Prospective Clinical Trial to Compare the Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Horizontal position stability
研究概览
简要总结
The main objective of the trial is to assess the efficacy of the CT LUCIA 611P intraocular lens (IOL) with regard to the horizontal IOL position stability. The horizontal position collected at 1 month and 4 to 6 months post-operatively will be compared to the horizontal IOL position recorded at baseline (1 week post-operatively) as well as to the position stability of the reference IOL, CT ASPHINA 409MP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
- •Patients of any gender, aged 50 to 90 years;
- •Assured follow-up examinations;
- •Healthy eyes besides clinically significant bilateral age-related cataract.
- •Distance corrected visual acuity ≤ 0.3 logMAR Normal findings in the medical history and physical examination
- •Calculated IOL power within the available dioptre range;
- •Biometry measurement/cataract density compatible with the IOLMaster evaluation.
- •Per operative inclusion criteria:
- •IOL implanted in the capsular bag;
- •The 2 IOL models (CT LUCIA 611P and CT ASPHINA 409MP) have been implanted in the 2 eyes of one patient;
- •No intraoperative complications; no damaged capsular bag, no intraocular haemorrhage; no can opener rhexis.
排除标准
- •Allergy to heparin
- •Monophthalmic patient
- •Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye;
- •Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.);
- •Floppy iris syndrome;
- •Diabetic retinopathy;
- •Traumatic cataract;
- •Aniridia;
- •Microphthalmus;
- •Amblyopia;
- •Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders);
- •Patient expected to require retinal laser treatment before the end of the last follow-up;
- •Previous intraocular and corneal surgery;
- •Expected postop. astigmatism greater than 1 D;
- •Any type of corneal disorder;
- •Dementia;
- •Pseudoexfoliation syndrome (PEX);
- •Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
- •Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient.
- •Pregnancy and/or lactation
研究组 & 干预措施
LUCIA
CT LUCIA 611P - Intraocular lens
干预措施: Intraocular lens (Device)
ASPHINA
CT ASPHINA 409MP - Intraocular lens
干预措施: Intraocular lens (Device)
结局指标
主要结局
Horizontal position stability
时间窗: 1 week to 4-6 months post-operatively
Evaluation of the horizontal position stability of the CT LUCIA 611P IOL. The horizontal position at M1 and M4-6 will be compared to the horizontal IOL position at baseline (W1) and to the position stability of the reference IOL, CT ASPHINA 409MP.
次要结局
未报告次要终点