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Application of tPA in Suprachoroidal and Subretinal Hemorrhage

Primary Purpose

Ocular Trauma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tissue Plasminogen Activator
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Trauma focused on measuring suprachoroidal hemorrhage, subretinal hemorrhage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Drug group

Arm Description

Control group (no tissue fibrinogen activator)

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

Outcomes

Primary Outcome Measures

Best corrected visual acuity
Best corrected visual acuity

Secondary Outcome Measures

Intraocular pressure
Intraocular pressure

Full Information

First Posted
February 8, 2023
Last Updated
February 20, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05736757
Brief Title
Application of tPA in Suprachoroidal and Subretinal Hemorrhage
Official Title
Application of tPA in Suprachoroidal and Subretinal Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Trauma
Keywords
suprachoroidal hemorrhage, subretinal hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 ).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group (no tissue fibrinogen activator)
Arm Title
Drug group
Arm Type
Experimental
Arm Description
Drug group (injection of 50 ug tissue fibrinogen activator into the suprachoroidal cavity or subretinal space )
Intervention Type
Drug
Intervention Name(s)
Tissue Plasminogen Activator
Intervention Description
Injection of 50 ug tissue plasminogen activator into the suprachoroidal cavity or subretinal space to assist in bleeding liquefaction
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Best corrected visual acuity
Time Frame
through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
Intraocular pressure
Description
Intraocular pressure
Time Frame
through study completion, an average of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhitao Su, Ph.D
Phone
86 0571 87783759
Email
suzhitao@zju.edu.cn
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhitao Su, Ph.D
Phone
86 0571 87783759
Email
suzhitao@zju.edu.cn

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=22949914&query_hl=1
Description
Tissue plasminogen activator-assisted vitrectomy for ruptured eye with suprachoroidal hemorrhage
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=29376008&query_hl=1
Description
Tissue plasminogen activator-assisted vitrectomy in the early treatment of acute massive suprachoroidal hemorrhage complicating cataract surgery
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=21383941&query_hl=1
Description
Recombinant tissue plasminogen activator in the treatment of suprachoroidal hemorrhage
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10749314&query_hl=1
Description
Tissue plasminogen activator in the treatment of vitreoretinal diseases
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9486552&query_hl=1
Description
Treatment of suprachoroidal hemorrhage with tissue plasminogen activator
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=2115030&query_hl=1
Description
Treatment of experimental suprachoroidal hemorrhage with intravenous tissue plasminogen activator

Learn more about this trial

Application of tPA in Suprachoroidal and Subretinal Hemorrhage

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