EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE (NCT07140692) | Clinical Trial Compass
CompletedNot Applicable
EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE
United States40 participantsStarted 2023-09-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Degree of change in iTrace Dysfunctional Lens Index (DLI) from baseline to post-operative visit Day 30
Timeframe: Day 30 (+/- 7 days)
2
Degree of change in Kim Floater Survey from baseline to post-operative visit Day 30
Timeframe: Day 30 (+/-7 days)
3
Degree of change in surgeon assessed vitreous opacities from baseline to post-operative visit Day 30