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Clinicopathologic Findings for Macular Disease

Sponsor
Hallym University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00994227
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
13
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

this study is to analyze and compare the ultrastructure of the retinal and vitreous plane of the epiretinal membrane and internal limiting membrane removed during macular surgery and to evaluate relation between the ultrastructure of the epiretinal membrane and internal limiting membrane and surgical outcomes.

Condition or Disease Intervention/Treatment Phase
  • Procedure: vitrectomy for macular disease
 N/A

Detailed Description

prospective, interventional study and includes patients who underwent vitrectomy,peeling of an epiretinal membrane and internal limiting membrane excision with or without intraoperative intraocular ICG injection.

Excised specimens were placed on a Millipore filter, fixed in a paraformaldehyde solution, and examined by light and transmission electron microscopy. Ultrathin sections were stained with uranyl acetate-lead citrate and inspected in a Zeiss EM electron microscope. The assessment was done in a blinded, masked fashion so that the clinicians who reviewed the histologic specimens

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinicopathologic Findings for Macular Disease
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: surgery

Procedure: vitrectomy for macular disease
three-port pars plana vitrectomy was performed in each case using a vitreous cutter surrounded by a coaxial optic fiber connected to a xenon light source (Lausanne set, Oertli, Switzerland-developed at Jules Gonin, Lausanne, by Gonvers and Bovey). Separation of the posterior hyaloid membrane was performed when necessary. Visualization of the fundus was achieved with a special noncontact wide-angle viewing system 37 during vitrectomy and with a planoconcave contact lens for macular peeling. The MEM was peeled in the macular area using an end gripping forceps.
Other Names:
  • vitrectomy(DORC)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. spectral domain optical coherence tomography [baseline, 1week, 1month, 3 month]

      The central 1mm subfield thickness the average macular thickness the inner nuclear layer thickness outer nuclear layer thickness outer plexiform layer thickness photoreceptor integrity ILM map RPE map

    2. best corrected visual acuity [baseline, 1 month, 3 months]

      logMAR

    Secondary Outcome Measures

    1. electron microscopy finding of internal limiting membrane [during operation]

    2. visual field [baseline, postoperative 1 months, 3 months]

      humpley visual field

    3. preferential hyperacuity perimeter [baseline, postoperative 1 months, 3 months]

      ForeseePHP 2.05; Notal Vision, Tel Aviv, Israel

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients who underwent vitrectomy,peeling of an idiopathic MEM and ILM excision with or without intraoperative intraocular ICG injectio
    Exclusion Criteria:
    • the presence of macular hole or lamellar macular hole previous vitreoretinal surgery the presence of any other macular pathologic features potentially interfering with histologic results (such as diabetic retinopathy or age-related macular degeneration).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 JiWon Lim Seoul Korea, Republic of

    Sponsors and Collaborators

    • Hallym University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00994227
    Other Study ID Numbers:
    • 2009-10-10
    First Posted:
    Oct 14, 2009
    Last Update Posted:
    Apr 21, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    electron microscopy
    internal limiting membrane
    macular disease
    optical coherence tomography

    Study Results

    No Results Posted as of Apr 21, 2011