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Early Vitrectomy for Impending Macular Hole

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 82-2-3010-3673, Korea, Republic of, 138-736
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, Korea, Republic of, 463-707
Konyang University, Myung Gok Eye Research Institute
Daejeon, Korea, Republic of, 302-718
HanGil Eye Hospital
In Cheon, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
Seoul, Korea, Republic of, 134-701
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Gangnam Sacred Heart Hospital,Hallym University
Seoul, Korea, Republic of, 150-950
Kong eye clinic
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul Retina Investigator Group
Investigators
Principal Investigator: Se Woong Kang, M.D. Seoul Retina Investigator Group
  More Information

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
Temazepam
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

ClinicalTrials.gov processed this record on December 09, 2016