Clinical Trial: Early Vitrectomy for Impending Macular Hole

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial

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 Summary:

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

Sponsor: Seoul Retina Investigator Group

Current Primary Outcome: Best Corrected Visual acuity [ Time Frame: 48 weeks ]

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Seoul Retina Investigator Group

Dates:
Date Received: April 30, 2010
Date Started: November 2009
Date Completion: November 2012
Last Updated: March 28, 2011
Last Verified: March 2011