Vitrectomy Clinical Trial
Official title:
High-speed Beveled Tip Versus Standard Tip Vitrectomy Probe: a Prospective Randomized Clinical Trial
Verified date | September 2022 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the efficiency of the new Utravit High-Speed 10000 cpm Beveled Probe to the current standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm. Study Design: This is a randomized controlled trial comparing the efficiency of the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery. Hypothesis: The Advanced Ultravit high-speed beveled probe will show non-inferiority to the standard, Alcon (non-beveled) Ultravit 7500 cpm with regards to time to completion of vitrectomy and surgical outcomes.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - The study population will be male and female patients 18 years old or older with the presence of pathology requiring routine vitreoretinal surgery (vitreous opacities, vitreous hemorrhage, vitreomacular traction, macular hole, epiretinal membrane) without previous history of vitreoretinal surgery. Ability to consent to procedure. Exclusion Criteria: - Previous incisional intraocular surgery other than uncomplicated cataract surgery with intraocular lens placement - Inability to consent for procedure |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Intraoperative Complications | Participants in each study arm experiencing intraoperative complications (e.g. iatrogenic retinal breaks, intraocular bleeding, retinal detachment) | 3 months | |
Primary | Time to Completion of Core Vitrectomy and Shave of Vitreous Base | Intraoperative efficiency of vitrectomy surgery regarding time to completion of core vitrectomy and shave of vitreous base | Time to completion of core vitrectomy and shave of vitreous base (12 ± 3 minutes ) |
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