Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Se Woong, Kang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01474655
First received: October 21, 2011
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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 Intervention
Epiretinal Membrane
Procedure: Pars plana vitrectomy and removal of epiretinal membrane

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Postoperative changes in visual acuity [ Time Frame: preop, 2-month postop, 6-months postop ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in parafoveal thickness of each retinal layer was evaluated based on spectral domain optical coherence tomography images


Enrollment: 52
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.
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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Samsung Medical Center

Additional 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
Study First Received: October 21, 2011
Last Updated: November 15, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014