Randomized, Controlled Trial in Patients With Senile Cataract to Evaluate the Efficacy of Ultrasound-free Femtosecond Laser (FLACS) Cataract Surgery (USFREE), Compared to Traditional Phacoemulsification Surgery Using Ultrasound.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 主要终点
- Difference in BSS volume observed between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.
研究概览
简要总结
Despite the advantages already demonstrated by FLACS, these surgeries still require ultrasonic devices for fragmentation of the lens. The ultrasonic energy used during phacoemulsification may induce complications such as reduction of endothelial cells and corneal edema. In this sense, it would be beneficial to develop surgical techniques that eliminate the need for ultrasound. The group of surgeons of Alfredo Tranjan Ophthalmic Center, recently developed a surgical technique of cataract that optimizes the use of the laser, eliminating the need for ultrasound during the surgical procedure. Thus, the crystalline fragmentation process does not involve ultrasound being performed by the laser itself. It is expected that this procedure will reduce the complexity of cataract surgery, and be safer in terms of potential corneal lesions. The present study intends to evaluate the benefit and safety of FLACS without use of ultrasound (USFREE), compared to traditional phacoemulsification surgery using ultrasound in patients with senile cataract. In this sense, it is intended to primarily compare the volume of balanced saline solution (BSS) between surgeries.
详细描述
Study hypothesis:
In cataract surgery, the FLACS USFREE technique is not inferior to the traditional phacoemulsification technique using ultrasound.
Primary Objective:
To compare non-use ultrasound FLACS (USFREE) versus traditional phacoemulsification surgery using ultrasound in eyes undergoing cataract surgery relative to the volume of BSS measured during surgery.
Secondary objective (s):
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of senile cataract, characterized as grade II nuclear (opacity according to Lens opacities classification system II [LOCS II]), in at least 1 of the eyes.
- •Obtaining the informed consent form signed by the research participant and / or legal representative.
排除标准
- •Cataract of degree other than II (LOCS II).
- •Diabetes mellitus.
- •History or presence of other ocular pathology.
- •History of laser treatment (retinal or iriane).
- •History of previous intraocular surgery.
- •Endothelial cell count <1500 cells / mm
- •Corneal thickness> 700 μm.
- •Dilated pupil with a diameter of <7.0 mm.
- •Depth of the anterior chamber <2.5 mm.
- •Contraindications for cataract surgery, including: Active proliferative diabetic retinopathy; Rubeosis iridis and / or neovascular glaucoma; Microphthalmia Buftalmia; The anterior uveitis; The cornea gutatta; Glaucoma; Retinal detachment; Other systemic or concomitant diseases that, in the opinion of the investigator, prevent the surgery from being performed or can significantly bias the results.
结局指标
主要结局
Difference in BSS volume observed between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.
时间窗: time of surgery
Difference in BSS (balanced saline solution) volume observed between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery. The volume of BSS will be measured during surgery in mL, the sum of the BSS volume observed will be compared between the 2 groups. This volume will be monitored and measured by the Centurion® phacoemulsification device.
次要结局
- Difference in time (in seconds) of phacoemulsification during surgery, between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.(time of surgery)
- Difference in visual acuity with best correction 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.(Within 30 days after surgery)
- Difference in CDE between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.(time of surgery)
- Difference in endothelial cell counts 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound.(Within 30 days after surgery)
- Difference in corneal topography 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.(Within 30 days after surgery)
- Difference in visual acuity presented 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.(Within 30 days after surgery)
- Difference in intraocular pressure 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.(Within 30 days after surgery)
- Incidence of adverse events during the study period among study participants submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound.(Within 30 days after surgery)
- Difference in corneal pachymetry 1, 7 and 30 days after cataract surgery, between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.(Within 30 days after surgery)