A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Complete Capsulotomy
研究概览
简要总结
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification.
详细描述
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification to evaluate safety and effectiveness. The primary effectiveness endpoint is a complete capsulotomy in at least 95 percent of the cases. The primary safety endpoint is posterior capsular rupture and virtuous loss in 4 percent or less of the subjects. Other parameters to be captured during the study include anterior capsule tears, corneal touch, capsulotomy diameter, contraption of the Zepto capsulotomy, size of the corneal incision pre and post Zepto, interocular lens contraption and evaluation of zonular stability and the incidence and severity of adverse events. The criteria for patient success will be accessed based on the successful completion of a 360 degree capsulotomy without tissue bridges and no posterior capsule rupture and vitreous loss. The criteria for study success will be accessed based on a greater than or equal to 95 percent of the cases having a complete 360 degree capsulotomy without tissue bridges and less than 4 percent of subjects with posterior capsule rupture and vitreous loss.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be age 22 or older,
- •Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age related lens cataract, and then electing to undergo ZeptoTM capsulotomy,
- •Subjects must be willing and able to return for scheduled treatment and follow-up examinations for 3 months.
排除标准
- •Disease or pathology in the treatment eye that will compromise visual performance or refractive outcome (e.g. previous refractive surgery),
- •Zonular abnormality,
- •Posterior polar cataract,
- •Fellow eye with acuity less than 20/200,
- •Any prior ocular surgery of the study eye,
- •Pupillary dilation during the pre-operative exam of less than 7 mm in diameter,
- •Proliferative diabetic retinopathy,
- •Disorders of the ocular muscles, such as nystagmus or strabismus,
- •Chronic uveitis,
- •Abnormal corneal endothelium,
- •Subjects on medications with, in the opinion of the surgeon, significant ocular side effects,
- •Pregnant or nursing (lactating) women,
- •Implanted ocular device or drug in the study eye,
- •Any other condition, which in the judgment of the investigator would prevent the subject from completing the study (e.g. documented diagnosis or treatment for symptoms associated with dementia, mental illness),
- •Current participation in another drug or device clinical study, or participation in such a clinical study within the six months.
研究组 & 干预措施
Zepto Capsulotomy
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)
干预措施: Zepto System (Device)
结局指标
主要结局
Complete Capsulotomy
时间窗: During surgery
A successful complete Zepto capsulotomy is defined in this protocol to be one that results in a complete 360 degree capsulotomy without any residual tissue bridges visible to the surgeon. If there are such tissue bridges, the surgeon completes the capsulotomy manually. The primary effectiveness endpoint was defined as :Complete capsulotomy (target ≥ 95% of cases).
次要结局
未报告次要终点