Early Vitrectomy for Impending Macular Hole

March 28, 2011 updated by: Seoul Retina Investigator Group

Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Se Woong Kang, M.D.
  • Phone Number: 82-2-3410-3562
  • Email: swkang@skku.edu

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 302-718
        • Recruiting
        • Konyang University, Myung Gok Eye Research Institute
        • Contact:
          • Jong Woo Kim, M.D.
          • Phone Number: 82-42-600-8816
        • Principal Investigator:
          • Jong Woo Kim, M.D.
      • In Cheon, Korea, Republic of
        • Recruiting
        • HanGil Eye Hospital
        • Contact:
          • Joonhong Sohn, M.D.
          • Phone Number: 0325033322
        • Principal Investigator:
          • Joonhong Sohn, M.D.
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Hum Chung, M.D.
          • Phone Number: 82-2-2072-2437
        • Principal Investigator:
          • Hum Chung, M.D.
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Se Woong Kang, M.D.
      • Seoul, Korea, Republic of, 134-701
        • Recruiting
        • Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
        • Contact:
          • Sung Pyo Park, M.D.
          • Phone Number: 82-2-2224-2274
        • Principal Investigator:
          • Sung Pyo Park, M.D.
      • Seoul, Korea, Republic of, 137-701
        • Recruiting
        • Catholic University of Korea
        • Contact:
          • Won-Ki Lee, M.D.
          • Phone Number: 82-2-2258-2846
        • Principal Investigator:
          • Won-Ki Lee, M.D.
      • Seoul, Korea, Republic of, 150-950
        • Recruiting
        • Gangnam Sacred Heart Hospital,Hallym University
        • Contact:
          • Ha Kyoung Kim, M.D.
          • Phone Number: 82-2-829-5193
        • Principal Investigator:
          • Ha Kyoung Kim, M.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Kong eye clinic
        • Contact:
          • Eun Goo Lee, M.D.
          • Phone Number: 02-480-5000
        • Principal Investigator:
          • Eun Goo Lee, M.D.
    • 82-2-3010-3673
      • Seoul, 82-2-3010-3673, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center, University of Ulsan College of Medicine
        • Contact:
          • Young Hee Yoon, M.D.
          • Phone Number: 82-2-3010-3673
        • Principal Investigator:
          • Young Hee Yoon, M.D.
    • Gyunggi-do
      • Seongnam, Gyunggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Kyu Hyung Park, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • macular hole surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual acuity
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of occurrence of full-thickness macular hole
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul Retina Investigator Group

Investigators

  • Principal Investigator: Se Woong Kang, M.D., Seoul Retina Investigator Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

April 30, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 29, 2011

Last Update Submitted That Met QC Criteria

March 28, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRIG #1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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