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Completed

NCT Number: NCT05689333

A Study to Evaluate the Safety and Performance of the Vista Probe for Vitrectomy Surgery

This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CBCC Global Research Site:003, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participant with age ≥ 18 years at the time of screening.
  • Subject must have a clinical indication for anterior vitrectomy.
  • Subjects must be able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
  • Subjects must be willing and able to comply with all treatment and follow-up study procedures.

Exclusion criteria

  • Subjects who have experienced any significant trauma in the operative eye within the past month.
  • Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.
  • Subjects with prior history of uncontrolled glaucoma or uveitis refractory to treatment or ocular hypertension (IOP>30mm Hg) in study eye.
  • Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigator's medical judgment, poses a concern for the subjects' safety.
  • Female subjects of child bearing potential with positive urine pregnancy test
  • Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into or during this study.

Treatment and study plan

Vista Vitrectomy Probe

Device

Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector

Primary outcomes

  1. Incidence of post-operative rates of retinal tears

    Time frame: Month 1

    Calculate the incidence of post-operative rates of retinal tears

  2. Incidence of retinal detachment

    Time frame: Month 1

    Calculate the incidence of post-operative retinal detachment

  3. Incidence of sclerotomy complications like leakage

    Time frame: Month 1

    Calculate the incidence of post-operative sclerotomy complications like leakage

  4. Incidence of ocular hypotony

    Time frame: Month 1

    Calculate the incidence of post-operative ocular hypotony

  5. Incidence of choroidal detachment

    Time frame: Month 1

    Calculate the incidence of post-operative choroidal detachment

  6. Incidence of visually significant vitreous hemorrhage

    Time frame: Month 1

    Calculate the incidence of post-operative visually significant vitreous hemorrhage (visual acuity defined by counting fingers or worse)

  7. Incidence of endophthalmitis

    Time frame: Month 1

    Calculate the incidence of post-operative endophthalmitis

Secondary outcomes

  1. Surgeon- will assess device adequacy for removal of vitreous

    Time frame: Day 0 (Operative Visit)

    Surgeon-assess device adequacy for removal of vitreous will be summarized using counts and percentages

  2. Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking

    Time frame: Days1, 7, 30 & 90

    Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking, at any post-operative visit will be summarized using counts and percentages

Sponsors and collaborators

Lead sponsor

VISTA Ophthalmics

Industry

Collaborators

  • CBCC Global Research

Registry information

Official study title

A Prospective, Single-arm, Non-comparative, Open-label, Monocular, Post Approval Study to Assess Safety and Device Performance of the Vista Vitrectomy Probe During Vitrectomy Surgery

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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