Removal of Massive Subretinal Organized Blood Clot With Fragmatome

Age-Related Macular Degeneration Clinical Trial

Official title:

Removal of Massive Subretinal Organized Blood Clot With Fragmatome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196049
• Other study ID #: 191203
• Status: Completed
• Start date: January 7, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: December 2019
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

By using the ultrasound power delivered by fragmatome, the hard, organized blood clot could be removed easily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 29, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with massive subretinal hemorrhage from age related macular degeneration

• Patients had organized subretinal blood clot were managed by inferior retinectomy.

Exclusion Criteria:

• Patients without massive subretinal hemorrhage

• Patients were not age related macular degeneration.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Thrombosis

Intervention

Procedure:
• fragmatome
Patients with massive subretinal hemorrhage from age related macular degeneration and organized subretinal blood clot were managed by inferior retinectomy. The subretinal organized blood clot was dragged to the preretinal space and removed by fragmatome. The retinal was reattached with perfluorocarbon liquid and laser was applied at the margin of retinectomy. Silicon oil was infused at the end of surgery.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	visual acuity change in logMAR in different time point	Before operation, 1 weeks after operation, 1 month after operation.
Primary	spherical equivalent	spherical power + half of cylinder power	Before operation