Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

NCT01474655 | Completed

• 1 other identifier: 2011-07-069
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epiretinal Membrane

Keywords

epiretinal membrane; visual acuity; metamorphopsia; thickness of retinal layers; spectral domain optical coherence tomography

Outcome Measures

Primary Outcomes (3)

• 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.

  preop, 2-month postop, 6-months postop

• 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.

  preop, 2 months postop, 6 months postop

• 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

  preop, 2 months postop, 6 months postop

Interventions

Pars plana vitrectomy and removal of epiretinal membrane PROCEDURE

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.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were diagnosed with idiopathic epiretinal membrane and were scheduled for epiretinal membrane removal

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Related Publications (1)

• 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.

  PMID: 22875136 DERIVED

MeSH Terms

Conditions

Epiretinal Membrane; Vision Disorders

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Se Woong Kang, M.D.

  Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: November 18, 2011
• Study Start: September 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 18, 2011

Record last verified: 2011-11