Early Vitrectomy for Impending Macular Hole

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121965
Recruitment Status : Unknown
Verified March 2011 by Seoul Retina Investigator Group.
Recruitment status was:  Recruiting
First Posted : May 12, 2010
Last Update Posted : March 29, 2011
Information provided by:
Seoul Retina Investigator Group

Brief Summary:
This study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole.

Condition or disease Intervention/treatment Phase
Retinal Perforation Procedure: Pars plana vitrectomy with ILM peeling Not Applicable

Detailed Description:

In a study conducted 15 years ago, the 'Vitrectomy for Prevention of Macular hole Study Group' was not able to prove the benefits and advantages of vitrectomy for impending macular hole; however, during the interim period, notable improvements have been achieved with regard to diagnosis and efficacy of treatment.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial
Study Start Date : November 2009
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2012

Arm Intervention/treatment
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 occurs
Experimental: Early vitrectomy
Pars plana vitrectomy with ILM peeling would be employed when visual symptoms occur.
Procedure: Pars plana vitrectomy with ILM peeling
Pars plana vitrectomy with ILM peeling
Other Name: macular hole surgery

Primary Outcome Measures :
  1. Best Corrected Visual acuity [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Rate of occurrence of full-thickness macular hole [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121965

Contact: Se Woong Kang, M.D. 82-2-3410-3562
Contact: Se Woong Kang 82234103562

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   
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.         
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.         
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.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Se Woong Kang, M.D.    82-2-3410-3562   
Principal Investigator: Se Woong Kang, 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.         
Kong eye clinic Recruiting
Seoul, Korea, Republic of
Contact: Eun Goo Lee, M.D.    02-480-5000      
Principal Investigator: Eun Goo Lee, M.D.         
Sponsors and Collaborators
Seoul Retina Investigator Group
Principal Investigator: Se Woong Kang, M.D. Seoul Retina Investigator Group

Responsible Party: Se Woong Kang, Samsung Medical Center Identifier: NCT01121965     History of Changes
Other Study ID Numbers: SRIG #1
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: March 29, 2011
Last Verified: March 2011

Keywords provided by Seoul Retina Investigator Group:
macular hole
impending macular hole
stage 1 macular hole

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action