NCT02120066

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
Last Updated

April 22, 2014

Status Verified

April 1, 2014

Enrollment Period

2.4 years

First QC Date

April 15, 2014

Last Update Submit

April 18, 2014

Conditions

Submacular HemorrhageRuptured Retinal Arterial Macro Aneurysms

Keywords

Submacular hemorrhageVitrectomytissue- plasminogen activator

Outcome Measures

Primary Outcomes (1)

  • Displacement of sub macular hemorrhage

    Anatomical recovery detected funduscopy and optical coherence tomography

    one year

Secondary Outcomes (1)

  • Visual acuity

    one year

Study Arms (1)

Vitrectomy

OTHER
Procedure: Vitrectomy for submacular hemorrhageDrug: subretinal injection of tissue-plasminogen activator

Interventions

Vitrectomy for submacular hemorrhagePROCEDURE
Vitrectomy
subretinal injection of tissue-plasminogen activatorDRUG
Vitrectomy

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • The eyes with preretinal or intraretinal hemorrhage at the fovea
  • The patients with follow-up less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

Related Links

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Ophthalmology

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 22, 2014

Study Start

January 1, 2011

Primary Completion

June 1, 2013

Study Completion

April 1, 2014

Last Updated

April 22, 2014

Record last verified: 2014-04

Locations

JP(1)