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NCT01985490 Clinical Trial

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

Epiretinal Membrane Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01985490
Other study ID # 2013-07-163
Secondary ID
Status Recruiting
Phase N/A
First received November 10, 2013
Last updated November 25, 2013
Start date November 2013
Est. completion date May 2015

Study information
Verified date November 2013
Source Samsung Medical Center
Contact Se Woong Kang, MD
Phone 82-2-3410-3562
Email swkang@skku.edu
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 32
Est. completion date May 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• epiretinal membrane and internal limiting membrane removal
fluorescein angiography is performed before, 1 week, 3months and 6months after the epiretinal membrane and internal limiting membrane removal.

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary area of foveal avascular zone the change in area of foveal avascular zone at postoperative 6 months postoperative 6 months No
Secondary change in visual acuity postoperative 6 months No
Secondary change in macular thickness at 6 months No
Secondary change in metamorphopsia postoperative 6 months No
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Terminated NCT04802265 - EpiRetinal Membrane Peeling and Internal Limiting Membrane