Application of tPA in Suprachoroidal and Subretinal Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ocular Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 ).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Control group (no tissue fibrinogen activator)

Group Type NO_INTERVENTION

No interventions assigned to this group

Drug group

Drug group (injection of 50 ug tissue fibrinogen activator into the suprachoroidal cavity or subretinal space )

Group Type EXPERIMENTAL

Tissue Plasminogen Activator

Intervention Type DRUG

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

Interventions

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Tissue Plasminogen Activator

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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