Change in Foveal Avascular Zone After Removal of Epiretin... | NCT01985490

Studies
Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane

NCT01985490

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Nov 26, 2013Estimated

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Epiretinal Membrane

Interventions

epiretinal membrane and internal limiting membrane removal

Countries

South Korea

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Nov 2014Estimated

Completion Date

May 2015Estimated

First Submitted Date

Nov 10, 2013

First Submission Date that Met QC Criteria

Nov 10, 2013

First Posted Date

Nov 15, 2013Estimated

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

Nov 25, 2013

Last Update Posted Date

Nov 26, 2013Estimated

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

Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting membrane is frequently performed procedure and we suspected that these procedures may affect integrity of foveal avascular zone.

The purpose of the present study is to evaluate the change of foveal avascular zone after removal of epiretinal membrane and internal limiting membrane

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

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
epiretinal membrane	Experimental		Procedure: epiretinal membrane and internal limiting membrane removal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
epiretinal membrane and internal limiting membrane removal	Procedure	fluorescein angiography is performed before, 1 week, 3months and 6months after the epiretinal membrane and internal limiting membrane removal.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
area of foveal avascular zone	the change in area of foveal avascular zone at postoperative 6 months	postoperative 6 months

Secondary Outcomes

Measure	Description	Time Frame
change in visual acuity		postoperative 6 months
change in macular thickness		at 6 months
change in metamorphopsia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

epiretinal membrane

Exclusion Criteria:

history of vitrectomy, intraocular surgery
any macular disease other than epiretinal membrane
media opacity obscuring the image of fluorescein angiography

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Se Woong Kang, MD	Contact	82-2-3410-3562		swkang@skku.edu

Overall Officials

Name	Affiliation	Role
Se Woong Kang, MD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul	Seoul		South Korea

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided