Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

Not Applicable

Completed

• Conditions: Epiretinal Membrane

• Registration Number: NCT01474655
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to evaluate the changes in visual acuity, metamorphopsia, and thickness of retinal layers after epiretinal membrane removal and to investigate factors associated with visual function.

Detailed Description

Eyes with idiopathic Epiretinal Membrane Removal (ERM) scheduled to underwent ERM removal were included. Changes in visual acuity, metamorphopsia score (M-score) using M-chart, and parafoveal thickness of each retinal layer were evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits. Factors associated with visual acuity and M-score were investigated.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2011-10-21
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-15
• Last Update Submitted: 2011-11-15
• Study First Posted: 2011-11-18
• Last Update Posted: 2011-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients who were diagnosed with idiopathic epiretinal membrane and were scheduled for epiretinal membrane removal

Exclusion Criteria

• evidence of ocular inflammation, diabetic retinopathy, hypertensive retinopathy, and retinal vasculitis, media opacity that would influence visual acuity or preclude acquisition of clear spectral domain optical coherence tomography images,
• presence of cataract judged to affect visual function, -6.0 diopters or more of spherical equivalent, prominent staphyloma, history of intraocular surgery other than uncomplicated cataract surgery, history of retinal detachment, other ocular diseases that may influence the macular microstructure or visual function, immeasurable fovea location on the spectral domain optical coherence tomography image due to severe retinal contraction, and indistinct intraretinal structure on spectral domain optical coherence tomography images.
• patients who underwent combined epiretinal membrane removal and cataract extraction, less than six months follow-up after epiretinal membrane removal, who had occurrence or progression of cataract after the surgery judged to affect visual function, or who experienced recurrence of epiretinal membrane during the follow-up period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Postoperative changes in visual acuity	preop, 2-month postop, 6-months postop	Changes in visual acuity (Early treatment diabetic retinopathy study score)was evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits.
Postoperative changes in metamorphopsia	preop, 2 months postop, 6 months postop	Changes in metamorphopsia score (M-score) was measured using M-chart and evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits.
Postoperative parafoveal thickness of each retinal layer	preop, 2 months postop, 6 months postop	Changes in parafoveal thickness of each retinal layer was evaluated based on spectral domain optical coherence tomography images