Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In recent years, vitrectomy has moved toward a minimally invasive vitrectomy surgery (MIV) system, which could effectively reduce the occurrence of operation complications, while reducing the time of post-operation recovery.
With an improved design of bevel tip and a high cutting rate capacity of 10000cpm, Advanced ULTRAVIT® probes potentially provide an strong technical support for the application of MIV. The new probe facilitates great control during delicate surgical maneuvers, such as separating the hyaloid from the retinal surface, dissecting fibrovascular tissue off the surface of retina.
However, there was no sufficient clinical evidence to support the benefits of Advanced ULTRAVIT ® probes in the complicated vitreoretinal surgery, such as proliferative diabetic retinopathy. More importantly, there is an urgent need of clinical evidence to support 10000cpm launch and conversion which is major objective of 2021 VR growth strategies.
This exploratory study, aiming to demonstrate the beneficial of 27 Gauge probe, which can be flexibly applied as a multifunctional tool for membrane removal by reducing frequencies of switching device, reducing the traction to eyeball during device entering and leaving the eye. Moreover, the outcomes from this study would be an strong evidence to support further comparative study to comprehensively demonstrate the superior function compare to current heavily used 5K 25 gauge probe.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| beveled 27G+ group | Experimental | The group of patients underwent vitrectomy with a beveled 27G+ vitrectomy system. |
|
| 25G+ group | Active Comparator | The group of patients underwent vitrectomy with a standard 25G+ vitrectomy system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beveled 27G+ vitrectomy system | Device | The device is a novel 27G+ vitrectomy system, whose probe tip is beveled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the convenience in operating | The convenience will be indicated by times of ancillary instrument using, which evaluated based on the recorded surgical video. | during surgery |
| the efficiency of stripping membrane | It will be measured by the area of membrane removed per minute by probe. | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| best corrected visual acuity (BCVA) | BCVA using a logMAR visual acuity chart method | baseline to 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| intra-surgery complications | The complications include hemorrhage, iatrogenic retinal breaks, iatrogenic cataracts and occurrence of hypotony during the surgery. They can be detected by a microscope during surgery. | during surgery |
| Post-operative complications |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Li | Tianjin Medical University Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Eye Hospital | Tianjin | 300386 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| standard 25G+ vitrectomy system | Device | The device is a traditional instrument, and its probe tip is flat. |
|
The complications include recurrent vitreous hemorrhage, retinal detachment, re-operation and ocular hypertension. They can be detected through ophthalmoscope, fundus image, B ultrasound, ophthalmotonometer and so on. |
| within 6 months after surgery |