Status:
COMPLETED
EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE
Lead Sponsor:
The Eye Centers of Racine and Kenosha
Conditions:
Vitreous Floaters
Vitreous Opacities
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Vitreous opacities or floaters are a common ocular condition that seems ubiquitous in a retina practice. Although symptoms are minimal in most patients, they can cause significant impairment in vision...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07140692
Start Date
September 14 2023
End Date
July 1 2024
Last Update
August 25 2025
Active Locations (1)
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1
The Eye Centers of Racine & Kenosha
Kenosha, Wisconsin, United States, 53142