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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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To investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes
The investigators aimed to compare the safety and efficacy of NGENUITY® 3D Visualization System (Alcon, TX, USA) in vitreoretinal surgery of highly myopic patients with standard binocular microscope pars plana vitrectomy of highly myopic patients. This is a randomized controlled study and will enroll highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery. The enrolled patients will be randomized into "NGENUITY® 3D Visualization System (Alcon, TX, USA) group"(trial group) and "standard binocular microscope pars plana vitrectomy group"(controlled group). The investigators will compare the number of injections of dye (indocyanine green (ICG) or brilliant blue G (BBG)), total surgical time, total peeling time, exposure time of dye, power of endoilluminator, the rate of probe bending, surgical time, postoperative intraocular pressure (IOP), the rate of wound leakage, hypotony, subconjunctival hemorrhage, vitreous hemorrhage, retinal hemorrhage, and endophthalmitis, best-corrected visual acuity (BCVA), structural changes shown on OCT and so on between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA) | Experimental | NGENUITY® 3D Visualization System (Alcon, TX, USA) |
|
| standard binocular microscope pars plana vitrectomy | Active Comparator | standard binocular microscope pars plana vitrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pars plana vitrectomy | Procedure | pars plana vitrectomy for vitreoretinal disease in highly myopic eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of injections of ICG | Fixed and minimal concentration: ICG (25mg/vial) is diluted to 0.05% Fixed time: Each injection is 15 sec Interval time for washout: consistent as 10 sec | operation day |
| Measure | Description | Time Frame |
|---|---|---|
| Total surgical time | Total surgical time | Intraoperative |
| ILM peeling time | ILM peeling time | operation day |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ho Tzyy-Chang, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
Data may be provided under reasonable request.
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| NGENUITY® 3D Visualization System (Alcon, TX, USA) | Device | Injection of ICG to stain internal limiting membrane |
|
| ICG exposure time | ICG exposure time | operation day |