VISTA OPHTHALMICS 1-STEP VITRECTOR POST MARKET LIMITED VITREOUS REMOVAL (LVR) CLINICAL ASSESSMENT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Degree of change in iTrace Dysfunctional Lens Index (DLI) from baseline to post-operative visit Day 30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Degree of change in iTrace Dysfunctional Lens Index (DLI) from baseline to post-operative visit Day 30
时间窗: Day 30 (+/- 7 days)
iTrace Dysfunctional Lens Index (DLI) score
Degree of change in Kim Floater Survey from baseline to post-operative visit Day 30
时间窗: Day 30 (+/-7 days)
Assessment using Kim Floater Questionnaire
Degree of change in surgeon assessed vitreous opacities from baseline to post-operative visit Day 30
时间窗: Day 30 (+/-7 days)
Dilated Fundus/Peripheral Exam
次要结局
- Incidence of post-operative adverse events(Day 30 (+/- 7 days))
研究者
Inder Paul Singh, M.D.
Ophthalmologist and President, The Eye Centers of Racine & Kenosha
The Eye Centers of Racine and Kenosha