In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens. Two-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of Posterior capsular opacity
研究概览
简要总结
This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL.
详细描述
This study is a two-arm masked clinical evaluation study of incidence of PCO after successful bilateral cataract surgery with implantation of a monofocal IOL. Subjects will be assessed 24 months after IOL implantation. Clinical evaluations will include incidence of adverse events, patient satisfaction questionnaire, as well as measurements of visual performance, optical quality, presence and intensity of PCO, presence and intensity of IOL glistening.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 22 years or older submitted to cataract surgery in at least 1 eye and implanted with Asqelio monofocal or Clareon monofocal IOL
排除标准
- •Any pathology reducing potential best-corrected visual acuity beyond 0.30 LogMAR, including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely shallow anterior chamber, microphthalmos, retinal detachment, severe recurrent anterior or posterior segment inflammation of unknown ethiology, iris neovascularization, uncontrolled glaucoma, clinically significant macular degeneration, or pseudoexfoliation diagnosis.
- •Previous ocular surgery
- •Surgery motivated by traumatic cataract
- •Ocular trauma or refractive surgery
- •Any other systemic or ocular condition that, in the investigator's opinion, should exclude the subject from study
- •Requiring additional procedures due to intraoperatory complications, mechanical or surgical interventions for manipulating the pupil, excessive iris movility, significant vitreous loss, significant, anterior chamber hyphema, capsular annular breakage, or any other unrecognized ocular conditions that might compromise IOL positioning, as well as impossibility of locate the IOL in the capsular bag due to surgical complications.
结局指标
主要结局
Incidence of Posterior capsular opacity
时间窗: 24 months after IOL implantation
Incidence of PCO
Intensity of Posterior capsular opacity
时间窗: 24 months after IOL implantation
Intensity of PCO determined using LOCSIII Classification System
次要结局
- Optical quality(24 months after IOL implantation)
- Refraction(1 month, 6 months, 12 months and 24 months after IOL implantation)
- Intensity of Glistening(24 months after IOL implantation)
- Visual acuity(1 month, 6 months, 12 months and 24 months after IOL implantation)
- Incidence of Glistening(24 months after IOL implantation)