Central Retinal Artery Occlusion
Conditions
Keywords
central retinal artery occlusion, microneedle, thrombolysis
Brief summary
This prospective interventional study evaluates the efficacy and safety of direct intra-arterial microneedle injection combined with pars plana vitrectomy for acute retinal artery occlusion (including central retinal artery occlusion \[CRAO\] and branch retinal artery occlusion \[BRAO\] involving the macula or causing severe visual loss). The primary endpoint is best-corrected visual acuity (BCVA, LogMAR) at 1 month. Secondary objectives include assessing the effect of treatment timing and monitoring longitudinal changes in visual function and retinal structure over 12 months.
Detailed description
Retinal artery occlusion lacks an established standard therapy. This prospective, non-randomized, parallel-group interventional trial compares pars plana vitrectomy with direct intra-arterial microneedle thrombolysis plus standard care (experimental arm) with standard clinical care alone (control arm). The trial is open-label, and outcome assessors for BCVA, automated perimetry, fluorescein angiography (FFA), and optical coherence tomography (OCT) will be masked. Scheduled visits occur at 1 week, 1 month, 3 months, 6 months, and 12 months. The symptom-to-treatment interval (≤3 days vs 3-7 days) is a prespecified subgroup for secondary analyses.
Interventions
PROCEDUREVitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care
The patients will receive standard pars plana vitrectomy (PPV) combined with direct intra-arterial microneedle thrombolysis under microscopic visualization, in addition to standard clinical treatment for RAO. A 47G microneedle will be used to deliver thrombolytic agent intra-arterially per protocol.
PROCEDUREStandard Clinical Care Only
The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Acute non-arteritic retinal artery occlusion (RAO), including: Central retinal artery occlusion (CRAO), or Branch retinal artery occlusion (BRAO) involving the macula or causing severe visual loss; defined as symptom onset ≤7 days and confirmed by exam ± imaging (FFA/OCT) * Best-corrected visual acuity (BCVA) \<0.5 (decimal)
Exclusion criteria
* Active bleeding disorder, or significant bleeding within the past 3 months, or bleeding diathesis * Severe hypertension: SBP \>185 mmHg or DBP \>110 mmHg * Severe coagulopathy or ongoing therapeutic anticoagulation * Ischemic stroke within the past 3 months * Severe, unstable systemic disease rendering surgery or anesthesia risk unacceptable * Known hypersensitivity to thrombolytic agents or any study medications/materials * Active ocular infection * Vitreous hemorrhage * Retinal arteritis * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-Corrected Visual Acuity | 1 month postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Field Improvement | Baseline to 1 week, 1, 3, 6, and 12 months postoperatively | Humphrey Perimetry |
| Retinal Reperfusion Rate | Baseline to 1 week, 1, 3, 6, and 12 months postoperatively | fluorescein fundus angiography |
| OCT/OCTA Structural-Perfusion Changes | Baseline to 1 week, 1, 3, 6, and 12 months postoperatively | — |
Countries
China
Contacts
Primary ContactJian Ma, MD.
Outcome results
None listed