Retrospective Study on the Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens With Follow-up at 3 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Best-corrected distance visual acuity
研究概览
简要总结
The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 years or older submitted to cataract surgery with binocular implantation of Asqelio Trifocal TFLIO130C IOL
- •Seeking spectacle independence after surgery
- •IOL power between +5.0D y +34.0D
- •Transparent ocular media, except for the cataract prior to surgery.
- •Potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery
排除标准
- •Preoperatory corneal astigmatism greater than 1.0D
- •Previous corneal surgery or trauma
- •Irregular cornea (e.g. keratoconus)
- •Choroidal hemorrhage
- •Microftalmos
- •Severe corneal dystrophy
- •Uncontrolled or medically controlled glaucoma
- •Clinically significant macular changes
- •Severe concomitant ocular condition
- •Cataract not age-related
- •Severe optic nerve atrophy
- •Diabetic retinopathy
- •Extremely shallow anterior chamber
- •Severe chronic uveitis
- •Pregnancy or lactating
- •Mature/dense cataract difficulting preoperatory eye fundus assessment
- •Previous retinal detachment
- •Concurrent participation in another investigation involving drugs or medical devices
结局指标
主要结局
Best-corrected distance visual acuity
时间窗: 3 months after implantation
Best-corrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Defocus curve
时间窗: 3 months after implantation
Binocular defocus curve with best correction for distance obtained varying mergence from -4.0D to +2.0D in 0.5D steps
Uncorrected distance visual acuity
时间窗: 3 months after implantation
Uncorrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Uncorrected intermediate visual acuity
时间窗: 3 months after implantation
Uncorrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Distance-corrected near visual acuity
时间窗: 3 months after implantation
Distance-corrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Uncorrected near visual acuity
时间窗: 3 months after implantation
Uncorrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Distance-corrected intermediate visual acuity
时间窗: 3 months after implantation
Distance-corrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
次要结局
- Manifest Refraction(Preoperatively and 3 months after implantation)
- Adverse events(3 months after implantation)
- Patient-reported outcomes CATQuest9SF(3 months after implantation)
- Patient-reported outcomes PRSIQ(3 months after implantation)
- Patient-reported outcomes PRVSQ(3 months after implantation)