Early Vitrectomy for Impending Macular Hole

Not Applicable

• Conditions: Retinal Perforation
• Interventions: Procedure: Pars plana vitrectomy with ILM peeling

• Registration Number: NCT01121965
• Lead Sponsor: Seoul Retina Investigator Group

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

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-28
• Last Update Posted: 2011-03-29
• Primary Completion: 2011-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early vitrectomy	Pars plana vitrectomy with ILM peeling	Pars plana vitrectomy with ILM peeling would be employed when visual symptoms occur.

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual acuity	48 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of occurrence of full-thickness macular hole	48 weeks

Trial Locations

Locations (10)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Gangnam Sacred Heart Hospital,Hallym University; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, 82-2-3010-3673, Korea, Republic of

Konyang University, Myung Gok Eye Research Institute; 🇰🇷 Daejeon, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyunggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangdong Sacred Heart Hospital, Hallym University College of Medicine,; 🇰🇷 Seoul, Korea, Republic of

Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of

Kong eye clinic; 🇰🇷 Seoul, Korea, Republic of

HanGil Eye Hospital; 🇰🇷 In Cheon, Korea, Republic of