Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Corneal Incision Size
研究概览
简要总结
The goal of this observational study is to evaluate whether different intraocular lens (IOL) injectors affect surgical outcomes in patients aged 40 and older undergoing cataract surgery. The main questions it aims to answer are:
- Do different IOL injectors change the size of the corneal incision during surgery?
- Do the injectors lead to different rates of complications during or after surgery? Researchers will compare the use of three different IOL injectors: two preloaded models (pioli™ and pioli™ Plus) and one manually loaded model (lioli™), to see if the preloaded systems improve surgical results compared to the manual one.
Participants will:
- Undergo routine cataract surgery using one of the three injectors, randomly assigned.
- Have measurements taken before and after surgery (e.g., vision tests, corneal incision size).
- Be monitored for any side effects or complications during and after the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older
- •Scheduled for cataract surgery using phacoemulsification technique
- •Planned implantation of an Asqelio™ monofocal intraocular lens (IOL)
- •Clear intraocular media, except for the presence of cataract (i.e., no other significant ocular opacities)
排除标准
- •Preoperative corneal astigmatism > 1.0 diopter (D)
- •Previous corneal surgery or history of ocular trauma
- •Irregular cornea (e.g., keratoconus)
- •Choroidal hemorrhage
- •Microphthalmos
- •Severe corneal dystrophy
- •Uncontrolled or medically controlled glaucoma
- •Clinically significant macular changes
- •Severe concomitant ocular disease
- •Cataract not related to aging
- •Severe optic nerve atrophy
- •Diabetic retinopathy
- •Proliferative diabetic retinopathy
- •Amblyopia
- •Extremely shallow anterior chamber
- •Severe chronic uveitis
- •Pregnant or breastfeeding
- •Mature or dense cataracts that prevent preoperative retinal examination
- •History of retinal detachment
- •Concurrent participation in another drug or medical device clinical study
结局指标
主要结局
Change in Corneal Incision Size
时间窗: Day of surgery (intraoperative)
Measurement of the corneal incision before and after intraocular lens (IOL) insertion using each type of injector. Difference in incision size (in mm)
Incidence of Adverse Events
时间窗: From surgical incision to end of surgery, assessed up to 120 minutes (intraoperative), and From end of surgery until postoperative day 30 (postoperative)
Number and type of ocular and non-ocular adverse events (serious and non-serious) recorded from initiation of the intra-ocular lens (IOL) implantation, both intraoperative and early postoperative period (up to 30 days). Percentage of participants with any AE
次要结局
- Procedure Duration(During surgery)