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Clinical Trials/NCT01474655
NCT01474655
Completed
Not Applicable

Assessment of Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

Samsung Medical Center0 sites52 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epiretinal Membrane
Sponsor
Samsung Medical Center
Enrollment
52
Primary Endpoint
Postoperative changes in visual acuity
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
July 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Se Woong, Kang

Professor

Samsung Medical Center

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

Outcomes

Primary Outcomes

Postoperative changes in visual acuity

Time Frame: 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

Time Frame: 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

Time Frame: 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

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