NCT01121965

Early Vitrectomy for Impending Macular Hole

Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Seoul Retina Investigator Group · Network
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Retinal Perforation

Interventions

Type	Name	Description
PROCEDURE	Pars plana vitrectomy with ILM peeling	Pars plana vitrectomy with ILM peeling

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-11-01
• Completion: 2012-11-01
• First posted: 2010-05-12
• Last updated: 2011-03-29

Locations

10 sites across 1 country: South Korea