Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

Conditions
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Epiretinal Membrane

Intervention / Treatment
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* Procedure: Pars plana vitrectomy and removal of epiretinal membrane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pars plana vitrectomy and removal of epiretinal membrane|A three-port standard pars plana vitrectomy was performed by a single surgeon using a 23-gauge vitrectomy system, either Associate®(Dutch Ophthalmic Research Center. Inc., Zuidland, The Netherlands) or Accurus®(Alcon Laboratories Inc., Fort Worth, USA), with one step scleral tunnel incision. Visualization of the fundus was achieved using a wide-angle viewing system. After core vitrectomy, induction of a posterior vitreous detachment was conducted using a 23-gauge angulated dissecting needle in cases without presence of a posterior vitreous detachment. The epiretinal membrane and internal limiting membrane was removed in all eyes. In most cases, internal limiting membrane was removed without the assistance of staining dye. Indocyanine green dye was used to facilitate the removal of internal limiting membrane in some of the cases.|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epiretinal membrane, visual acuity, metamorphopsia, thickness of retinal layers, spectral domain optical coherence tomography