Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2009-11-30
2012-11-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
No interventions assigned to this group
Early vitrectomy
Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling
Early vitrectomy
Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling
Interventions
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Early vitrectomy
Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: over 20 years
* Symptom duration \< 6 Months
* Visual acuity on trial: more than 20/320 in ETDRS chart
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Seoul Retina Investigator Group
NETWORK
Responsible Party
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Samsung Medical Center
Principal Investigators
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Se Woong Kang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul Retina Investigator Group
Locations
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Asan Medical Center, University of Ulsan College of Medicine
Seoul, 82-2-3010-3673, South Korea
Konyang University, Myung Gok Eye Research Institute
Daejeon, Daejeon, South Korea
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, South Korea
HanGil Eye Hospital
Incheon, In Cheon, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Catholic University of Korea
Seoul, Seoul, South Korea
Gangnam Sacred Heart Hospital,Hallym University
Seoul, Seoul, South Korea
Kong eye clinic
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Young Hee Yoon, M.D.
Role: primary
Jong Woo Kim, M.D.
Role: primary
Joonhong Sohn, M.D.
Role: primary
Hum Chung, M.D.
Role: primary
Sung Pyo Park, M.D.
Role: primary
Won-Ki Lee, M.D.
Role: primary
Ha Kyoung Kim, M.D.
Role: primary
Eun Goo Lee, M.D.
Role: primary
Other Identifiers
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SRIG #2
Identifier Type: -
Identifier Source: org_study_id
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