Comparing the Effect of Depth of Focus Difference in High Myopic Patients Receiving Cataract Operations Between 3D Visualization System and Traditional Optical Microscope.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of times of Microscopic focus adjustment, measured by counting from the video recordings
研究概览
简要总结
This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes.
详细描述
The objective of this study is to compare the surgical outcomes and parameters between cataract surgeries performed using the NGENUITY® 3D Visualization System (Alcon, TX, USA), a 3D imaging system, and the current standard binocular microscope in highly myopic patients. The focus is on evaluating the differences in depth of field and their impact on intraoperative parameters and outcomes.
This prospective randomized controlled trial aims to enroll patients with both high myopia and cataracts requiring surgical intervention. Participants will be randomly assigned to undergo cataract surgery using the current standard binocular microscope (control group) or the NGENUITY® 3D Visualization System (Alcon, TX, USA) (study group). The study will compare intraoperative parameters, surgical outcomes, and the incidence of potential complications, including the frequency of microscope adjustments during surgery, total distance of adjustments during surgery, distance needed to achieve clear focus from the corneal surface to the posterior capsule, surgical duration, cumulative ultrasound energy during surgery, and occurrence of surgical complications.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High myopia (axial length of 26 millimeters or more).
- •Presence of clinically significant age-related nuclear cataract requiring surgery, assessed using the International Classification System for Cataract (Lens Opacities Classification System III, LOC III), with a graded score indicating nuclear cataract (LOC III NC/NO grade 3-5).
- •Participants must be 20 years of age or older.
排除标准
- •The target eye has undergone vitrectomy surgery.
- •The target eye has undergone corneal refractive surgery.
- •Presence of corneal diseases such as corneal dystrophy, corneal trauma, corneal scarring, corneal ulcers, or clinically significant corneal softening that significantly affects the clarity of cataract surgery.
- •Complicated cataracts with features such as extreme hardness, complex composition, zonular laxity, lens dislocation, extensive capsular fibrosis, or those falling under the international cataract classification standards LOCIII NO/NC6 or C4-C5 or P4-P
- •Presence of other non-myopia-related eye diseases significantly affecting the complexity of surgery, such as adhesive uveitis causing adhesions, corneal damage due to trauma or lens dislocation, structural changes and adhesions due to intraocular inflammation, or severe uncorrected strabismus affecting eye alignment.
研究组 & 干预措施
Conventional-binocular-microscope-assisted standard cataract operation
In this group, patients undergo standard modern cataract operation during which the surgeon use conventional binocular microscope
干预措施: Standard cataract operation (Procedure)
Alcon-NGENUITY® (NG)-System-assisted standard cataract operation
In this group, patients undergo standard modern cataract operation during which the surgeon use the Alcon NGENUITY® (NG) System
干预措施: Standard cataract operation (Procedure)
Alcon-NGENUITY® (NG)-System-assisted standard cataract operation
In this group, patients undergo standard modern cataract operation during which the surgeon use the Alcon NGENUITY® (NG) System
干预措施: Alcon-NGENUITY®(NG)-system (Device)
结局指标
主要结局
Number of times of Microscopic focus adjustment, measured by counting from the video recordings
时间窗: Throughout operation
A video recorder will focus on the sliding joint between main suspension arm of microscope and its lens system. Once the surgeon change the focus, the marks on both side of the joint will change their relative positions. The times of changes will be counted from the video recording.
次要结局
- Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope(During the operation, immediately after lens material is removed, and immediately before the intraocular lens is implanted.)
- Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope(Throughout operation)
- Total operation time(Throughout operation)
- Number of Participants with post-operative complication(Within three month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3)
- Best-corrected visual acuity of the operated eye of Participants at each postoperative follow-up within 3 month, measured with Snellen chart under standard condition (6 meters in distance and standard illumination of environment)(Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3)
- Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion)(Throughout operation)
- Number of Participants with intraoperative complication(Throughout operation)
- Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer(Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3)