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Submacular Hemorrhage Treated by Subretinal Tissue Plasminogen Activator: A Prospective, Interventional, Multicenter Randomized Controlled Study

Submacular Hemorrhage Treated by Subretinal Tissue Plasminogen Activator: A Prospective, Interventional, Multicenter Randomized Controlled Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053034
Enrollment
Unknown
Registered
2021-11-10
Start date
2021-11-10
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Submacular hemorrhage

Interventions

experimental group:Subretinal injection with alteplase alitone treatment group
control group:Intravitreal injection of anti VEGF

Sponsors

Wuhan Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years and diagnosed with submacular hemorrhage; 2. The visual acuity decreased significantly, the diameter of SMH was greater than 2 DD, and the duration of symptoms was less than 28 days; 3. Submacular hemorrhage with thickness greater than 250mm measured by optical coherence tomography (OCT); 4. With the approval of the medical ethics committee, patients and their families voluntarily sign informed consent; 5. No serious systemic basic diseases; 6. The clinical data are complete.

Exclusion criteria

Exclusion criteria: 1. PCV patients who have not received fundus clot removal or pneumatic replacement; 2. Patients who have not been followed up for at least 1 year; 3. Patients who are clinically considered to have extensive hemorrhage under the RPE, and those with massive subretinal hemorrhage (defined as hemorrhage extending to the equator); 4. Patients with poor compliance and unable to complete follow-up.

Design outcomes

Primary

MeasureTime frame
Optical coherence tomography;Best corrected visual acuity;Fundus photography;Optical coherence tomography angiography;Intraocular pressure;anteroposterior axis;Slit lamp fundus examination;Optical Biometry;Ultrasonic examination;fundus fluorescein angiography;

Countries

China

Contacts

Public ContactSun Xufang

Wuhan Tongji Hospital

s_1862777@163.com+86 18627770651

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026