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Early Vitrectomy for Macular Tractional Maculopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Seoul Retina Investigator Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul Retina Investigator Group
ClinicalTrials.gov Identifier:
NCT01121978
First received: April 30, 2010
Last updated: March 28, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention
Myopia, Degenerative
 Procedure: Early vitrectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Vitrectomy for Macular Tractional Maculopathy. Multicenter Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul Retina Investigator Group:

Primary Outcome Measures:
  • Best Corrected Visual acuity [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of occurrence of full-thickness macular hole [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121978

Contacts
Contact: Se Woong Kang, M.D. 82-2-3410-6776 swkang@skku.edu
Contact: Se Woong Kang 82234103562 swkang@skku.edu

Locations
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     jiani4@snu.ac.kr    
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.            
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Se Woong Kang, M.D.     82-2-3410-3562     swkang@skku.edu    
Principal Investigator: Se Woong Kang, 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.            
Kong eye clinic Recruiting
Seoul, Korea, Republic of
Contact: Eun Goo Lee, M.D.     02-480-5000        
Principal Investigator: Eun Goo Lee, 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.            
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.            
Sponsors and Collaborators
Seoul Retina Investigator Group
Investigators
Principal Investigator: Se Woong Kang, M.D. Seoul Retina Investigator Group
  More Information

No publications provided

Responsible Party: Se Woong Kang, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01121978     History of Changes
Other Study ID Numbers: SRIG #2
Study First Received: April 30, 2010
Last Updated: March 28, 2011
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Myopia
Myopia, Degenerative
Refractive Errors
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013