N/A N=40 Randomized Triple-blind Health Services Research

Beveled-Tip Versus(vs) Standard-Tip Vitrectomy Probe

Vitrectomy

Bottom Line

View on ClinicalTrials.gov: NCT04076072 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Time to Completion of Core Vitrectomy and Shave of Vitreous Base — 9.7; 10.4 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Utravit High-Speed 10000 cpm Beveled Probe (Device); standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Completion of Core Vitrectomy and Shave of Vitreous Base	9.7; 10.4	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04076072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.