Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm

Submacular Hemorrhage Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120066
• Other study ID #: Kyorineye015
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: April 18, 2014
• Start date: January 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 95 Years

Eligibility

Inclusion Criteria:

• The patients with sub macular hemorrhage associated with ruptured retinal arterial macro aneurysms

Exclusion Criteria:

• The eyes with preretinal or intraretinal hemorrhage at the fovea

• The patients with follow-up less than 3 months

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Ruptured Retinal Arterial Macro Aneurysms
• Submacular Hemorrhage

Intervention

Procedure:
• Vitrectomy for submacular hemorrhage

Drug:
• subretinal injection of tissue-plasminogen activator

Locations

Country	Name	City	State
Japan	Kyorin Eye Center	Mitaka	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Displacement of sub macular hemorrhage	Anatomical recovery detected funduscopy and optical coherence tomography	one year	No
Secondary	Visual acuity	Visual recovery after surgery	one year	No

External Links

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