Early Vitrectomy for Impending Macular Hole

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

Detailed Description
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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

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

Conditions
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Retinal Perforation

Intervention / Treatment
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* Procedure: Pars plana vitrectomy with ILM peeling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conservative treatment group<br>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<br>Pars plana vitrectomy with ILM peeling would be employed when visual symptoms occur. | Procedure: Pars plana vitrectomy with ILM peeling<br>* Pars plana vitrectomy with ILM peeling<br>* Other names: macular hole surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual acuity |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of occurrence of full-thickness macular hole |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular hole, impending macular hole, stage 1 macular hole