Proliferative Diabetic Retinopathy, Vitrectomy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEbeveled 27G+ vitrectomy system
The device is a novel 27G+ vitrectomy system, whose probe tip is beveled.
DEVICEstandard 25G+ vitrectomy system
The device is a traditional instrument, and its probe tip is flat.
Sponsors
Tianjin Medical University Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients with vitreous hemorrhage and tractional retinal detachment (TRD) confirmed by fundus image and B ultrasound examination, consistent with the diagnosis of severe proliferated diabetic retinopathy (PDR). 2. Patient that could follow up postoperatively at the clinic for 6 months more. 3. All the surgeries were performed by one well-experienced retinal surgeon.
Exclusion criteria
1. Corneal lesions affecting operative field, such as corneal opacity or scar; History of vitreoretinal surgery; 2. External eye infections; 3. History of systemic thromboembolism; 4. Uncontrolled hypertension or hyperglycemia; 5. Coagulation abnormalities or currently using anticoagulant drugs other than aspirin; 6. Unable to meet postoperative position requirements; 7. Unable to be followed up regularly.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the convenience in operating | during surgery | The convenience will be indicated by times of ancillary instrument using, which evaluated based on the recorded surgical video. |
| the efficiency of stripping membrane | during surgery | It will be measured by the area of membrane removed per minute by probe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| best corrected visual acuity (BCVA) | baseline to 6 months post-surgery | BCVA using a logMAR visual acuity chart method |
Other
| Measure | Time frame | Description |
|---|---|---|
| intra-surgery complications | during surgery | 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. |
| Post-operative complications | within 6 months after surgery | 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. |
Countries
China
Outcome results
None listed