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Early Vitrectomy for Macular Tractional Maculopathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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

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   (Adult, Senior)
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
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: NCT01121978

Locations
Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 82-2-3010-3673, Korea, Republic of, 138-736
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, Korea, Republic of, 463-707
Konyang University, Myung Gok Eye Research Institute
Daejeon, Korea, Republic of, 302-718
HanGil Eye Hospital
In Cheon, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
Seoul, Korea, Republic of, 134-701
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Gangnam Sacred Heart Hospital,Hallym University
Seoul, Korea, Republic of, 150-950
Kong eye clinic
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul Retina Investigator Group
Investigators
Principal Investigator: Se Woong Kang, M.D. Seoul Retina Investigator Group
  More Information

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 Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on December 02, 2016