen

Keywords

Optical Coherence TomographyOptical Coherence Tomography Angiography

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (8)

  • ODD characteristics

    At 3-months follow-up visit

  • Best corrected visual acuity

    At enrollment

  • Best corrected visual acuity

    3-months follow-up visit

  • Visual field test

    At enrollment

  • Visual field test

    3-months follow-up visit

  • +3 more secondary outcomes

Other Outcomes (5)

  • Eye refraction in diopters

    At enrollment

  • Color vision test score as fraction

    At enrollment

  • Color vision test score as fraction

    3-months follow-up visit

  • +2 more other outcomes

Study Arms (2)

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.

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period.

You may qualify if:

  • Diagnosis of first episode of NA-AION in study eye with symptom onset within 1 month prior
  • Subject age: Age \>10
  • 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 deviation worse than 3.0 dB using the study visual field examination protocol

You may not qualify if:

  • Previous episode of NA-AION in the study eye only
  • Intraocular pressure of \>21 mm Hg in the study eye
  • Clinical or pathological evidence of giant cell arteritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Stanford Medicine

Palo Alto, California, 94305, United States

Location

UCSF Medical Center

San Francisco, California, 94143, United States

Location

University og Colorado

Boulder, Colorado, 80309, United States

Location

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location

John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

Sydney Eye Hospital

Sydney, Australia

Location

University of Calgary

Calgary, Canada

Location

Research St. Joseph's

Hamilton, Canada

Location

Lawson Health Research Institute

London, Canada

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Zealand University Hospital

Roskilde, Denmark

Location

Bordeaux University Hospital

Bordeaux, France

Location

Farabi Eye Hospital

Tehran, Iran

Location

Sheba Medical Center

Tel Aviv, Israel

Location

Capital and Coast DHB

Wellington, New Zealand

Location

University of Cambridge

Cambridge, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Moorfield's Eye Hospital

London, United Kingdom

Location

Related Publications (1)

  • Klefter ON, Hansen MS, Lykkebirk L, Subhi Y, Brittain JM, Jensen MR, Dohn UM, Fana V, Wiencke AK, Heegaard S, Terslev L, Hamann S. Combining Paracentral Acute Middle Maculopathy and Peripapillary Fluid as Biomarkers in Anterior Ischemic Optic Neuropathy. Am J Ophthalmol. 2025 Mar;271:329-336. doi: 10.1016/j.ajo.2024.12.001. Epub 2024 Dec 6.

    PMID: 39645178DERIVED

MeSH Terms

Conditions

Optic Disk Drusen

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Steffen Hamann

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, associate professor

Study Record Dates

First Submitted

July 26, 2021

First Posted

March 31, 2022

Study Start

August 1, 2021

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

November 22, 2024

Record last verified: 2022-03

Locations

US(5)CA(3)FR(1)IL(1)DK(4)IR(1)NZ(1)GB(3)AU(1)