EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE

NCT07140692 | Completed FDA Device

• 1 other identifier: ECRK-LVR-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Vitreous opacities or floaters are a common ocular condition that can cause significant impairment in vision-related quality of life (QoL) in some patients. Vitrectomy involves the surgical removal of vitreous humour, the transparent jelly, from inside the eye that contains vitreous opacities and floaters. The present post-market clinical assessment study aims to assess the safety and effectiveness performance of the Vista 1-Step vitrectomy probe in adult pseudophakic patients with visually symptomatic opacities.

Conditions

Vitreous Floaters; Vitreous Opacities

Keywords

Vitrectomy; Vista 1-Step Vitrector; Vitreous opacities or floaters

Outcome Measures

Primary Outcomes (3)

• Degree of change in iTrace Dysfunctional Lens Index (DLI) from baseline to post-operative visit Day 30

  iTrace Dysfunctional Lens Index (DLI) score

  Day 30 (+/- 7 days)

• Degree of change in Kim Floater Survey from baseline to post-operative visit Day 30

  Assessment using Kim Floater Questionnaire

  Day 30 (+/-7 days)

• Degree of change in surgeon assessed vitreous opacities from baseline to post-operative visit Day 30

  Dilated Fundus/Peripheral Exam

  Day 30 (+/-7 days)

Secondary Outcomes (1)

• Incidence of post-operative adverse events

  Day 30 (+/- 7 days)

Study Arms (1)

Vista Ophthalmics vitrectomy

EXPERIMENTAL

In this single-arm, non-comparative study, patients presenting with vitreous opacities affecting daily activities of living will undergo vitrectomy using the single-use vitrector probe of Vista Ophthalmics for the removal of the vitreous opacities.

Device: Vitrectomy

Interventions

Vitrectomy DEVICE

In this single-arm, non-comparative study, patients presenting with vitreous opacities affecting daily activities of living will undergo vitrectomy using the single-use vitrector probe of Vista Ophthalmics for the removal of the vitreous opacities.

Vista Ophthalmics vitrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participant with age ≥ 18 years at the time of screening.
• Subjects with Posterior chamber Intraocular lens (PCIOL) in one or both the eyes (both eyes will be independently assessed).
• 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.
• Complaints of decreased vision/decreased quality of vision due to vitreous floaters which is having an impact on Activities of daily living (ADLs).
• Documentation of vitreous opacities on Slit lamp exam/Dilated Fundus Exam (SLE/DFE).
• Documentation of decreased DLI on iTrace.

You may not qualify if:

• Subjects with history of retinal tear/detachment, macular edema, Epi-retinal membrane (ERM), vitreomacular traction syndrome (VMT), Age-related macular degeneration (AMD), Proliferative Diabetic Retinopathy (PDR), or other significant retinal disorders in procedural eye.
• Subjects with History of trauma to operative eye.
• Subjects with bleeding disorders or anticoagulation.
• Subjects with history of ocular herpetic infections.
• 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.
• Any medical condition that would be contraindicated for cataract surgery.

Sponsors & Collaborators

• The Eye Centers of Racine and Kenosha: lead

Study Sites (1)

The Eye Centers of Racine & Kenosha

Kenosha, Wisconsin, 53142, United States

Location

MeSH Terms

Conditions

vitreous floaters

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist and President, The Eye Centers of Racine & Kenosha

Model Details: The Vista Ophthalmics 1-Step Vitrector is intended to perform anterior/posterior vitrectomy procedures and remove vitreous and dissected tissue in the eye. It consists of a single-use vitrector with air supply tubing.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 25, 2025
• Study Start: September 14, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 25, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)