A Randomized Controlled Trial Comparing Intraocular Caliper-assisted Capsulotomy Versus Verion Navigation System-assisted Capsulotomy for Age-related Cataract With Corneal Limbus Opacity
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Distance between pupil center and capsulorhexis center
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 for age-related cataract patients with corneal limbus opacity.
详细描述
Continuous curvilinear capsulorhexis (CCC) is an important and technically challenging procedure in cataract surgery. Too large or too small capsulorhexis can increase the incidence of intraoperative and postoperative complications.
In recent years, the image projection device Verion navigation system has been reported that it can improve the repeatability and accuracy of capsulorhexis via projecting a pre-set size ring to guide capsulorhexis. However, we found that for the patients with corneal geriatric ring, pterygium or limbal lesions leading to unclear limbal boundary, the projected capsulorhexis will deviate from the center, resulting in capsulorhexis is off center in clinical practice. Our self-developed intraocular caliper, which is modified on the conventional intraocular irrigation needle, can accurately measure the size of capsulorhexis, and mark the position and boundary of capsulorhexis on the lens anterior capsule to guide capsulorhexis, thus significantly improves the accuracy and centricity of capsulorhexis.
The purpose of this study is to compare the centricity and accuracy of intraocular caliper-assisted capsulorhexis in phacoemulsification for age-related cataract patients with corneal limbus opacity with that of Verion projection 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 with pterygium, Corneal geriatric ring, and corneal limbus opacity;
- •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
Distance between pupil center and capsulorhexis center
时间窗: During the surgery
The primary outcome was the distance between pupil center and capsulorhexis center. Clear images of the edges of IOL and capsulorhexis were taken at the end of the operation, and Image J image analysis software is used to measure the distance between pupil center and capsulorhexis center with the diameter of IOL optical surface (6 mm) as the reference by two independently professional graders at the meantime.
次要结局
- Uncorrected and corrected visual acuity(One month after surgery)
- Intraocular lens tilt(One month after surgery)
- Intraocular aberrations(One month after surgery)
- Horizontal and vertical diameter of capsulorhexis(During the surgery)
- Intraocular lens decentration(One month after surgery)
- Distance between pupil center and capsulorhexis center(One month after surgery)
- Grades of capsulorhexis-IOL overlap(During the surgery)
- Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)(During the surgery)
- Ideal ratio of capsulorhexis(During the surgery)