5710458
Last Update Posted: 2023-02-02
Recruiting has ended
All Genders accepted | 18 Years + |
72 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
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.
In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.
Eligibility
Relevant conditions:
Vitrectomy
Epiretinal Membrane
Macular Hole
Vitreous Hemorrhage
Retinal Detachment
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov