Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinicopathologic Findings for Macular Disease

This study has been completed.
Sponsor:
Information provided by:
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT00994227
First received: October 13, 2009
Last updated: April 20, 2011
Last verified: April 2011
  Purpose

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 Intervention
Macular Disease
Procedure: vitrectomy for macular disease

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinicopathologic Findings for Macular Disease

Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • spectral domain optical coherence tomography [ Time Frame: baseline, 1week, 1month, 3 month ] [ Designated as safety issue: Yes ]
    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

  • best corrected visual acuity [ Time Frame: baseline, 1 month, 3 months ] [ Designated as safety issue: Yes ]
    logMAR


Secondary Outcome Measures:
  • electron microscopy finding of internal limiting membrane [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
  • visual field [ Time Frame: baseline, postoperative 1 months, 3 months ] [ Designated as safety issue: Yes ]
    humpley visual field

  • preferential hyperacuity perimeter [ Time Frame: baseline, postoperative 1 months, 3 months ] [ Designated as safety issue: Yes ]
    ForeseePHP 2.05; Notal Vision, Tel Aviv, Israel


Estimated Enrollment: 60
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: vitrectomy(DORC)

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994227

Locations
Korea, Republic of
JiWon Lim
Seoul, Korea, Republic of
Sponsors and Collaborators
Hallym University Medical Center
  More Information

No publications provided by Hallym University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: hallym unuversity medical center, department of ophthalmology
ClinicalTrials.gov Identifier: NCT00994227     History of Changes
Other Study ID Numbers: 2009-10-10
Study First Received: October 13, 2009
Last Updated: April 20, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Hallym University Medical Center:
electron microscopy
internal limiting membrane
macular disease
optical coherence tomography

ClinicalTrials.gov processed this record on November 20, 2014