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
60 participants
INTERVENTIONAL
2009-11-30
2012-11-30
Brief Summary
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Detailed Description
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Therefore, we designed this study to identify the effect of current vitreous surgery for symptomatic impending macular hole.
Characteristics of this study is as below
* Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole occurs)
* Non-randomized study (decision was made by patients after full explanation)
* After 1 year follow up, functional change(visual acuity)and anatomical change(development of full-thickness macular hole) would be evaluated
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 occurs
No interventions assigned to this group
Early vitrectomy
Pars plana vitrectomy with ILM peeling would be employed when visual symptoms occur.
Pars plana vitrectomy with ILM peeling
Pars plana vitrectomy with ILM peeling
Interventions
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Pars plana vitrectomy with ILM peeling
Pars plana vitrectomy with ILM peeling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: over 45 years
* Symptom duration \< 6 Months
* Visual acuity on trial: less than 73 letters in ETDRS chart Visual acuity of worsened eye: over 24 letters in ETDRS chart
Exclusion Criteria
* Diabetic maculopathy or other retinal vascular disease
* Prior history of major trauma: If symptom begins after trauma
* Myopia over -6.5Dioper or eyes with axial length \> 28mm
* Evidence of scar, degeneration or exudation of macula
* active intraocular inflammation
* History of intraocular surgery other than uncomplicated cataract extraction 3months before
* Uncontrolled IOP \> 25mmHg
45 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 #1
Identifier Type: -
Identifier Source: org_study_id
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