Comparison of Surgically Induced Astigmatism After Microincision Cataract Surgery (B-MICS 1.4 mm and C-MICS 1.8 mm) and C- SICS 2.4 mm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- autorefractometry
研究概览
简要总结
The aim of the study is to compare functional results and complications of 3 methods of cataract phacoemulsification: bimanual 1.4 mm cataract surgery (B-MICS), coaxial 1.8 mm cataract surgery (C-MICS) and coaxial 2.4 mm small incision cataract surgery.
详细描述
Reduction of the width of the corneal incision was one the main changes taking place in cataract surgery in recent years. The common use of foldable intraocular lenses (IOLs) and technological development of phaco machines allowed to reduce clear corneal incision below 3 mm. Term of Microincision Cataract Surgery (MICS) understood as cataract phacoemulsification performed with the incision width below 2 mm was defined by professor Alio in 2003. However, despite various modifications introduced in recent years, phacoemulsification still causes damage of the tissues that results in surgically induced astigmatism.
Two MICS techniques have been developed: bimanual microincision cataract surgery (B-MICS) and coaxial microincision cataract surgery (C-MICS).
In the bimanual technique cataract phacoemulsification can be performed through the main incision 1.4 mm wide due to the usage of sleeveless phaco tip (without irrigation) and irrigation chopper. The advantage of separation the irrigation from aspiration is improvement of liquid dynamics in the anterior chamber. Moreover, due to the usage of the irrigation chopper, in B-MICS it is possible to lower the mean ultrasound energy.
In coaxial technique MICS phacoemulsification is performed through the incision 1.8 mm wide with usage of phaco tip with a silicon irrigation sleeve.
The aim of the study is to compare functional results and complications of 3 methods of cataract phacoemulsification: bimanual 1.4 mm cataract surgery (B-MICS), coaxial 1.8 mm cataract surgery (C-MICS) and coaxial 2.4 mm small incision cataract surgery. Moreover, this study aimed to evaluate the impact of corneal width on best corrected visual acuity (uncorrected and corrected), surgically induced astigmatism, endothelial cell loss, intraocular pressure, anterior segment of the eye and central retinal thickness.
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
- 35 Years 至 87 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lens opacities which were an indication for cataract surgery and absence of exclusion criteria,
- •cataract sclerosis grade from II to IV in Lens Opacities Classification System LOCS III scale (The Lens Opacities Classification System III).
排除标准
- •history of ocular surgery, ocular trauma,
- •congenital ocular malformations, amblyopia,
- •corneal disorders (including corneal opacities and scars),
- •best corrected visual acuity (BCVA) ≥ 0.9,
- •preoperative endothelial cell density <1500 cells/mm2,
- •history of uveitis, diabetic retinopathy,
- •retinal and macular disorders,
- •eventful phacoemulsification
- •presence of other diseases that could affect the postoperative visual outcomes.
结局指标
主要结局
autorefractometry
时间窗: 36 months
measured in diopters (D)
central corneal thickness (CCT)
时间窗: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
peripheral nasal corneal thickness
时间窗: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
the best uncorrected visual acuity
时间窗: 36 months
examined with digital Snellen chart, measured in decimal scale
endothelial cell density (ECD)
时间窗: 36 months
measured in endothelial cells/mm2
keratometry
时间窗: 36 months
measured in diopters (D)
intraocular pressure (IOP)
时间窗: 36 months
measured in millimeters of mercury (mmHg)
peripheral temporal corneal thickness
时间窗: 36 months
measured at the main incision site with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
parafoveal retinal thickness
时间窗: 36 months
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
the best corrected visual acuity
时间窗: 36 months
examined with digital Snellen chart, measured in decimal scale
anterior chamber depth (ACD)
时间窗: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
length of the clear corneal incision
时间窗: 36 months
the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
the white-to-white (WTW) distance - the horizontal corneal diameter
时间窗: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).
anterior chamber angle
时间窗: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
central foveal thickness (CFT)
时间窗: 36 months
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
次要结局
- surgically induced astigmatism SIA(36 months)
研究者
Magdalena Kucharczyk-Pośpiech
Principal Investigator
Medical University of Lodz
