Early Vitrectomy for Macular Tractional Maculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121978
Recruitment Status : Unknown
Verified March 2011 by Seoul Retina Investigator Group.
Recruitment status was:  Recruiting
First Posted : May 12, 2010
Last Update Posted : March 29, 2011
Information provided by:
Seoul Retina Investigator Group

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Myopia, Degenerative Procedure: Early vitrectomy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Vitrectomy for Macular Tractional Maculopathy. Multicenter Clinical Trial
Study Start Date : November 2009
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2012

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 Name: pars plana vitrectomy for macular tractional maculopathy

Primary Outcome Measures :
  1. Best Corrected Visual acuity [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Rate of occurrence of full-thickness macular hole [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121978

Contact: Se Woong Kang, M.D. 82-2-3410-6776
Contact: Se Woong Kang 82234103562

Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, 82-2-3010-3673, Korea, Republic of, 138-736
Contact: Young Hee Yoon, M.D.    82-2-3010-3673      
Principal Investigator: Young Hee Yoon, M.D.         
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyunggi-do, Korea, Republic of, 463-707
Contact: Kyu Hyung Park, M.D    82-31-787-7373   
Principal Investigator: Kyu Hyung Park, M.D         
Konyang University, Myung Gok Eye Research Institute Recruiting
Daejeon, Korea, Republic of, 302-718
Contact: Jong Woo Kim, M.D.    82-42-600-8816      
Principal Investigator: Jong Woo Kim, M.D.         
HanGil Eye Hospital Recruiting
In Cheon, Korea, Republic of
Contact: Joonhong Sohn, M.D.    0325033322      
Principal Investigator: Joonhong Sohn, M.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Hum Chung, M.D.    82-2-2072-2437      
Principal Investigator: Hum Chung, M.D.         
Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Recruiting
Seoul, Korea, Republic of, 134-701
Contact: Sung Pyo Park, M.D.    82-2-2224-2274      
Principal Investigator: Sung Pyo Park, M.D.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Se Woong Kang, M.D.    82-2-3410-3562   
Principal Investigator: Se Woong Kang, M.D.         
Catholic University of Korea Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Won-Ki Lee, M.D.    82-2-2258-2846      
Principal Investigator: Won-Ki Lee, M.D.         
Gangnam Sacred Heart Hospital,Hallym University Recruiting
Seoul, Korea, Republic of, 150-950
Contact: Ha Kyoung Kim, M.D.    82-2-829-5193      
Principal Investigator: Ha Kyoung Kim, M.D.         
Kong eye clinic Recruiting
Seoul, Korea, Republic of
Contact: Eun Goo Lee, M.D.    02-480-5000      
Principal Investigator: Eun Goo Lee, M.D.         
Sponsors and Collaborators
Seoul Retina Investigator Group
Principal Investigator: Se Woong Kang, M.D. Seoul Retina Investigator Group

Responsible Party: Se Woong Kang, Samsung Medical Center Identifier: NCT01121978     History of Changes
Other Study ID Numbers: SRIG #2
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: March 29, 2011
Last Verified: March 2011

Keywords provided by Seoul Retina Investigator Group:
macular tractional maculopathy
pathologic myopia

Additional relevant MeSH terms:
Myopia, Degenerative
Refractive Errors
Eye Diseases
Triamcinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors