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临床试验/NCT02609997
NCT02609997已完成不适用

Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens Via Scheimpflug Imaging System

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
The grade of in-the-bag stability between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)

研究概览

简要总结

Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have enabled the transition of cataract surgery from blindness relief to refractive correction. An ideal IOL is the critical component to achieve the refractive target of cataract surgery. Biocompatibility, rate of posterior capsule opacification (PCO) and visual quality have all been suggested as the critical factors of an ideal IOL and widely investigated. Recently, stability of IOL position has also been suggested as one of those critical factors due to its close correlation with postoperative visual function. Data suggests that IOL forward movement of 0.29 mm along the visual axis is associated with -0.4D myopic shift. Wang and colleagues recently reported that 0.5mm decentration of an aspheric IOL could eliminate its aberration-correcting effect. Poor stability could even lead to IOL exchange, an additional surgery that put both surgeons and patients in pain.

As the supporting element of an IOL, the haptics are crucial to keep the IOL in place. Various haptic designs are being compared in terms of position stability of IOLs. Haptic designs of single-piece versus 3-piece are often compared because they are currently the most commonly used types. Single-piece IOLs have soft and broader haptics which are made of the same material as the optic, usually hydrophobic or hydrophilic acrylic, whereas 3-piece IOLs have rigid haptics which are made of poly methyl methacrylate (PMMA). Clinical studies comparing these haptic designs have yielded controversial results regarding their position stability in the capsular bag, which is the most recommended site for IOL fixation in an uneventful cataract surgery.

详细描述

Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have enabled the transition of cataract surgery from blindness relief to refractive correction. An ideal IOL is the critical component to achieve the refractive target of cataract surgery. Biocompatibility, rate of posterior capsule opacification (PCO) and visual quality have all been suggested as the critical factors of an ideal IOL and widely investigated. Recently, stability of IOL position has also been suggested as one of those critical factors due to its close correlation with postoperative visual function. Data suggests that IOL forward movement of 0.29 mm along the visual axis is associated with -0.4D myopic shift. Wang and colleagues recently reported that 0.5mm decentration of an aspheric IOL could eliminate its aberration-correcting effect. Poor stability could even lead to IOL exchange, an additional surgery that put both surgeons and patients in pain.

As the supporting element of an IOL, the haptics are crucial to keep the IOL in place. Various haptic designs are being compared in terms of position stability of IOLs. Haptic designs of single-piece versus 3-piece are often compared because they are currently the most commonly used types. Single-piece IOLs have soft and broader haptics which are made of the same material as the optic, usually hydrophobic or hydrophilic acrylic, whereas 3-piece IOLs have rigid haptics which are made of poly methyl methacrylate (PMMA). Clinical studies comparing these haptic designs have yielded controversial results regarding their position stability in the capsular bag, which is the most recommended site for IOL fixation in an uneventful cataract surgery.

Most previous studies measure the IOL position based on Purkinje reflections. The measurement is time-consuming and patients are reluctant to cooperate during image acquisition. Purkinje measurement does not detect anterior chamber depth (ACD) and as such cannot reveal the IOL position along the axis. Clinical Scheimpflug systems based on rotating Scheimpflug imaging, on the other hand, is able to acquire sufficient 3-dimensioinal data points within a reasonably short period, usually seconds. It was shown that these systems are one of the best methods to estimate IOL position. To better compare the intracapsular stability between single-piece and 3-piece IOLs, the investigators measured IOL positions with rotating Scheimpflug imaging systems and tested the visual quality of patients implanted with these IOLs.

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
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of bilateral age-related cataract and age between 60 to 85 years

排除标准

  • vision-impairing diseases other than cataract, severe refractive error (Preoperative spherical equivalent of either eye >-6.00D or +5.00D)
  • history of ocular trauma, past refractive surgery or other ophthalmic surgery, capsular or zonular disorders that might affect the post-operative centration of IOLs
  • surgical complications including severe hyphema, iris injury, repeated IOL implantation
  • unable to achieve in-the-bag implantation of IOL, corneal sutures during surgery

研究组 & 干预措施

Single-piece IOL Group

Experimental

Age-related cataract patients receive in-the-bag implantation of a single-piece IOL

干预措施: Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation (Procedure)

Single-piece IOL Group

Experimental

Age-related cataract patients receive in-the-bag implantation of a single-piece IOL

干预措施: Subconjunctival dexamethasone (Drug)

Single-piece IOL Group

Experimental

Age-related cataract patients receive in-the-bag implantation of a single-piece IOL

干预措施: Viscoelastic materials (Device)

Single-piece IOL Group

Experimental

Age-related cataract patients receive in-the-bag implantation of a single-piece IOL

干预措施: proparacaine (Drug)

Three-piece IOL Group

Experimental

Age-related cataract patients receive in-the-bag implantation of a three-piece IOL

干预措施: Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation (Procedure)

Three-piece IOL Group

Experimental

Age-related cataract patients receive in-the-bag implantation of a three-piece IOL

干预措施: Subconjunctival dexamethasone (Drug)

Three-piece IOL Group

Experimental

Age-related cataract patients receive in-the-bag implantation of a three-piece IOL

干预措施: Viscoelastic materials (Device)

Three-piece IOL Group

Experimental

Age-related cataract patients receive in-the-bag implantation of a three-piece IOL

干预措施: proparacaine (Drug)

结局指标

主要结局

The grade of in-the-bag stability between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)

时间窗: 3 months after the surgery

次要结局

  • The visual acuity between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)(3 months after the surgery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haotian Lin

Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Sun Yat-sen University

研究点 (1)

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