NCT03356847已完成不适用
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年9月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Rotational stability of SISA monofocal implant following cataracts surgery
研究概览
简要总结
A good efficacy as well as good rotary stability is expected with the ocular implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient must be available for 6 months follow-up
- •The patient it aged at least 18 years
- •Patient requires surgery for cataracts with removal of the opacified natural lens and replacement with the SISA implant, according to standard procedure
- •The surgery is elective
- •The patient has clear and non-pathological corneas
- •The patient needs an implant strength (LIO) between +10D and +30D
- •Corneal astigmatism less than or equal to 1.50D in the eye to be operated (or cataract eye
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The patient is under safeguard of justice or state guardianship
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is pregnant or breastfeeding
- •The patient has other ocular comorbidities with poor visual acuity prognosis postoperatively
- •Previous ocular trauma or surgery
- •Dilation of the pupil <7mm with mydriatic drugs
- •Implantation with a rhexis that does not cover the optic of the implant by more than 1 cadranel
研究组 & 干预措施
SISA implant
Experimental
干预措施: Fitting of ocular implant (Device)
结局指标
主要结局
Rotational stability of SISA monofocal implant following cataracts surgery
时间窗: 4 Months
rotation in degrees measured by Labview software
次要结局
- Centering of SISA monofocal implant(Month 4)
- Visual acuity with and without correction(Month 4)
- Refractive precision(Month 4)
- Postoperative complications(Day 7)
- Rotational stability of SISA monofocal implant following cataracts surgery(1 Month)
- Perioperative complications(Day 0)
- Occurrence of undesirable events,(Month 7)
研究者
研究点 (2)
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