Multicenter Retrospective Study on Low-Dose Intravenous Alteplase for Central Retinal Artery Occlusion

Multicenter Retrospective Study on Low-Dose Intravenous Alteplase for Central Retinal Artery Occlusion - Multicenter Retrospective Study on Low-Dose Intravenous Alteplase for Central Retinal Artery Occlusion

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056107

Enrollment

Registered

2024-12-01

Start date

2024-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-arteritic (NA) central retinal artery occlusion (CRAO, including branch retinal artery occlusion [BRAO] predicted to have a poor visual outcome)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. Patients diagnosed with NA-CRAO (or BRAO with a poor visual prognosis) by an ophthalmologist 3. Patients who presented within 24 hours of onset 4. Patients who presented between October 1, 2021 (or the date when the collaboration system between ophthalmologists and stroke physicians was established), and September 30, 2024

Exclusion criteria

Exclusion criteria: 1. Patients suspected of arteritic CRAO (or BRAO) 2. Patients who showed rapid visual improvement naturally (e.g., transient monocular blindness) 3. Patients with non-endogenous mechanisms of onset (e.g., related to ophthalmic or cosmetic surgery, trauma) 4. Patients who received urgent (within 48 hours of onset) endovascular treatment or carotid revascularization therapy 5. Cases where the patient or their legal representative expressed a desire not to participate 6. Patients deemed ineligible for enrollment by the study physician

Design outcomes

Primary

Measure	Time frame
Recovery to a corrected visual acuity of 20/100 or better in the affected eye within one month of onset (or, if pre-morbid visual acuity was below 20/100, an improvement of logMAR visual acuity by 0.3 or greater from onset or improvement to pre-morbid visual acuity)	—

Secondary

Measure	Time frame
Efficacy secondary outcomes Primary outcome measures for cases with initial visual acuity below 20/2000, below 20/200, and for CRAO cases For all enrolled cases and cases with initial visual acuity below 20/2000, below 20/200, and CRAO cases: degree of improvement in logMAR visual acuity from onset, improvement of logMAR visual acuity by 0.1 or greater, improvement of logMAR visual acuity by 0.3 or greater, and shift analysis Modified Rankin Scale (mRS) score at one month after onset Safety outcomes Serious bleeding events within 36 hours (symptomatic/any intracranial hemorrhage, intraocular hemorrhage, other bleeding), onset of cerebral infarction within one month, recurrence of CRAO/BRAO in the affected eye within one month, and mortality within one month	—

Measure

Time frame

Efficacy secondary outcomes Primary outcome measures for cases with initial visual acuity below 20/2000, below 20/200, and for CRAO cases For all enrolled cases and cases with initial visual acuity below 20/2000, below 20/200, and CRAO cases: degree of improvement in logMAR visual acuity from onset, improvement of logMAR visual acuity by 0.1 or greater, improvement of logMAR visual acuity by 0.3 or greater, and shift analysis Modified Rankin Scale (mRS) score at one month after onset Safety outcomes Serious bleeding events within 36 hours (symptomatic/any intracranial hemorrhage, intraocular hemorrhage, other bleeding), onset of cerebral infarction within one month, recurrence of CRAO/BRAO in the affected eye within one month, and mortality within one month

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Countries

Japan

Contacts

Public ContactMikito Hayakawa

University of Tsukuba Hospital Department of Stroke and Cerebrovascular Diseases

hayakawa.mikito@md.tsukuba.ac.jp0298533220

Outcome results