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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care | Experimental | 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 | Active Comparator | The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Best-Corrected Visual Acuity | 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Field Improvement | Humphrey Perimetry | Baseline to 1 week, 1, 3, 6, and 12 months postoperatively |
| Retinal Reperfusion Rate | fluorescein fundus angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Ma, MD. | Contact | +8618858299889 | jian_ma@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center of the Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310058 | China |
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| ID | Term |
|---|---|
| D015356 | Retinal Artery Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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| Standard Clinical Care Only | Procedure | The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis. |
|
| Baseline to 1 week, 1, 3, 6, and 12 months postoperatively |
| OCT/OCTA Structural-Perfusion Changes | Baseline to 1 week, 1, 3, 6, and 12 months postoperatively |
| D002318 |
| Cardiovascular Diseases |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |