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

NCT04076072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-10-21

Study results available
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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.

Conditions

  • Vitrectomy

Interventions

DEVICE

Utravit High-Speed 10000 cpm Beveled Probe

This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.

DEVICE

standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm

This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Shriji N Patel, MD · Vanderbilt Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-01-01
Completion
2022-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04076072 on ClinicalTrials.gov