Early Vitrectomy for Impending Macular Hole
1 other identifier
interventional
60
1 country
10
Brief Summary
This study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2009
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 30, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedMarch 29, 2011
March 1, 2011
2 years
April 30, 2010
March 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual acuity
48 weeks
Secondary Outcomes (1)
Rate of occurrence of full-thickness macular hole
48 weeks
Study Arms (2)
Conservative treatment group
NO INTERVENTIONEyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs
Early vitrectomy
EXPERIMENTALPars plana vitrectomy with ILM peeling would be employed when visual symptoms occur.
Interventions
Pars plana vitrectomy with ILM peeling
Eligibility Criteria
You may qualify if:
- male or female with impending macular hole(identified with OCT)
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 82-2-3010-3673, 138-736, South Korea
Konyang University, Myung Gok Eye Research Institute
Daejeon, Daejeon, 302-718, South Korea
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, 463-707, South Korea
HanGil Eye Hospital
Incheon, In Cheon, South Korea
Seoul National University Hospital
Seoul, Seoul, 110-744, South Korea
Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
Seoul, Seoul, 134-701, South Korea
Samsung Medical Center
Seoul, Seoul, 135-710, South Korea
Catholic University of Korea
Seoul, Seoul, 137-701, South Korea
Gangnam Sacred Heart Hospital,Hallym University
Seoul, Seoul, 150-950, South Korea
Kong eye clinic
Seoul, Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Se Woong Kang, M.D.
Seoul Retina Investigator Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
April 30, 2010
First Posted
May 12, 2010
Study Start
November 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2012
Last Updated
March 29, 2011
Record last verified: 2011-03