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

Primary Purpose

Epiretinal Membrane

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
epiretinal membrane and internal limiting membrane removal
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiretinal Membrane focused on measuring epiretinal membrane, foveal avascular zone, internal limiting membrane

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

epiretinal membrane

Arm Description

Outcomes

Primary Outcome Measures

area of foveal avascular zone
the change in area of foveal avascular zone at postoperative 6 months

Secondary Outcome Measures

change in visual acuity
change in macular thickness
change in metamorphopsia

Full Information

First Posted
November 10, 2013
Last Updated
November 25, 2013
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01985490
Brief Title
Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
Keywords
epiretinal membrane, foveal avascular zone, internal limiting membrane

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
epiretinal membrane
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
epiretinal membrane and internal limiting membrane removal
Intervention Description
fluorescein angiography is performed before, 1 week, 3months and 6months after the epiretinal membrane and internal limiting membrane removal.
Primary Outcome Measure Information:
Title
area of foveal avascular zone
Description
the change in area of foveal avascular zone at postoperative 6 months
Time Frame
postoperative 6 months
Secondary Outcome Measure Information:
Title
change in visual acuity
Time Frame
postoperative 6 months
Title
change in macular thickness
Time Frame
at 6 months
Title
change in metamorphopsia
Time Frame
postoperative 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Se Woong Kang, MD
Phone
82-2-3410-3562
Email
swkang@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, MD
Phone
82-2-3410-3562
Email
swkang@skku.edu
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, MD
First Name & Middle Initial & Last Name & Degree
Ga Eun Cho, MD

12. IPD Sharing Statement

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

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