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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2012年9月

概览

阶段
不适用
干预措施
Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation
疾病 / 适应症
Cataract
发起方
Sun Yat-sen University
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)
状态
已完成
最后更新
10年前

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.

注册库
clinicaltrials.gov
开始日期
2012年9月
结束日期
2012年12月
最后更新
10年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Sun Yat-sen University
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

入排标准

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

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

Single-piece IOL Group

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

干预措施: Subconjunctival dexamethasone

Single-piece IOL Group

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

干预措施: Viscoelastic materials

Single-piece IOL Group

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

干预措施: proparacaine

Three-piece IOL Group

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

Three-piece IOL Group

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

干预措施: Subconjunctival dexamethasone

Three-piece IOL Group

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

干预措施: Viscoelastic materials

Three-piece IOL Group

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

干预措施: proparacaine

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)

研究点 (1)

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