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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.
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-related quality of life (QoL) in some patients.
Vitrectomy is a surgical procedure to remove the vitreous humour, the transparent jelly, from inside the eye. Vitrectomy Surgery can be of two types: Full and Limited. Full Vitrectomy is the commonly used and standard technique for repairing retinal detachments, removing membranes or haemorrhages, and involves vitreous detachment from the retina and its removal, both centrally and peripherally. Limited Vitrectomy is a new technique which focuses on the removal of only the central part of the vitreous or Core with the Vitreous Opacities or "Floaters" in it, and without intentionally detaching it from the retina.
The Vista Ophthalmics vitrectomy probe is a single-use vitrector intended to perform anterior/posterior vitrectomy procedures and to remove vitreous and dissect tissue in the eye. The Vista Ophthalmic's probe is designed as a stand-alone handpiece for use with ophthalmic systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-operative adverse events | Ophthalmic examination | Day 30 (+/- 7 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Centers of Racine & Kenosha | Kenosha | Wisconsin | 53142 | United States |
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| ID | Term |
|---|---|
| C000726608 | vitreous floaters |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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.
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