Long-term Clinical Outcomes After Retinal Artery Occlusion (CVO-RAO)

Long-Term Cardiovascular and Cerebrovascular Outcomes After Retinal Artery Occlusion: A Nationwide Study

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.

Study Overview

• Status: Recruiting
• Conditions: Retinal Artery Occlusion
• Intervention / Treatment: Other: retinal artery occlusion

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.

• Study Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Seung Hun Lee, MD, PhD; Phone Number: 82-62-220-6246; Email: lsh8602@naver.com

Study Locations

• South Korea
  • Gwangju
    • Gwangju, Gwangju, South Korea, 61469
      • Recruiting
      • Chonnam National University Hospital
      • Principal Investigator: Seung Hun Lee, MD, PhD
      • Contact: Seung Hun Lee, MD, PhD; Phone Number: 82-62-220-6246; Email: lsh8602@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who underwent retinal artery occlusion; Among the total cohort, patients who underwent retinal artery occlusion were selected.	Other: retinal artery occlusion; treatment for 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
Occurrence of myocardial infarction	Myocarrdial infarction	up to 5 years
Occurrence of revascularization	Percutaneous coronary intervention or coronary artery bypass grafting	up to 5 years
Occurrence of stroke	Ischemic or hemorrhagic stroke	up to 5 years
Occurrence of admission due to heart failure	Hospital admission due to heart failure	up to 5 years
Occurrence of atrial fibrillation	Newly developed atrial fibrillation	up to 5 years
Occurrence of major and clinically relevant non-major bleeding	Major and clinically relevant non-major bleeding	up to 5 years

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Investigators: Principal Investigator: Seung Hun Lee, MD, PhD, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: RAO; CRAO; BRAO
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Arterial Occlusive Diseases; Retinal Diseases; Retinal Artery Occlusion
• Other Study ID Numbers: CNUH-EXP-2026-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No