Evaluation of the Acrysof Toric SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.00 D.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- The primary benefit from implantation of an IOL and participation in this study is the restoration of useful vision following removal of the cataracts.
研究概览
简要总结
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after implantation of a toric IOL in patients with predicted residual corneal astigmatism between 0.75 and 1.00 D.
Cataract is prevalent throughout the world and IOLs are routinely implanted after the extraction of the cataractous lens. It is the most frequently performed surgery in the United States with an estimated 2-3 million procedures performed annually. With the aging population on the rise, as well as the increasing popularity of refractive intraocular lenses, the number of intraocular surgeries continues to rise. Over the years, the surgical technique has evolved from intracapsular extraction to modern phacoemulsification. This development has helped with the evolution of IOLs as well. The IOLs have advanced extensively: different materials and designs are available, permitting implantation through smaller, sutureless incisions. Traditional IOLs are of monofocal design providing vision at one distance, typically far; and correct mainly the spherical component of the refractive error. However, there are patients with corneal astigmatism that require additional surgical treatment such as laser correction (laser in situ leratomileusis, LASIK; photorefractive keratectomy, PRK) or limbal relaxing incisions, RLI). Another alternative is the use of a toric IOL, which has been especially designed to correct both the sphere and the astigmatism. The ACRYSOF Toric IOL is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and preexisting comeal astigmatism in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.
The treatment selection of the corneal astigmatism depends on the amount of cylinder as follows, between 0.25 and 0.75 D creating the surgical incision on the steep axis; between 0.75 and 1.75 D, RLI; between 1 and 2.25 D, toric IOLs; and between 1 and 3.00 D, LASIK/PRK.
详细描述
This is a prospective, non-randomized, unmasked pilot study.
- SETTING: Storm Eye Institute, Medical University of South Carolina, Charleston, SC and one additional site in USA.
- SUBJECTS A total of 40 eyes (20 per site) of 20 subjects of both sexes and any race undergoing routine phacoemulsification and intraocular lens implantation will be included.
2.1. Patient Inclusion Criteria: Subjects MUST fulfill the following conditions to qualify for enrollment into the trial 2.1.1. Subject must have an age-related cataract in both eyes.
2.1.2. 21 years of age or older. 2.1.3. Patient must desire cataract extraction. 2.1.4. Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries. 2.1.5. Cross-cylinder value calculation from the Toric Calculator indicates a cross-cylinder correction from 0.75D to 1.0D in at least one eye and up to 1.75 in the fellow eye.
2.1.6. Willing and able to comply with scheduled visits and other study procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
- •Subject must have an age-related cataract in both eyes.
- •21 years of age or older.
- •Patient must desire cataract extraction.
- •Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
- •Cross-cylinder value calculation from the Toric Calculator indicates a cross-cylinder correction from 0.75D to 1.0D in at least one eye and up to 1.75 in the fellow eye.
- •Willing and able to comply with scheduled visits and other study procedures.
排除标准
- •Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- •Preoperative ocular pathology:
- •Amblyopia
- •Rubella cataract
- •Proliferative diabetic retinopathy
- •Shallow anterior chamber
- •Macular edema
- •Retinal detachment
- •Aniridia or iris atrophy
- •History of iritis
- •Iris neovascularization
- •Medically uncontrolled glaucoma
- •Microphthalmus or macrophthalmus
- •Optic nerve atrophy
- •Macular degeneration (with anticipated best postoperative visual acuity less than 20/30)
- •Advanced glaucomatous damage, etc.
- •Planned postoperative refraction for mono-vision.
- •Uncontrolled diabetes.
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Contact lens use during the active treatment portion of the trial.
- •Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- •Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
- •Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
- •Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- •Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
- •Other ocular surgery at the time of the cataract extraction.
研究组 & 干预措施
The Acrysof toric SN60T3 IOL
Multifocal Intraocular Lens
干预措施: The Acrysof toric SN60T3 IOL (Device)
结局指标
主要结局
The primary benefit from implantation of an IOL and participation in this study is the restoration of useful vision following removal of the cataracts.
时间窗: 6 months
次要结局
未报告次要终点