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Application of tPA in Suprachoroidal and Subretinal Hemorrhage

Application of tPA in Suprachoroidal and Subretinal Hemorrhage

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05736757
Enrollment
20
Registered
2023-02-21
Start date
2022-12-01
Completion date
2026-07-31
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Trauma

Keywords

suprachoroidal hemorrhage, subretinal hemorrhage

Brief summary

Severe ocular rupture may be accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage. The suprachoroidal hemorrhage needs to be drained as soon as possible. In the process of waiting for the spontaneous liquefaction of hemorrhage, uncontrollable elevated intraocular pressure may occur, resulting in optic nerve injury, optic nerve atrophy, and visual loss. Tissue plasminogen activator can promote the liquefaction of blood clots. Studies have found that local application of tissue plasminogen activator in the suprachoroidal space can promote the liquefaction of the hemorrhage. Local application of tissue fibrinogen activator under the retina can promote the liquefaction of subretinal hemorrhage.

Detailed description

Severe ocular rupture may be accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage. The suprachoroidal hemorrhage needs to be drained as soon as possible. The traditional treatment method needs to wait for the spontaneous liquefaction of the suprachoroidal hemorrhage, and then perform scleral incision to drain the liquefied suprachoroidal hemorrhage. However, in the process of waiting for the spontaneous liquefaction of suprachoroidal hemorrhage, uncontrollable elevated intraocular pressure may occur, resulting in optic nerve injury, optic nerve atrophy, and visual loss. In addition, if the suprachoroidal hemorrhage is not completely liquefied, it will not be completely drained, which will lead to choroidal function damage, low intraocular pressure and eyeball atrophy. Severe ocular rupture can be accompanied by a large amount of subretinal hemorrhage. The traditional treatment is to open the retina in a large area and drain the subretinal hemorrhage. However, extensive retinal incision has great damage, vitreoretinal proliferation often occurs after surgery, leading to recurrent retinal detachment, large area of choroid exposure, low intraocular pressure, and atrophy of the eye. Tissue plasminogen activator can promote the liquefaction of blood clots. Studies have found that local application of tissue plasminogen activator in the suprachoroidal space can promote the liquefaction of the hemorrhage near the suprachoroidal space, and can drain the hemorrhage of the suprachoroidal space smoothly and completely in the early stage. Local application of tissue plasminogen activator under the retina can promote the liquefaction of subretinal hemorrhage. Through small retinal incision, subretinal hemorrhage can be completely drained, the scope of retinal incision can be reduced, vitreoretinal proliferation can be reduced, and the occurrence of recurrent retinal detachment after surgery can be reduced.

Interventions

Injection of 50 ug tissue plasminogen activator into the suprachoroidal cavity or subretinal space to assist in bleeding liquefaction

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomly divided into control group (without tissue fibrinogen activator) or drug group (injection of 50 ug tissue fibrinogen activator into the suprachoroidal cavity or subretinal space ).

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with severe ocular rupture accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage

Exclusion criteria

* Rupture of eyeball accompanied by a small amount of suprachoroidal hemorrhage or a small amount of subretinal hemorrhage

Design outcomes

Primary

MeasureTime frameDescription
Best corrected visual acuitythrough study completion, an average of 2 yearBest corrected visual acuity

Secondary

MeasureTime frameDescription
Intraocular pressurethrough study completion, an average of 2 yearIntraocular pressure

Countries

China

Contacts

Primary ContactZhitao Su, Ph.D
suzhitao@zju.edu.cn86 0571 87783759

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026