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The objective of the study is to evaluate:
Pars plana vitrectomy (PPV) and scleral buckling (SB) are major choices in treating rhegmatogenous retinal detachment (RRD) of medium complexity. PPV is more prevailed since it improved internal search for breaks and elimination of vitreous traction. SB has unmatched advantages over PPV such as earlier rehabilitation, free from prolonged positioning, less complicated cataract or glaucoma. The novel foldable capsular scleral buckle (FCSB) can create a big bulge by pressing on the sclera and seal the break in bullous RRD without scleral drainage. In the study, differences of anatomic and functional results between PPV and FCSB in treating primary RRD of medium complexity are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FCSB | Experimental | Using foldable capsular scleral buckle surgery to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity |
|
| PPV | Active Comparator | Using pars plana vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| foldable capsular scleral buckling | Procedure | Using foldable capsular vitreous body as a novel scleral buckle material to treat the primary rhegmatogenous retinal detachment (RRD) of medium complexity |
| Measure | Description | Time Frame |
|---|---|---|
| anatomic success rate | The success rate of retinal reattachment | From enrollment to the end of treatment at 6 months |
| metamorphopsia | metamorphopsia is measured by M chart | From enrollment to the end of treatment at 6 months |
| Visual Results | Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The number of surgeries that achieved successful final retinal reattachment | The number of surgeries the patient undergoes to achieve final retinal reattachment | From enrollment to the end of treatment at 6 months |
| Surgical Complications |
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Inclusion Criteria:
One or more retinal holes which cannot be treated sufficiently with a single silicon sponge or silicone band (e.g. large holes, multiple holes, multiple holes of varying anterior-posterior localisation, massive traction)
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EyeEntFudan | Shanghai | Shanghai Municipality | 200031 | China |
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| vitrectomy | Procedure | Using vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity. |
|
Surgical Complications, included EOM dysfunction,Choroidal detachment,Clinical CME,Macular pucker,Postoperative IOP >21 mmHg with medications
| From enrollment to the end of treatment at 6 months |
| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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