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

NCT04076072 | Completed Results FDA Device

• 1 other identifier: 190728
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vitrectomy

Outcome Measures

Primary Outcomes (1)

• 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 )

Other Outcomes (1)

• Number of Participants With Intraoperative Complications

  3 months

Study Arms (2)

Alcon Advanced Ultravit High-Speed Vitrectomy Probe

ACTIVE COMPARATOR

On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.

Device: Utravit High-Speed 10000 cpm Beveled Probe

Alcon Non-Beveled Tip Vitrectomy Probe

ACTIVE COMPARATOR

On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.

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

Interventions

Utravit High-Speed 10000 cpm Beveled Probe DEVICE

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.

Alcon Advanced Ultravit High-Speed Vitrectomy Probe

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

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.

Alcon Non-Beveled Tip Vitrectomy Probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous incisional intraocular surgery other than uncomplicated cataract surgery with intraocular lens placement
• Inability to consent for procedure

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Alcon Research: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Results Point of Contact

• Title: Marybeth Carter
• Organization: Vanderbilt University Medical Center

Marybeth.l.carter@vumc.org

615-936-1639

Study Officials

• Shriji N Patel, MD

  Vanderbilt Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization and data storage will occur in RedCap. Patients will be randomized the day of surgery by a masked study coordinator. The randomization numbers will be generated using the following procedure to ensure that treatment assignment is unbiased and concealed from patients and investigator staff. A patient randomization list will be produced by the IRT provider using a validated system that automates the random assignment of patient numbers to randomization numbers. These randomization numbers are linked to the different treatment arms. The randomization scheme for patients will be reviewed and approved by a member of the Randomization Group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: September 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: October 21, 2022
• Results First Posted: October 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)