Microneedle Intra-Arterial Injection With Pars Plana Vitrectomy for Acute Retinal Artery Occlusion: A Prospective Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
China
Eye Center of the Second Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Jian Ma, MD.
jian_ma@zju.edu.cn
+8618858299889
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 24
Treatments
Experimental: 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.
Active_comparator: Standard Clinical Care Only
The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials