Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal
Primary Purpose
Epiretinal Membrane
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pars plana vitrectomy and removal of epiretinal membrane
Sponsored by
About this trial
This is an interventional diagnostic trial for Epiretinal Membrane focused on measuring epiretinal membrane, visual acuity, metamorphopsia, thickness of retinal layers, spectral domain optical coherence tomography
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01474655
First Posted
October 21, 2011
Last Updated
November 15, 2011
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01474655
Brief Title
Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal
Official Title
Assessment of Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
Keywords
epiretinal membrane, visual acuity, metamorphopsia, thickness of retinal layers, spectral domain optical coherence tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy and removal of epiretinal membrane
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative changes in visual acuity
Description
Changes in visual acuity (Early treatment diabetic retinopathy study score)was evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits.
Time Frame
preop, 2-month postop, 6-months postop
Title
Postoperative changes in metamorphopsia
Description
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.
Time Frame
preop, 2 months postop, 6 months postop
Title
Postoperative parafoveal thickness of each retinal layer
Description
Changes in parafoveal thickness of each retinal layer was evaluated based on spectral domain optical coherence tomography images
Time Frame
preop, 2 months postop, 6 months postop
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, M.D.
Organizational Affiliation
Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22875136
Citation
Kim JH, Kang SW, Kong MG, Ha HS. Assessment of retinal layers and visual rehabilitation after epiretinal membrane removal. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1055-64. doi: 10.1007/s00417-012-2120-7. Epub 2012 Aug 9.
Results Reference
derived
Learn more about this trial
Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal
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