Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Central retinal artery occlusion (CRAO) is an ophthalmic emergency which leads to devastating visual function defects and poor prognosis. Though traditional conservative treatments are widely used, none of them is proved to be effective. A number of meta-analyses and observational studies indicate intravenous thrombolysis to be beneficial in CRAO. Selective intra-arterial thrombolysis (IAT) introducing rt-PA directly into the ophthalmic circulation by super-selective microcatheterization may reduce the complications such as intracranial and systemic hemorrhage.The residual visual field is significant for patients with CRAO who have poor central visual acuity. Thus, it is clinically significant to study the changes in visual fields in eyes with CRAO.
Central retinal artery occlusion (CRAO) is an ophthalmic emergency which leads to devastating visual function defects and poor prognosis. Though traditional conservative treatments are widely used, none of them is proved to be effective. The respective responses of brain and retinal tissues to acute ischemia share many features is the rationale for therapeutic thrombolysis in CRAO. Intravenous thrombolysis (IVT) has been a therapeutic choice for CRAO since the 1960s, and in the United States, tPA is currently administered in 5.8% of patients admitted with CRAO. A number of meta-analyses and observational studies indicate intravenous thrombolysis to be beneficial in CRAO. Selective intra-arterial thrombolysis (IAT) introducing rt-PA directly into the ophthalmic circulation by super-selective microcatheterization which has the advantage of reducing the dose of rt-PA reaching the systemic circulation. Thus, IAT may reduce the complications such as intracranial and systemic hemorrhage. The residual visual field is significant for patients with CRAO who have poor central visual acuity. Thus, it is clinically significant to study the changes in visual fields in eyes with CRAO. Sequential evaluation by Humphrey perimetry will evaluate the temporal changes before and after IAT or conservative therapies. Our study will enroll patients within 7 days of symptom onset and aims at evaluating the safety of IAT and comparing the improvement of the VFDs between conservative treatments and IAT combined with conservative treatments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IAT combined with conservative therapies | Experimental | IAT (Drug: 50 mg Alteplase)+conservative treatments |
|
| Conservative therapies | Other | conservative treatments including traditional ones and hyperbaric oxygen therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-arterial thrombolysis | Procedure | IAT introduces rt-PA directly into the ophthalmic circulation by super-selective microcatheterization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 3 months | Change of the mean deviation | 90 days |
| Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 3 months | Change of the visual field index | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Best corrected visual acuity (BCVA) at 3 months | best corrected visual acuity of logarithm of the minimum angle of resolution | 90 days |
| Adverse reactions at 1 month | Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Ocular factor or disease
Systemic factors restricting thrombolysis
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Fei | Contact | 15000672472 | shirleypingfei@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ping Fei, MD#PhD | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200092 | China |
protocols
90 days after the interventions
if required propriately
Not provided
Not provided
| ID | Term |
|---|---|
| D015356 | Retinal Artery Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| conservative treatments | Other | conservative treatments |
|
| 30 days |
| D002318 |
| Cardiovascular Diseases |