NCT06225362进行中（未招募）不适用
Evaluation and Clinical Outcomes After Routine Cataract Surgery With the Quatera® 700 and the Centurion® Vision System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Lens removal time
研究概览
简要总结
Phacoemulsification is the most common treatment for cataract surgery in the developed countries and over the years it gained importance due to several factors: small incision, surgery performed under topical anesthesia - which reduce injection-related complications - short recovery time, low post operatory induced astigmatism, and low incidence of surgical complications, when compared to the conventional surgeries. The study evaluates 2 different phacoemulsification devices in patients undergoing routine cataract surgery in both eyes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is undergoing bilateral lens extraction with implantation of a posterior chamber intraocular lens.
- •Gender: Males and Females.
- •Age: 50 to 80 years old. Solomon KD, DeOliveira A, Sandoval HP 4 CONFIDENTIAL CEP 23-002 Version 1.0/27Jul2023
- •Willing and able to provide written informed consent for participation in the study
- •Willing and able to comply with scheduled visits and other study procedures.
- •Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 1 to 30 days between surgeries
- •Subjects requiring an IOL power in the range of +10.0 D to +30.0 D only.
- •Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
排除标准
- •Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- •Uncontrolled diabetes.
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Contact lens use during the active treatment portion of the trial.
- •Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- •Clinically significant corneal dystrophy.
- •Corneal irregularities potentially affecting visual acuity: keratoconus, corneal dystrophy, corneal opacities.
- •Endothelial cell count less than 1500 cells/mm2
- •History of chronic intraocular inflammation.
- •History of retinal detachment.
- •Femtosecond arcuates at time of surgery.
- •Femtosecond laser assisted cataract surgery in one eye only.
- •Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- •Previous intraocular surgery.
- •Previous radial keratoromy (RK).
- •Previous keratoplasty
- •Pupil abnormalities
- •Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e. LASIK)
- •Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- •Other ocular procedures at the time of the cataract extraction (i.e., iStent)
- •Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- •Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
结局指标
主要结局
Lens removal time
时间窗: Intraoperative
from end of rhexis to complete nucleus removal
Central corneal thickness
时间窗: Postoperative day 1
次要结局
未报告次要终点
研究者
研究点 (2)
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