Early Vitrectomy for Macular Tractional Maculopathy

Study Overview
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Brief Summary
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This study is designed to identify the effect of current vitreous surgery for symptomatic macular tractional maculopathy. Characteristics of this study is as below Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole formation or deterioration of visual acuity occurs) Non-randomized study (decision was made by patients after full explanation) After 1 year follow up, functional change(visual acuity)and anatomical change would be evaluated

Detailed Description
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Degenerative myopia is relatively common disorder, especially in Korean, Japanese and Chinese. Choroidal neovascularization is well-noted cause of VA deterioration, but nowadays, with improvement of diagnostic tools, such as OCT, VA deterioration from myopic tractional maculopathy is being concerned as well. But till now, the necessity of early vitrectomy on MTM is controversial. By now some clinicians prefer conservative treatment, which means pars plana vitrectomy would be postponed till structural change such as macular hole formation is noticed. And the others prefer early vitrectomy, which means pars plana vitrectomy should be performed when the symptom begins. In this study, investigators try to verify the validity of early vitrectomy comparing conservative treatment.

Official Title
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Early Vitrectomy for Macular Tractional Maculopathy. Multicenter Clinical Trial

Conditions
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Myopia, Degenerative

Intervention / Treatment
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* Procedure: Early vitrectomy


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 20 years Symptom duration < 6 Months Visual acuity on trial: more than 20/320 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 Any evidence of atrophic change, scar or exudation on macula active intraocular inflammation History of intraocular surgery other than uncomplicated cataract extraction 3 months before Uncontrolled IOP > 25mmHg

Ages Eligible for Study
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Minimum Age: 20 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 or vision deterioration occurs | |
| Experimental: Early vitrectomy<br>Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling | Procedure: Early vitrectomy<br>* Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling<br>* Other names: pars plana vitrectomy for macular tractional maculopathy;|

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 tractional maculopathy, pathologic myopia