Spherical Aberration and Contrast Sensitivity in Eyes Implanted With Aspheric and Spherical Intraocular Lenses: Clinical Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery
研究概览
简要总结
Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery.
Design: Prospective, comparative, interventional case series.
Methods: In an intraindividual randomized prospective study of 25 patients with bilateral cataract, an IOL with a modified anterior surface (Tecnis Z9001, AMO- Group 1) was compared with biconvex lens with spherical surfaces (ClariFlex®, AMO- Group 2). Ocular aberrations for a 5.0 mm pupil and 6.0 mm pupil were measured with Hartmann-Shack aberrometer. Quality of vision was measured by visual acuity and contrast sensitivity under mesopic and photopic conditions. All patients were followed for 3 months.
详细描述
With improvement in the quality of life and the resulting expansion of the elderly population, the prevalence of cataract cases will continue to rise. The population is on average older, and the environment has become more demanding for older people, who therefore need to regain excellent quality of vision. Advances in both IOL and phacoemulsification technology have enable cataract surgery to evolve from a procedure concerned with the safe removal of the cataract to a procedure refined to achieve the best possible postoperative refractive result.
Snellen visual acuity insufficiently describes the quality of the eye's optics before and after cataract surgery. 1-3 Multiple scientific studies have demonstrated that contrast sensitivity represents a robust indicator of functional vision. 4-7 The contrast sensitivity function, measured under varying conditions of luminance and glare, establishes the limits of visual perception across the spectrum of spatial frequencies.
Studies have demonstrated a nearly linear decline in image quality with age, suggesting a significant increase in the optical aberrations in the eye over time. 8-9 Advances in wavefront technology have opened a new door to the measurement of ocular aberrations. 9-10 Also, this technology allowed the development of a new type of IOL designed to compensate for the positive spherical aberration of the cornea, which is one of the most important aberrations contributing to visual deterioration of the pseudophakic eye. 11-14 Based on these findings, the approach to compensate for increasing spherical aberration in older eyes is to develop an IOL that introduces negative spherical aberration into the system. Such an IOL, the Tecnis Z9001® IOL (Model Z9001, Advanced Medical Optics, Santa Ana, CA), has been developed by AMO. This is a polysiloxane foldable 3-piece IOL, with anterior aspheric surface (negative spherical aberration) designed to decrease the total amount of ocular spherical aberration after cataract surgery.7
The purpose was to determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery.
Patients and Methods
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, Investigator)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age-related cataract
- •No indication of existing ocular pathology
- •Unsatisfactory correction with glasses and
- •Less than 2.50 diopters (D) of topography cylinder.
排除标准
- •Previous ocular surgery
- •Central endothelial cell count less than 1800 cells/mm2
- •Glaucoma or intraocular pressure greater than 21 mmHg
- •Amblyopic eyes
- •Retinal abnormalities
- •Diabetes mellitus
- •Steroid or immunosuppressive treatment, and
- •Connective tissue diseases
结局指标
主要结局
To determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery
时间窗: within the first 30 days of surgery
次要结局
未报告次要终点