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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01985490
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arm: 1
• Duration (Months): 17.9
• Patients Per Site Per Month: 1.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane	Procedure: epiretinal membrane and internal limiting membrane removal	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2013
• Anticipated Primary Completion Date: Nov 1, 2014
• Anticipated Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: epiretinal membrane	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.

Outcome Measures

Primary Outcome Measures

1. area of foveal avascular zone [postoperative 6 months]

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

Secondary Outcome Measures

1. change in visual acuity [postoperative 6 months]

2. change in macular thickness [at 6 months]

3. change in metamorphopsia [postoperative 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Se Woong Kang, MD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01985490
• Other Study ID Numbers: 2013-07-163
• First Posted: Nov 15, 2013
• Last Update Posted: Nov 26, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Samsung Medical Center: epiretinal membrane; foveal avascular zone; internal limiting membrane
• Additional relevant MeSH terms: Epiretinal Membrane

Study Results

No Results Posted as of Nov 26, 2013