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临床试验/NCT05510869
NCT05510869已完成不适用

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

Medical University of Lodz0 个研究点目标入组 90 人开始时间: 2016年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Magdalena Kucharczyk-Pośpiech

Principal Investigator

Medical University of Lodz

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