Prospective, post-marketing, comparative, randomized, parallel, single blind clinical study of two Ophthalmic Surgical Knives to assess clinical performance and safety in patients undergoing cataract surgery.
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- The mean performance of both ophthalmic knives will be
研究概览
简要总结
Purpose of the study is to assess clinical performance, efficacy and safety of a device when used in accordance with its approved labelling. These may examine issues such as medium-term performance, the appearance of clinical events, events specific to defined patient populations, or the performance of the device in a more representative population of providers and patients with cataract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 year or greater
- •Cataract of any kind
- •Patient willing to participate and sign informed consent to participate in study and to use device related data for scientific purpose
- •Patient willing to come for all post-operative follow-up
- •Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
排除标准
- •Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs [oral/ injectable corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection
- •Traumatic cataract
- •Pregnancy (as stated by patient) or lactation
- •Concurrent participation in another drug or device investigation.
- •Patient receiving chloroquine treatment
- •Subjects with any systemic and metabolic disease that could increase operative risk or confound the outcome
- •Vulnerable subjects
- •Patient having Microphthalmia
- •Patient having chronic uveitis
- •Patient suffering from Corneal dystrophy or endothelial insufficiency
- •Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma)
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
- •Patient who sensitive or allergic to metals.
结局指标
主要结局
The mean performance of both ophthalmic knives will be
时间窗: Intra-Operative, Post-Operative | day 1 & day 30.
evaluated by overall surgeon satisfaction score in terms of
时间窗: Intra-Operative, Post-Operative | day 1 & day 30.
following parameters [Time Frame: Intra-Operative]
时间窗: Intra-Operative, Post-Operative | day 1 & day 30.
The sharpness of blade, ease of handling the blade, smoothness of
时间窗: Intra-Operative, Post-Operative | day 1 & day 30.
incision creation, control while creating the wound.
时间窗: Intra-Operative, Post-Operative | day 1 & day 30.
次要结局
- 1) Wound integrity(2) Incision size accuracy)