Early Vitrectomy for Impending Macular Hole

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Seoul Retina Investigator Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul Retina Investigator Group
ClinicalTrials.gov Identifier:
NCT01121965
First received: April 30, 2010
Last updated: March 28, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention
Retinal Perforation
Procedure: Pars plana vitrectomy with ILM peeling

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 Impending Macular Hole. 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: 60
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 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

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
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121965

Contacts
Contact: Se Woong Kang, M.D. 82-2-3410-3562 swkang@skku.edu
Contact: Se Woong Kang 82234103562 swkang@skku.edu

Locations
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    jiani4@snu.ac.kr   
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.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Se Woong Kang, M.D.    82-2-3410-3562    swkang@skku.edu   
Principal Investigator: Se Woong Kang, 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.         
Kong eye clinic Recruiting
Seoul, Korea, Republic of
Contact: Eun Goo Lee, M.D.    02-480-5000      
Principal Investigator: Eun Goo Lee, 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.         
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.         
Sponsors and Collaborators
Seoul Retina Investigator Group
Investigators
Principal Investigator: Se Woong Kang, M.D. Seoul Retina Investigator Group
  More Information

No publications provided

Responsible Party: Se Woong Kang, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01121965     History of Changes
Other Study ID Numbers: SRIG #1
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 hole
impending macular hole
stage 1 macular hole

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014