Long-term Clinical Outcomes After Retinal Artery Occlusion | NCT07482228

Studies
Long-term Clinical Outcomes After Retinal Artery Occlusion

NCT07482228

Sponsor

Chonnam National University Hospital

Status

Recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Retinal Artery Occlusion

Interventions

retinal artery occlusion

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2026Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Aug 31, 2027Estimated

First Submitted Date

Mar 16, 2026

First Submission Date that Met QC Criteria

Mar 16, 2026

First Posted Date

Mar 19, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 19, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seung Hun Lee, Associate Professor, Chonnam National University HospitalPrincipal Investigator

Lead Sponsor

Chonnam National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retinal artery occlusion (RAO) is a rare but vision-threatening vascular disorder that is commonly caused by embolic events originating from the heart or carotid arteries. Patients with RAO are known to have an increased risk of subsequent cardiovascular and cerebrovascular events, including ischemic stroke and myocardial infarction. However, long-term outcomes and optimal medical treatment strategies for these patients remain insufficiently characterized.

The purpose of this nationwide population-based study is to investigate the incidence of long-term cardiovascular and cerebrovascular outcomes in patients diagnosed with retinal artery occlusion using the Korean National Health Insurance Service (NHIS) database. In addition, the study aims to evaluate the impact of various medical therapies, including antiplatelet agents, anticoagulants, and statins, on long-term clinical outcomes.

Detailed Description

Retinal artery occlusion (RAO) is an acute retinal vascular disease that results in sudden and severe vision loss. RAO is typically classified into central retinal artery occlusion (CRAO) and branch retinal artery occlusion (BRAO), depending on the site of arterial obstruction. CRAO generally has a worse clinical prognosis compared with BRAO.

Previous studies have demonstrated that RAO is associated with systemic vascular diseases and an increased risk of ischemic stroke and other cardiovascular events. Despite its clinical significance, effective evidence-based treatment strategies for RAO remain unclear.

This study aims to evaluate the epidemiology and long-term cardiovascular outcomes of patients with RAO in Korea using the National Health Insurance Service (NHIS) database, which covers nearly the entire Korean population. Patients newly diagnosed with RAO between January 2010 and December 2024 will be identified.

This nationwide population-based study may help clarify the long-term prognosis of RAO and identify optimal medical treatment strategies for improving clinical outcomes in these patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients who underwent retinal artery occlusion		Among the total cohort, patients who underwent retinal artery occlusion were selected.	Other: retinal artery occlusion
Matched cohort		Among the total cohort, 1:6 age- and sex-matched subjects without retinal artery occlusion using a propensity score were generated.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
retinal artery occlusion	Other	treatment for retinal artery occlusion	Patients who underwent retinal artery occlusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of MACCE	major adverse cardiovascular and cerebrovascular event	up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of all-cause death	Death from any causes	up to 5 years
Occurrence of cardiac death	Death from cardiac causes	up to 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients newly diagnosed with retinal artery occlusion

Exclusion Criteria:

Patients with a prior diagnosis of retinal artery occlusion before the study period.
Patients diagnosed with giant cell arteritis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients newly diagnosed with retinal artery occlusion (RAO) between 2010 and 2024 identified from the Korean National Health Insurance Service (NHIS) database.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seung Hun Lee, MD, PhD	Contact	82-62-220-6246		lsh8602@naver.com

Overall Officials

Name	Affiliation	Role
Seung Hun Lee, MD, PhD	Chonnam National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonnam National University Hospital	Recruiting	Gwangju	Gwangju	61469	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015356	Retinal Artery Occlusion

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided