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Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery

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ClinicalTrials.gov Identifier: NCT01549249
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University

Study Description
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Brief Summary:
The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM) surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Device: optical coherence tomography Not Applicable

Detailed Description:
Epiretinal membrane (ERM) may cause decreased central vision or metamorphopsia. Pars plana vitrectomy with membrane peeling has become the standard treatment for epiretinal membrane. However, visual recovery or symptomatic relief is not always satisfactory in all eyes despite successful membrane removal. Spectral domain optical coherence tomography (SD-OCT) is a non-invasive imaging device for various vitreoretinal diseases. Cone outer segment tips (COST) line is a line observed between IS/OS line and RPE in SD-OCT. The investigators examined the correlation of visual acuity and the recovery of photoreceptor layer after ERM surgery, taking COST line into account as a new parameter
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
Study Start Date : June 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2011
Arms and Interventions
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Arm Intervention/treatment
No Intervention: vitrectomy Device: optical coherence tomography
spectral-domain optical coherence tomography
Other Name: vitreous surgery


Outcome Measures
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Primary Outcome Measures :
  1. best-corrected visual acuity [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who received epiretinal membrane surgery between June, 2008, and November, 2010, at Kyorin Eye Center.
  • Only eyes with postoperative follow-up period more than 6 months were included.

Exclusion Criteria:

  • Eyes with secondary epiretinal membrane (previous history of uveitis, intraocular surgery, pre-operatively noted retinal breaks, etc.) were excluded.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549249


Locations
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Japan
Kyorin Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
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Principal Investigator: Makoto Inoue, MD Kyorin Eye Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier: NCT01549249    
Other Study ID Numbers: KyorinEye007
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012
Keywords provided by Makoto Inoue, Kyorin University:
cone outer segment tips line
inner segment/outer segment junction line
optical coherence tomography
epiretinal membrane
Additional relevant MeSH terms:
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Epiretinal Membrane
Retinal Diseases
Eye Diseases