Comparison of Intraocular Caliper-assisted and Verion Navigation System-assisted Capsulotomy in Phacoemulsification Surgery: A Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)
研究概览
简要总结
The purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality of patients.
详细描述
Continuous curvilinear capsulorhexis (CCC) is an important and technically challenging procedure in cataract surgery. However, most surgeons perform CCC by experience or referring to the pupil size, which is highly subjective and the accuracy of capsulorhexis is unsatisfactory. The investigators developed a new modified intraocular caliper with standard calibration on the rinse needle, which can measure and locate the position of capsulorhexis. The surgeon can gently use the blunt needle in the front of the intraocular caliper to further make corresponding markers on the lens anterior capsule, and then carry out capsulotomy according to the marks. We found intraocular caliper-assisted capsulotomy can obviously improve the accuracy of capsulorhexis. The purpose of this study is to compare the accuracy and postoperative visual quality of intraocular caliper-assisted capsulotomy with those of digital image projection device VERION navigation system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 55 to 80 years with age-related cataract;
- •Pupil diameter ≥ 6.5mm after pupil dilation;
- •Lens nuclear opacity grading score (LOCS III) lower than 4.0.
排除标准
- •Patients had previous intraocular surgery;
- •Patients with a diagnosed eye disease that may affect the functions of lens suspensory ligament such as previous ocular trauma, lens subluxation, pseudoexfoliation syndrome, retinal pigment degeneration;
- •Patients had other ocular diseases that impair visual function include optic neuropathy, uveitis, and tumor.
- •Refused to participate the study.
结局指标
主要结局
Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)
时间窗: During the surgery
Images of the edges of IOL and capsulorhexis are taken at the end of the operation. Image J image analysis software is used to measure the horizontal diameter and vertical diameter of capsulorhexis with the diameter of IOL optical surface (6 mm) as the reference by two independently professional graders at the meantime, and further calculate the deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm) .
次要结局
- Intraocular aberrations(One month after surgery)
- Grades of capsulorhexis-IOL overlap(During the surgery)
- Intraocular lens tilt(One month after surgery)
- Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)(One month after surgery)
- Intraocular lens decentration(One month after surgery)
- Uncorrected and corrected visual acuity(One month after surgery)
- Distance between pupil center and capsulorhexis center(During the surgery)
- Ideal ratio of capsulorhexis(During the surgery)
- Horizontal and vertical diameter of capsulorhexis(During the surgery)