A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Observation of the applied Effective Phaco Time (EPT) for Pahcoemulsifikation during surgery. The observed Effective Phaco Time in Group A should be significantly lower than in group B. Statistically significant difference at p<0.05.
研究概览
简要总结
This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye study to determine the safety and efficacy of intraocular cuts for femtosecond laser assisted lens frag-mentation to support phacoemulsification of the cataractous lens prior to IOL implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with the CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size.
The hypothesis of the study is that by means of femtosecond laser assisted lens fragmentation the required ultrasound energy used for phacoemulsification can be reduced in a safe and effective way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •Clear corneal media
- •Patients must be at least 18 years of age.
排除标准
- •On a keratometric map of the cornea, the minimal and maximal K-values of the central 3mm zone must not differ by more than 5 dioptres. (exclusion criterium for Group A only)
- •The maximum K- value may not exceed 60 D, the minimal value may not be smaller than 37 D. (exclusion criterium for Group A only)
- •Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light. (exclusion criterium for Group A only)
- •Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally.
- •Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- •Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- •Known sensitivity to planned concomitant medications.
- •Patients with disorders of the ocular muscle, such as nystagmus or strabismus
- •Keratoconus
- •Patients with woundhealing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis
- •Abnormal examination results from slit lamp, Fundus, IOL Master
- •Abnormal examination results from Orbscan (exclusion criterium for Group A only)
- •Patients with an autoimmune disease, collagenosis or clinically significant atopy.
- •Patients who are pregnant or nursing.
- •Patients who do not give informed consent.
- •ACD < 2.4 mm or ACD > 4.5 mm as measured by ultrasonic examination (exclusion criterium for Group A only)
研究组 & 干预措施
Femtec Groupe A
In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery
干预措施: Lens Fragmentation by means of a femtosecondlaser (Procedure)
Manual Group B
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
干预措施: Manual Phacoemulsification (Procedure)
结局指标
主要结局
Observation of the applied Effective Phaco Time (EPT) for Pahcoemulsifikation during surgery. The observed Effective Phaco Time in Group A should be significantly lower than in group B. Statistically significant difference at p<0.05.
时间窗: at time of surgery
次要结局
- Less or equal adverse events in Group A compared to group B (e.g. retinal detachment, IOL malposition). p<0.05 will be considered statistically significant.(1-Day Follow-UP)
- Less or equal severe adverse events in Group A compared to group B. p<0.05 will be considered statistically significant.(1-Day Follow-UP)
- Easy of phacoemulsification as subjectively perceived by the surgeon during surgery(time fo surgery)