Submacular Hemorrhage Associated With Retinal Arterial Ma... | NCT02120066

Studies
Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm

NCT02120066

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Apr 22, 2014Estimated

Enrollment

22Actual

Phase

Not Applicable

Conditions

Submacular Hemorrhage
Ruptured Retinal Arterial Macro Aneurysms

Interventions

Vitrectomy for submacular hemorrhage
subretinal injection of tissue-plasminogen activator

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Apr 2014Actual

First Submitted Date

Apr 15, 2014

First Submission Date that Met QC Criteria

Apr 18, 2014

First Posted Date

Apr 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2014

Last Update Posted Date

Apr 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitrectomy	Other		Procedure: Vitrectomy for submacular hemorrhage Drug: subretinal injection of tissue-plasminogen activator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy for submacular hemorrhage	Procedure		Vitrectomy
subretinal injection of tissue-plasminogen activator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Displacement of sub macular hemorrhage	Anatomical recovery detected funduscopy and optical coherence tomography	one year

Secondary Outcomes

Measure	Description	Time Frame
Visual acuity	Visual recovery after surgery	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyorin Eye Center		Mitaka	Tokyo	181-8611	Japan

Label	URL
Related Info	View source

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

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