Combined Burst Mode Versus Torsional Mode Phacoemulsification for Patients With Hard Nuclear Cataract: A Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Endothelial cell density
研究概览
简要总结
In this study, we compared two types of phacoemulsification commonly used in cataract surgery to evaluate their effect on the prognosis of patients with hard nuclei. This will provide a theoretical basis for selecting a more appropriate cataract surgery modality in practice in hard-nucleus patients.
详细描述
In this study, we randomized patients into two groups. One group was the combined mode group in burst mode and the other group was the torsional ultrasound group in continuous mode. Cumulative dissipated energy(CDE) and ultrasound time(UST) were recorded during the procedure. Changes in central cornea thickness(CCT) and endothelial cell density(ECD) of the patients were recorded postoperatively during a 3-month follow-up. Intraoperative and postoperative complications were also recorded. The above data were analyzed to compare the effect of both on postoperative corneal recovery in patients with hard nuclei.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with age-related cataracts that were only classified by Emery-Little as nuclear hardness grade III-V.
- •encompassed a minimum dilated pupil diameter of 7 mm or above, as well as a corneal endothelial cell count exceeding 1200/mm^
- •Corneal morphology is normal and clear
- •Informed consent is required prior to enrollment
排除标准
- •Those with white cataracts, histories of eye surgery, and eye diseases such as corneal pathology, uveitis, Fuchs' dystrophy, and glaucoma were excluded.
- •Exclude those with comorbid ocular and systemic diseases that affect corneal endothelial cell function
- •Exclude those with previous intraocular surgery
研究组 & 干预措施
torsional mode
torsional mode under continues mode (Linear Tor) Phacoemulsification mode Continuous mode Torsional amplitude 0-90% Longitudinal power 0 Infusion system Gravity fed Bottle height 50-80 cm Vacuum 360 mmHg Aspiration flow rate 30 cm3/min Burst duration - Off time -
干预措施: torsional mode (Procedure)
Combined burst mode
combining the torsional and vertical ultrasound under burst mode(Burst Tor+ Burst US) Phacoemulsification mode Brust mode Torsional amplitude 0-90% Longitudinal power 40% Infusion system Gravity fed Bottle height 50-80 cm Vacuum 360 mmHg Aspiration flow rate 30 cm3/min Burst duration 70 ms Off time 50 ms
干预措施: combined burst mode (Procedure)
结局指标
主要结局
Endothelial cell density
时间窗: At 1day, 1week, 1month, 3months postoperatively.
Endothelial cell density after cataract surgery.
ultrasound time
时间窗: During cataract surgery
ultrasound time during phacoemulsification.
central cornea thickness
时间窗: At 1day, 1week, 1month, 3months postoperatively.
central cornea thickness after cataract surgery.
cumulative dissipated energy
时间窗: During cataract surgery
cumulative dissipated energy during phacoemulsification.
次要结局
- best-corrected distance visual acuity(At 1day, 1week, 1month, 3months postoperatively.)
- cornea edema(At 1day, 1week, 1month, 3months postoperatively.)
- occlusion(during surgery)