Visual Outcomes and Patient Satisfaction Results After Implantation of a Monofocal Intraocular Lens Designed for Monovision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
The rationale for this observational study of a CE-marked lens is to prospectively assess the performance, safety, and patient satisfaction in a group of subjects undergoing cataract surgery with bilateral implantation of the RayOne EMV in a monovision configuration. In order to increase the evidence collected from real-world clinical data we are running a multicentre clinical study in several clinics of the Baviera Ophthalmological Group.
Study design: prospective, observational, non-comparative.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Availability to complete follow-up examinations up to 6 months after surgery
- •Cataract for which removal by phacoemulsification and subsequent IOL implantation was planned
- •CDVA was expected to be better than 20/30 (+0.18 logMAR) after IOL implantation
- •IOL power calculated in the range of +10.0 to +30.0 D
- •Corneal astigmatism < 1.50 D
- •Candidate for refractive surgery in monovision configuration
排除标准
- •Women who were pregnant, nursing or planning to become pregnant during the study
- •Difficulty for cooperation
- •Inability to provide informed consent
- •Concurrent participation in another investigational drug or device
- •History of ocular trauma
- •Previous intraocular or corneal surgery
- •Presence of ocular pathologies
- •Subjects with diagnosed degenerative visual disorders that were predicted to cause future acuity losses to a level of 20/30 or worse
- •Subjects who may be expected to require retinal laser treatment
- •Other eye condition that in the opinion of the investigator prevents the subject's participation in the study.
- •Any other condition that may be contraindicated according to the IOL Instructions for Use.
结局指标
主要结局
Visual acuity
时间窗: One month postoperative
Visual acuity was measured using standard clinical charts
Defocus curve
时间窗: One month postoperative
Defocus curve was measured using standard clinical charts
Patient Satisfaction
时间窗: One month postoperative
Patient satisfaction was measured using the Cataract Assessment Patient Questionnaire 9 Short Form (Catquest 9SF) from 1 to 5, being 1 major difficulties and 5 cannot decide
次要结局
- Safety of the device(Surgery, first follow-up visit (1-month) and second follow-up visit (6-months))
- Quality of vision(One month postoperative)