"Comparative Study of High-frequency Pulsed Vacuum Technology Versus Phacoemulsification for Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Endothelial cell count by specular microscopy after each surgery
研究概览
简要总结
Cataracts are cloudings of the lens, primarily due to aging. Surgery is the primary treatment for cataracts. The most commonly used surgical technique is phacoemulsification, which involves fragmenting the lens using a high-frequency ultrasound probe and removing the fragments. Phacoemulsification is more common due to its advantages.
Recently, a new approach has emerged, using high-frequency pulsed vacuum technology for cataract ablation. This less invasive approach is expected to allow for faster patient recovery and reduce surgical risks. High-frequency pulsed vacuum utilizes the pulse-pulse principle by interrupting the vacuum every tenth of a second. This interruption creates an impact moment between the cataract material and the cannula tip, dissecting the cataract without damaging the surrounding delicate tissue. High-frequency pulsed vacuum maintains anterior chamber stability while creating sufficient dissection to aspirate the cataract material. This energy also cools the tip, allows for better vacuum control, and significantly reduces turbulence within the eye. More importantly, high-frequency pulsed vacuum disrupts endothelial cells less and causes less edema than mechanical ultrasound.
This technique therefore appears ideal for treating patients with at-risk corneas (low endothelial cell count, risk of decompensation and corneal transplantation).
The objective of the study is to demonstrate the benefits of this approach using high-frequency pulsed vacuum technology through a randomized, comparative, crossover study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adult patient
- •Patient with bilateral cataracts
- •Grade 1 to 3 cataracts
- •Indication for bilateral cataract surgery
- •Patient informed of the study and having given their written and signed informed consent
- •Patient affiliated with a social security scheme or beneficiary of such a scheme
排除标准
- •Refusal of consent
- •Cataract grade > 3
- •Unilateral and/or combined cataract surgery
- •Uveitic cataract
- •Patient with ocular comorbidity
- •Patient with cognitive impairment preventing them from responding to satisfaction questionnaires
- •Patient unable to read, write, or understand French
- •Pregnant or breastfeeding patient as defined in Article L1121-5 of the French Public Health Code
- •Vulnerable patient as defined in Article L1121-6 of the French Public Health Code
- •Adult patient under guardianship, curatorship, or legal protection
- •Patient unable to give personal consent
研究组 & 干预措施
TECHNIC BY PHACOEMULSIFICATION
干预措施: EYE 2 SURGERY BY CATAPULSE TECHNIC (Procedure)
TECHNIC BY CATAPULSE
干预措施: EYE 1 SURGERY BY CATAPULSE TECHNIC (Procedure)
结局指标
主要结局
Endothelial cell count by specular microscopy after each surgery
时间窗: At Day30 (+/- 7 days)
The patient is placed in front of a mirror microscope, the chin resting on a chin rest, the ophthalmologist observes the endothelial layer of the cornea through the microscope, he manually counts the endothelial cells and assesses their density
次要结局
- Visual acuity(before each procedure, between day 1 and day 5 after each procedure, and day 30 (+/- 7 days) after each procedure)
- Measurement of postoperative inflammation(Between Day 1 and Day 5 after each cataract surgery)
- The rate of postoperative complications(Between Day 1 and Day 5 after each cataract surgery, at Day30 (+/- 7 days))
- The operating times of each surgery(Perioperative)
- Satisfaction with the use of high-frequency pulsed vacuum technology by healthcare teams(Between Day 1 and Day 5 after each cataract surgery with CATAPULSE)
- A Likert scale will be used to assess patient comfort during surgery(Between Day 1 and Day 5 after each cataract surgery)
- Adverse events related to both surgeries(Between Day 1 and Day 5 after each cataract surgery and at Day30 (+/- 7 days))
