Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Standard Clinical Care Only: The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis.

Study 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.

Eligibility

Primary outcome measure(s)

• Best-Corrected Visual Acuity — 1 month postoperatively

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China