Early Vitrectomy for Macular Tractional Maculopathy

March 28, 2011 updated by: Seoul Retina Investigator Group

Early Vitrectomy for Macular Tractional Maculopathy. Multicenter Clinical Trial

This study is designed to identify the effect of current vitreous surgery for symptomatic macular tractional maculopathy.

Characteristics of this study is as below

  1. Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole formation or deterioration of visual acuity occurs)
  2. Non-randomized study (decision was made by patients after full explanation)
  3. After 1 year follow up, functional change(visual acuity)and anatomical change would be evaluated

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Degenerative myopia is relatively common disorder, especially in Korean, Japanese and Chinese.

Choroidal neovascularization is well-noted cause of VA deterioration, but nowadays, with improvement of diagnostic tools, such as OCT, VA deterioration from myopic tractional maculopathy is being concerned as well.

But till now, the necessity of early vitrectomy on MTM is controversial. By now some clinicians prefer conservative treatment, which means pars plana vitrectomy would be postponed till structural change such as macular hole formation is noticed. And the others prefer early vitrectomy, which means pars plana vitrectomy should be performed when the symptom begins.

In this study, investigators try to verify the validity of early vitrectomy comparing conservative treatment.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Se Woong Kang, M.D.
  • Phone Number: 82-2-3410-6776
  • Email: swkang@skku.edu

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 302-718
        • Recruiting
        • Konyang University, Myung Gok Eye Research Institute
        • Contact:
          • Jong Woo Kim, M.D.
          • Phone Number: 82-42-600-8816
        • Principal Investigator:
          • Jong Woo Kim, M.D.
      • In Cheon, Korea, Republic of
        • Recruiting
        • HanGil Eye Hospital
        • Contact:
          • Joonhong Sohn, M.D.
          • Phone Number: 0325033322
        • Principal Investigator:
          • Joonhong Sohn, M.D.
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Hum Chung, M.D.
          • Phone Number: 82-2-2072-2437
        • Principal Investigator:
          • Hum Chung, M.D.
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Se Woong Kang, M.D.
      • Seoul, Korea, Republic of, 134-701
        • Recruiting
        • Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
        • Contact:
          • Sung Pyo Park, M.D.
          • Phone Number: 82-2-2224-2274
        • Principal Investigator:
          • Sung Pyo Park, M.D.
      • Seoul, Korea, Republic of, 137-701
        • Recruiting
        • Catholic University of Korea
        • Contact:
          • Won-Ki Lee, M.D.
          • Phone Number: 82-2-2258-2846
        • Principal Investigator:
          • Won-Ki Lee, M.D.
      • Seoul, Korea, Republic of, 150-950
        • Recruiting
        • Gangnam Sacred Heart Hospital,Hallym University
        • Contact:
          • Ha Kyoung Kim, M.D.
          • Phone Number: 82-2-829-5193
        • Principal Investigator:
          • Ha Kyoung Kim, M.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Kong eye clinic
        • Contact:
          • Eun Goo Lee, M.D.
          • Phone Number: 02-480-5000
        • Principal Investigator:
          • Eun Goo Lee, M.D.
    • 82-2-3010-3673
      • Seoul, 82-2-3010-3673, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center, University of Ulsan College of Medicine
        • Contact:
          • Young Hee Yoon, M.D.
          • Phone Number: 82-2-3010-3673
        • Principal Investigator:
          • Young Hee Yoon, M.D.
    • Gyunggi-do
      • Seongnam, Gyunggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Kyu Hyung Park, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female with impending macular hole(identified with OCT)
  • Age: over 20 years
  • Symptom duration < 6 Months
  • Visual acuity on trial: more than 20/320 in ETDRS chart

Exclusion Criteria:

  • Any vision disturbing disease other than impending macular hole
  • Diabetic maculopathy or other retinal vascular disease
  • Prior history of major trauma: If symptom begins after trauma
  • Any evidence of atrophic change, scar or exudation on macula active intraocular inflammation
  • History of intraocular surgery other than uncomplicated cataract extraction 3 months before
  • Uncontrolled IOP > 25mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conservative treatment group
Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole or vision deterioration occurs
Experimental: Early vitrectomy
Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling
Procedure: Early vitrectomy
Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling
Other Names:
  • pars plana vitrectomy for macular tractional maculopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual acuity
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of occurrence of full-thickness macular hole
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul Retina Investigator Group

Investigators

  • Principal Investigator: Se Woong Kang, M.D., Seoul Retina Investigator Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

April 30, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 29, 2011

Last Update Submitted That Met QC Criteria

March 28, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRIG #2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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