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

Sponsor
Kyorin University (Other)
Overall Status
Completed
CT.gov ID
NCT01549249
Collaborator
(none)
333
Enrollment
1
Location
1
Arm
41
Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: optical coherence tomography
 N/A

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

Study Type:
Interventional
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 :
Jun 1, 2008
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
No Intervention: vitrectomy

Device: optical coherence tomography
spectral-domain optical coherence tomography
Other Names:
  • vitreous surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. best-corrected visual acuity [one year]

    Secondary Outcome Measures

    1. Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Kyorin Eye Center Mitaka Tokyo Japan 181-8611

    Sponsors and Collaborators

    • Kyorin University

    Investigators

    • Principal Investigator: Makoto Inoue, MD, Kyorin Eye Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Makoto Inoue, Associate professor, Kyorin University
    ClinicalTrials.gov Identifier:
    NCT01549249
    Other Study ID Numbers:
    • KyorinEye007
    First Posted:
    Mar 9, 2012
    Last Update Posted:
    Nov 14, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Makoto Inoue, Associate professor, Kyorin University
    cone outer segment tips line
    inner segment/outer segment junction line
    optical coherence tomography
    epiretinal membrane
    Additional relevant MeSH terms:
    Epiretinal Membrane

    Study Results

    No Results Posted as of Nov 14, 2012