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Early Vitrectomy for Impending Macular Hole

Primary Purpose

Retinal Perforation

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pars plana vitrectomy with ILM peeling
Sponsored by
Seoul Retina Investigator Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Perforation focused on measuring macular hole, impending macular hole, stage 1 macular hole

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center, University of Ulsan College of MedicineRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Konyang University, Myung Gok Eye Research InstituteRecruiting
  • HanGil Eye HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Kangdong Sacred Heart Hospital, Hallym University College of Medicine,Recruiting
  • Samsung Medical CenterRecruiting
  • Catholic University of KoreaRecruiting
  • Gangnam Sacred Heart Hospital,Hallym UniversityRecruiting
  • Kong eye clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conservative treatment group

Early vitrectomy

Arm Description

Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs

Pars plana vitrectomy with ILM peeling would be employed when visual symptoms occur.

Outcomes

Primary Outcome Measures

Best Corrected Visual acuity

Secondary Outcome Measures

Rate of occurrence of full-thickness macular hole

Full Information

First Posted
April 30, 2010
Last Updated
March 28, 2011
Sponsor
Seoul Retina Investigator Group
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1. Study Identification

Unique Protocol Identification Number
NCT01121965
Brief Title
Early Vitrectomy for Impending Macular Hole
Official Title
Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul Retina Investigator Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Perforation
Keywords
macular hole, impending macular hole, stage 1 macular hole

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative treatment group
Arm Type
No Intervention
Arm Description
Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs
Arm Title
Early vitrectomy
Arm Type
Experimental
Arm Description
Pars plana vitrectomy with ILM peeling would be employed when visual symptoms occur.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy with ILM peeling
Other Intervention Name(s)
macular hole surgery
Intervention Description
Pars plana vitrectomy with ILM peeling
Primary Outcome Measure Information:
Title
Best Corrected Visual acuity
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Rate of occurrence of full-thickness macular hole
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Se Woong Kang, M.D.
Phone
82-2-3410-3562
Email
swkang@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Se Woong Kang
Phone
82234103562
Email
swkang@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, M.D.
Organizational Affiliation
Seoul Retina Investigator Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
State/Province
82-2-3010-3673
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Hee Yoon, M.D.
Phone
82-2-3010-3673
First Name & Middle Initial & Last Name & Degree
Young Hee Yoon, M.D.
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyunggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyu Hyung Park, M.D
Phone
82-31-787-7373
Email
jiani4@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Kyu Hyung Park, M.D
Facility Name
Konyang University, Myung Gok Eye Research Institute
City
Daejeon
ZIP/Postal Code
302-718
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Woo Kim, M.D.
Phone
82-42-600-8816
First Name & Middle Initial & Last Name & Degree
Jong Woo Kim, M.D.
Facility Name
HanGil Eye Hospital
City
In Cheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joonhong Sohn, M.D.
Phone
0325033322
First Name & Middle Initial & Last Name & Degree
Joonhong Sohn, M.D.
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hum Chung, M.D.
Phone
82-2-2072-2437
First Name & Middle Initial & Last Name & Degree
Hum Chung, M.D.
Facility Name
Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Pyo Park, M.D.
Phone
82-2-2224-2274
First Name & Middle Initial & Last Name & Degree
Sung Pyo Park, M.D.
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, M.D.
Phone
82-2-3410-3562
Email
swkang@skku.edu
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, M.D.
Facility Name
Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won-Ki Lee, M.D.
Phone
82-2-2258-2846
First Name & Middle Initial & Last Name & Degree
Won-Ki Lee, M.D.
Facility Name
Gangnam Sacred Heart Hospital,Hallym University
City
Seoul
ZIP/Postal Code
150-950
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ha Kyoung Kim, M.D.
Phone
82-2-829-5193
First Name & Middle Initial & Last Name & Degree
Ha Kyoung Kim, M.D.
Facility Name
Kong eye clinic
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Goo Lee, M.D.
Phone
02-480-5000
First Name & Middle Initial & Last Name & Degree
Eun Goo Lee, M.D.

12. IPD Sharing Statement

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Early Vitrectomy for Impending Macular Hole

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