Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SIFI SpA
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Subjective Refraction
研究概览
简要总结
The study objective is to evaluate the visual performance of MINI WELL Ready at 24 months following the second eye implant. The objectives of safety are to evaluate the rate of Secondary Surgical Interventions related to the optical properties of the IOL for first and second operative eye separately at 24 months and the rate of visual disturbances and distortions as reported by the subjects as detected by using the Halo & Glare Simulator.
详细描述
The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous enrolment in the PSM8 study in the period from March, 1st 2014 to March, 31st 2016 with the following:
- •Any gender and age above 18 years.
- •Cataract or Refractive Lens Exchange (RLE) surgery; will be included patients submitted to conventional phacoemulsification as to femtolaser procedure; no specification regarding corneal incision size and position.
- •Symmetrical preoperative keratometric astigmatism < 1.00 D.
- •Healthy corneas, not surgically treated
排除标准
- •Previous corneal surgery (i.e. pterygium, refractive surgery).
- •Eye diseases with visual acuity < 20/
- •Pseudoexfoliation.
- •Abnormal pupil size and position.
- •Use of contact lens 30 days before the preoperative visit.
- •Corneal warpage.
结局指标
主要结局
Subjective Refraction
时间窗: 26 months
UDVA
时间窗: 26 months
Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m
UIVA at 100 cm
时间窗: 26 months
Monocular and Binocular Uncorrected Intermediate Visual Acuity at 100 cm (100% and 10% contrast)
CDVA
时间窗: 26 months
Monocular and Binocular Corrected Distance Visual Acuity (CDVA) at 4m
DCIVA at 100 cm
时间窗: 26 months
Monocular and Binocular Distance Corrected Intermediate Visual at 100 cm (100% and 10% contrast)
DCIVA at 60 cm
时间窗: 26 months
Monocular and Binocular Distance Corrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)
Reading Performance
时间窗: 26 months
Binocular Reading Performance with and without correction for distance
UIVA at 60 cm
时间窗: 26 months
Monocular and Binocular Uncorrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)
Binocular Defocus Curve
时间窗: 26 months
Binocular Defocus Curve (+2.0 D to -4.0 D in 0.5 D increments)
UNVA
时间窗: 26 months
Monocular and Binocular Uncorrected Near Visual Acuity at 40cm (100% contrast)
Contrast Sensitivity
时间窗: 26 months
Binocular Contrast Sensitivity with correction for distance
DCNVA
时间窗: 26 months
Monocular and Binocular Distance Corrected Near Visual Acuity at 40cm (100% contrast)
VR-11R
时间窗: 26 months
Visual Function -11R Questionnaire from 4 (without difficulties) to 0 (performance impossible due to difficulties)
次要结局
- Subjective Posterior Capsule Opacification(20-26 months)
- Device Deficiencies(26 months)
- Photic Phenomena Assessment(26 months)
- Adverse Events including SSIs(26 months)
- Posterior Capsulotomy(26 months)
- Postoperative Complications Rate of postoperative complication(26 months)