NCT06642779已完成不适用
Comparative Analysis of the Visual Performance and Patient Satisfaction After Cataract Surgery With Implantation of a Medicontur Monofocal (877PAY) or a Medicontur Extended Depth of Focus (877PEY) IOL
Medicontur Medical Engineering Ltd3 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年12月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- DCIVA
研究概览
简要总结
The purpose of this multi-center, prospective, randomized, comparative clinical investigation was to evaluate and compare the visual performance at far, intermediate and near distances, the presence of photopic phenomena and patient satisfaction after cataract surgery in patients implanted binocularly with a Medicontur monofocal (877PAY) or a Medicontur extended depth of focus (877PEY) IOL models.
The visit schedule included a total of 6 visits, in addition to the IOL implantation surgery, with the listed follow-up timeline:
- screening and baseline assessments
- day 0 (IOL implantation surgery)
- day 1
- month 1
- month 3
- month 6
- month 12
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cataractous patients who wish to be partly spectacle independent
- •cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms*
- •best corrected visual acuity to be better than 20/25 (0.1 logMAR) after cataract removal and IOL implantation*
- •≤ 1.0 D of preoperative keratometric astigmatism;
- •clear intraocular media other than cataract;
- •given written informed consent by subject;
- •subjects are willing and able to comply with schedule for follow-up visits;
- •adult patient
排除标准
- •corneal astigmatism > 1.00 D
- •irregular astigmatism
- •diabetic retinopathy
- •iris neovascularisation
- •serious intraoperative complications
- •congenital eye abnormality
- •uncontrolled glaucoma or glaucoma with changes in optical nerve and visual field
- •pseudoexfoliation syndrome
- •amblyopia
- •long-term anti-inflammatory treatment
- •retinal detachment
- •prior ocular surgery in personal medical history
- •corneal diseases
- •severe retinal diseases (dystrophy, degeneration)
- •severe myopia (if required IOL power is lower than 10 D)
- •inadequate visualization of the fundus on preoperative examination
- •patients deemed by the clinical investigator because of any systemic disease.
- •eye trauma in medical history
- •Intraoperative exclusion criteria:
- •tear in capsulorhexis*
- •zonular dehiscence*
- •posterior capsular rupture vitreous loss and other unexpected surgical complication*
- •According to coordinator investigator's decision, the marked inclusion and exclusion criteria were not applied.
结局指标
主要结局
DCIVA
时间窗: measured at month 1, month 3, month 6 and month 12
distance corrected intermediate visual acuity
次要结局
- UDVA/CDVA(measured at month 1, month 3, month 6 and month 12)
- VADC(measured at month 3, month 6 and month 12)
- CSDC(measured at month 6 and month 12)
- Patient satisfaction(Evaluated at month 3 and month 12)
- CSV-1000(measured at month 3, month 6 and month 12)
研究者
研究点 (3)
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