Microneedle Intra-Arterial Injection for Retinal Artery Occlusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care, Standard Clinical Care Only.
- Who it may be relevant to
- Registry conditions: Central Retinal Artery Occlusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Microneedle Intra-Arterial Injection With Pars Plana Vitrectomy for Acute Retinal Artery Occlusion: A Prospective Clinical Trial
Overview
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
- Procedure Vitrectomy + 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. - Procedure Standard Clinical Care Only
The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis.
Primary outcome measures
- Best-Corrected Visual Acuity [Time frame: 1 month postoperatively]
Secondary outcome measures (3)
- Visual Field Improvement [Time frame: Baseline to 1 week, 1, 3, 6, and 12 months postoperatively]
- Retinal Reperfusion Rate [Time frame: Baseline to 1 week, 1, 3, 6, and 12 months postoperatively]
- OCT/OCTA Structural-Perfusion Changes [Time frame: Baseline to 1 week, 1, 3, 6, and 12 months postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Eye Center of the Second Affiliated Hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT07151755 · 20251159