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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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Randomized, prospective, descriptive and comparative clinical study. The comparison is between a group of patients affected by macular pucker or macular hole, whose macular peeling is performed using a traditional optical microscope (Leica F40) - control arm, and a group of patients affected by macular pucker or macular hole whose macular peeling is performed by 3D heads-up microscopy system (NGenuity 3D, Alcon) - experimental arm.
It is a blind study for both the operator that collects data and for the statistician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Active Comparator | patients affected by macular pucker or macular hole, whose internal limiting membrane peeling is performed using a traditional optical microscope (Leica F40) |
|
| Experimental arm | Experimental | patients affected by macular pucker or macular hole whose internal limiting membrane peeling is performed by 3D heads-up microscopy system (NGenuity 3D) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macular surgery with NGENUITY surgical display system | Device | Patient undergoes VR surgery with visualization using heads up display 3D monitor viewed by the operating surgeon |
|
| Measure | Description | Time Frame |
|---|---|---|
| SANFL detection | Post-surgical analysis of SANFL (Swelling of the Arcuate Nerve Fiber Layer) measured on infrared, blue auto-fluorescence images and OCT images of peripapillary region | 2 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative time | Mean duration of the surgical procedure | during surgery |
| ILM staining | Number of internal limiting membrane staining procedures necessary |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Maria della Misericordia Hospital | Rovigo | 45100 | Italy |
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Dual-arm, pilot, randomized, prospective, descriptive and comparative clinical study
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| Macular surgery with standard operating microscope | Device | Patient undergoes VR surgery with visualization using standard operating microscope |
|
| during surgery |
| ILM grasping | Number of ILM grasping attempts. | during surgery |
| Light | Lumen of light used | during surgery |
| Surgeon ergonomics | Number of episodes of both back and neck pain | during surgery |
| BCVA | Best Corrected Visual Acuity | baseline, 1 month and 3 months after surgery |
| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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