A Prospective Multicenter Study of Different Surgical Methods in the Treatment of High Myopic Macular Schisis

Study Overview
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Brief Summary
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In view of the current problem of treating high myopic macular schisis, the main purpose of our study is to find out the most appropriate time of surgical intervention, to compare the effectiveness and safety of various surgical methods in the treatment of high myopic macular schisis, and to find out the advantages and disadvantages of each surgical method in the treatment of MF. As well as the outcomes and complications of long-term follow-up.

Official Title
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A Prospective Multicenter Study of Different Surgical Methods for the Treatment of Macular Schisis in High Myopia Based on the Real World

Conditions
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Macular Schisis

Intervention / Treatment
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* Procedure: PPV+/-Cat
* Procedure: PPV+/-Cat+Gas
* Procedure: PPV+ILM+/-Cat+/-Gas
* Procedure: PPV+ILM+/-Cat+/-Oil
* Procedure: PSR
* Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）
* Procedure: Gas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diopter ≤-6.00D or axial length ≥ 26.00mm; OCT showed macular schisis with or without macular retinal detachment; agreed to participate in this project and signed informed consent form. Exclusion Criteria: OCT confirmed full-thickness macular hole with or without macular retinal detachment； submacular active or inactive CNV; previous vitreoretinal surgery and anti-glaucoma surgery； with rhegmatogenous retinal detachment, ocular trauma, glaucoma, corneal opacity and other ophthalmic diseases; complicated with severe systemic disease can not tolerate surgery or follow-up; do not agree to participate the project or disagree with the follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: PPV+/-Cat<br> | Procedure: PPV+/-Cat<br>* pars plana vitrectomy+/-cataract<br>|
| Active Comparator: PPV+/-Cat+Gas<br> | Procedure: PPV+/-Cat+Gas<br>* pars plana vitrectomy+/-cataract+gas tamponade<br>|
| Active Comparator: PPV+ILM+/-Cat+/-Gas<br> | Procedure: PPV+ILM+/-Cat+/-Gas<br>* pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-gas tamponade<br>|
| Active Comparator: PPV+ILM+/-Cat+/-Oil<br> | Procedure: PPV+ILM+/-Cat+/-Oil<br>* pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade<br>|
| Active Comparator: PSR<br> | Procedure: PSR<br>* posterior scleral reinforcement<br>|
| Active Comparator: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）<br> | Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）<br>* posterior scleral reinforcement+pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade (or gas)<br>|
| Active Comparator: Gas<br> | Procedure: Gas<br>* gas tamponade alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| foveal thickness | measured by OCT | change from baseline foveal thickness at 3, 6, 9, 12 months | 
| retinal thickness of the most significant schisis | measured by OCT | change from baseline at 3, 6, 9, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity | BCVA | change from baseline at 3, 6, 9, 12 months | 
| mf-ERG | multifocal-ERG | change from baseline at 3, 6, 9, 12 months | 
| Visual quality questionnaire | Visual quality questionnaire | change from baseline at 3, 6, 9, 12 months | 
| axial length | axial length measured by IOL Master | change from baseline at 3, 6, 9, 12 months |