Clinical trial NCT01474655: 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
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Keywords: epiretinal membrane
visual acuity
metamorphopsia
thickness of retinal layers
spectral domain optical coherence tomography
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Postoperative changes in visual acuity
timeFrame: preop, 2-month postop, 6-months postop
measure: Postoperative changes in metamorphopsia
timeFrame: preop, 2 months postop, 6 months postop
measure: Postoperative parafoveal thickness of each retinal layer
timeFrame: preop, 2 months postop, 6 months postop
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Se Woong Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.