Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
Cataract surgery is one of the most frequent surgeries carried out in the world. After cataract extraction an intraocular lens (IOL) is implanted in order to compensate for the crystalline lens power and correct patient's vision. In order to allow cataract extraction and IOL insertion, during the surgery a small incision is performed by the surgeon. This incision is performed using surgical knives, and a smaller incisión is associated with less postoperatory inflammation, faster corneal wound healing, and faster visual recovery. Several studies reported the importance of smaller incisions to reduce the risk of surgically induced astigmatism.
In order to implant the IOL through this small incision, the IOL must be preloaded in a injector that allows introducing the IOL eficiently and consistently. The manual injector BIOLI manufactured by AST Products (model D), CE approved, is designed specifically to allow the IOL insertion safely, precisely, and controllably. Among the main characteristics of this delivery system is its design to minimize the incision size widening while inserting the IOL.
The present retrospective study aims to provide more information with regards to the clinical efficacy of the BIOLI-D delivery system for the implantation of the trifocal Asqelio TFLIO130C IOL in patients submitted to cataract surgery. This will be assessed by analyzing the change in incision size after IOL implantation and the incidence of adverse events during and after the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 50 years or older submitted to cataract surgery and implanted with Asqelio trifocal TFLIO130C IOL using the BIOLI-D delivery system.
- •Patients submitted to bilateral cataract surgery.
- •Transparent ocular media, other than the bilateral cataract.
排除标准
- •Preoperatory corneal astigmatism greater than 0.75D
- •Corneal surgery or trauma prior to cataract surgery Irregular cornea
- •Choroidal hemorrhage
- •Microftalmos Severe corneal dystrophy
- •Uncontrolled or medically controlled glaucoma
- •Clinically significant macular changes
- •Concomitant ocular disease
- •Not age-related cataract
- •Severe optic nerve atrophy
- •Diabetic retinopathy
- •Proliferative diabetic retinopathy
- •Amblyopia
- •Extremelly shallow anterior chamber
- •Severe chronic uveitis
- •Mature/dense cataract difficulting fundas assessment preoperatively
- •Prior retinal detachment
- •Concurrent participation in another investigation with medication or clinical devices
结局指标
主要结局
Adverse events
时间窗: During or after the surgical procedure
Incidence of adverse events related to the use of the device, coded according to the Medical Dictionary for Regulatory Activities, and analyzed per eye (ocular), and per subject (non ocular)
Incision size before IOL implantation
时间窗: Immediately after phacoemulsification is complete
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Incision size after incision
时间窗: Immediately after clear incision is performed
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Incision size after IOL implantation
时间窗: Immediately after IOL implantation
Determined using a Capsulorhexis Incision Gauge Set, in mm.
次要结局
- Cataract grading(Before surgery)
- Refractive error PreOp(Before surgery)
- Best corrected visual acuity(One month after surgery)
- Refractive error PostOp(One month after surgery)
- Intraocular Pressure (IOP)(Before surgery)