Clinical trial NCT05736757: Application of tPA in Suprachoroidal and Subretinal Hemorrhage
Official title: Application of tPA in Suprachoroidal and Subretinal Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ocular Trauma
Keywords: suprachoroidal hemorrhage
subretinal hemorrhage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 ).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Intraocular pressure
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: