Recovery: A Prospective Multicenter Study of Different Surgical Methods in the Treatment of High Myopic Macular Schisis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control
|
|
| Active Comparator: PPV+/-Cat
|
Procedure: PPV+/-Cat
pars plana vitrectomy+/-cataract
|
| Active Comparator: PPV+/-Cat+Gas
|
Procedure: PPV+/-Cat+Gas
pars plana vitrectomy+/-cataract+gas tamponade
|
| Active Comparator: PPV+ILM+/-Cat+/-Gas
|
Procedure: PPV+ILM+/-Cat+/-Gas
pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-gas tamponade
|
| Active Comparator: PPV+ILM+/-Cat+/-Oil
|
Procedure: PPV+ILM+/-Cat+/-Oil
pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade
|
| Active Comparator: PSR
|
Procedure: PSR
posterior scleral reinforcement
|
| Active Comparator: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）
|
Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）
posterior scleral reinforcement+pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade (or gas)
|
| Active Comparator: Gas
|
Procedure: Gas
gas tamponade alone
|
Outcome Measures
Primary Outcome Measures
- foveal thickness [change from baseline foveal thickness at 3, 6, 9, 12 months]
measured by OCT
- retinal thickness of the most significant schisis [change from baseline at 3, 6, 9, 12 months]
measured by OCT
Secondary Outcome Measures
- best corrected visual acuity [change from baseline at 3, 6, 9, 12 months]
BCVA
- mf-ERG [change from baseline at 3, 6, 9, 12 months]
multifocal-ERG
- Visual quality questionnaire [change from baseline at 3, 6, 9, 12 months]
Visual quality questionnaire
- axial length [change from baseline at 3, 6, 9, 12 months]
axial length measured by IOL Master
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Aier Eye Hospital | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Aier School of Ophthalmology, Central South University
Investigators
- Study Chair: Weisheng Li, Shanghai Aier Eye Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- AM1901D3