Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm

NCT02120066 — Not applicable, Completed, 22 participants, Kyorin University

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Registry	NCT02120066
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	22 (Actual)
Sponsor	Kyorin University (Other)
Conditions	Submacular Hemorrhage, Ruptured Retinal Arterial Macro Aneurysms
Interventions	Vitrectomy for submacular hemorrhage, subretinal injection of tissue-plasminogen activator (Procedure, drug)
Dates	start 2011-01-01, primary completion 2013-06-01, completion 2014-04-01, first posted 2014-04-22, last updated 2014-04-22
Locations	1 site in Japan

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Vitrectomy	Other	Procedure: Vitrectomy for submacular hemorrhage; Drug: subretinal injection of tissue-plasminogen activator

Vitrectomy for submacular hemorrhage (Procedure)
subretinal injection of tissue-plasminogen activator (Drug)

+Outcome measures

Primary outcomes

Displacement of sub macular hemorrhage [one year]: Anatomical recovery detected funduscopy and optical coherence tomography

Secondary outcomes

Visual acuity [one year]: Visual recovery after surgery

+Eligibility

Sex: All, ages: 40 Years to 95 Years

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

+Locations (1)

Facility	City	Country	Status
Kyorin Eye Center	Mitaka, Tokyo	Japan