Revised Capsular Polishing and Its Impact on the Positioning of the Intraocular Lens and Visual Quality Following Femtosecond Laser-assisted Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- modulation transfer function cutoff frequency (MTF cutoff)
研究概览
简要总结
This study aims to investigate the impact of improved capsular polishing on the long-term stability of effective lens position (ELP) and visual quality in patients following femtosecond laser-assisted cataract surgery combined with intraocular lens implantation. Throughout the follow-up period, changes in ELP were observed using OCT to measure the central corneal posterior surface to the IOL anterior surface. The contraction of the anterior capsule orifice was assessed through anterior segment photography, and its diameter and area were measured and analyzed using drawing software at each follow-up visit. Additionally, the investigators analyzed the correlation between the degree of anterior capsule orifice contraction and ELP, as well as examined whether ACO formed and its degree, PCO formation and its degree. Objective examination using OQAS II was conducted to measure PSF, MTF, OSI, and SR of patients; high-order aberrations including astigmatism, trifolium, and spherical aberration were measured by OPD-Scan III. Furthermore, the investigators investigated the correlation between ACO/PCO degrees and visual quality.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with age-related cataract
- •Patients seeking to reduce their reliance on corrective eyewear postoperative and exhibiting high expectations for optimal visual acuity at all distances - near, intermediate, and distant
- •Anticipated postoperative astigmatism of ≤1.00D
- •Pupil diameter in a darkened environment ranging from 3.0-5.5 mm
- •Kappa angle ≤0.5 mm or less than half the diameter of the central refractive optical zone of the MIOL.
排除标准
- •Progressive and aggravated retinal diseases, such as diabetic retinopathy, macular degeneration, preretinal membrane, vitreous macular traction syndrome, Stargardt disease, retinitis pigmentosa, etc., and serious optic nerve diseases
- •Small eyeballs, ultra-high myopia, obvious pupil abnormalities, severe corneal lesions, severe irregular astigmatism, chronic uveitis, glaucoma, obvious abnormalities of lens capsule membrane and suspension ligament, major degree alternating strabismus and other ocular organic diseases and amblyopia
- •Severe mental and psychological diseases
- •History of internal eye surgery
- •Posterior capsule rupture or uneventful in-the-bag IOL implantation
结局指标
主要结局
modulation transfer function cutoff frequency (MTF cutoff)
时间窗: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
MTF cutoff that characterizes the spatial frequency corresponding to the minimum resolution of human eyes in the modulation transfer function curve, and the higher the value is, the better the optical quality becomes,and it is immune to subjective factors and provides an objective assessment of the optical imaging quality across the entire refractive system of the artificial lens eye.
visual acuity
时间窗: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
Utilize decimal visual acuity charts for assessment purposes and record the findings in LogMAR format to facilitate statistical analysis.
strehl ratio(SR)
时间窗: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
This is one of the visual quality indicators. It's assessed by OQAS II instrument. SR that represents the ratio of the central peak value of the point spread function in an aberration-free system to that in a aberration system with the same pupil diameter, the higher the value is, the better the optical quality is.
objective scatter index (OSI)
时间窗: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
OSI that objectively reflects the scatter of the refractive medium,a higher OSI ratio indicates a more severe degree of scatter in the patient.
次要结局
未报告次要终点
研究者
Xin Zhou
Associate Senior Doctor
Xi'an People's Hospital (Xi'an Fourth Hospital)