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Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

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ClinicalTrials.gov Identifier: NCT01474655
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : November 18, 2011
Sponsor:
Information provided by (Responsible Party):
Se Woong, Kang, 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.

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Procedure: Pars plana vitrectomy and removal of epiretinal membrane Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal
Study Start Date : September 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources


Intervention Details:
    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.


Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474655


Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Se Woong Kang, M.D. Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Se Woong, Kang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01474655     History of Changes
Other Study ID Numbers: 2011-07-069
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: November 2011

Keywords provided by Se Woong, Kang, Samsung Medical Center:
epiretinal membrane
visual acuity
metamorphopsia
thickness of retinal layers
spectral domain optical coherence tomography

Additional relevant MeSH terms:
Epiretinal Membrane
Retinal Diseases
Eye Diseases