View clinical trials related to Vitrectomy.
Filter by:This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.
This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.
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.
Cataract is the opacification of the lens. Usually cataract occurs slowly, causing progressive vision loss over several months or years. In ophthalmic clinical practice, repeated objective quantitative measurements of lens opacity may be necessary to document its progression and support a surgical indication. The subjective methods of evaluating the opacification of the lens have limitations, in particular due to the lack of reproducibility between observers. Thus, innovative objective techniques with precise and reproducible cataract classification results have been developed, such as the Objective Scatter Index (OSI) on the Optical Quality Analysis System (OQAS), Visiometrics SL in 2010 and, more recently, Average Lens Density (ALD) on the IOLMaster® 700 device. Cataract is diagnosed as mature when the OSI is ≥ 2 and / or when the ALD is ≥ 74 pixel units. Vitrectomy is a surgery of the posterior segment of the eye indicated for retinal detachment, epimacular membranes, macular holes, vitreous hemorrhage. The incidence of post-vitrectomy cataract varies among studies, and the methodology is often retrospective. Age has already been identified as a risk factor for progression since in a study of 28 eyes of patients under 50 years old, only 7% developed cataracts secondarily, compared to 79% in the 'over 50' group. To date, there is no prospective study describing the progression kinetics of lens opacification according to precise and reproducible quantitative objective criteria in patients treated by vitrectomy. It also involves confirming the age and preoperative lens status as a risk factor for postoperative cataract progression.
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
To perform a safety study on the prototype IRIS vitrectomy device.
Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases
In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. However, there were still some concerns regarding small gauge vitrectomy system, especially 27-gauge system, in the stability of its instruments and the efficacy of removing vitreous during surgery. Although there were some studies that had reported the surgical outcomes of 27G vitrectomy system, none had focused on patients with high myopia. The highly myopic patients usually had thinner sclera, which was a risk factor for wound leakage after sutureless vitrectomy, they also had longer axial length which would make the surgical procedure more difficult especially in macular surgery. Based on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control. Hypothesis: The 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system
The purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.
Common complications of the Boston keratoprosthesis type 1 (KPro) surgery include retroprosthetic membrane formation, glaucoma, and retinal detachment. Often pars plana vitrectomy (PPV) is performed at the same time as KPro surgery for different indications. It has been shown to reduce postoperative complications in comparison to when it is performed after the KPro surgery. Patients who receive a complete PPV with peeling of the anterior hyaloid membrane have a lower incidence of retroprosthetic membrane formation and less vision loss due to glaucoma when compared to patients with partial PPV or anterior vitrectomy. During a complete PPV, peeling of the anterior hyaloid membrane is a difficult step because visualisation is poor, but it can be improved using endoscopy. The investigators suggest that peeling of the anterior hyaloid membrane assisted by endoscopy during KPro surgery would decrease postoperative complications in comparison to a PPV done after KPro surgery and without endoscopy.