Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens

Alcon Research1 个研究点分布在 1 个国家目标入组 120 人2006年10月

适应症Cataract

概览

阶段: 4 期
干预措施: 未指定
疾病 / 适应症: Cataract
发起方: Alcon Research
入组人数: 120
试验地点: 1
主要终点: Visual Acuity (VA)
状态: 已完成
最后更新: 14年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.

注册库

clinicaltrials.gov

开始日期

2006年10月

结束日期

2008年6月

最后更新

14年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Alcon Research

入排标准

入选标准

•Are a candidate for bilateral implantation
•In good general and ocular health, 21 years of age or older, of either gender or any race, diagnosed with age-related cataracts in both eyes
•In need of spherical correction between 10.0 Diopter (D) and 30.0 D
•Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by keratometry
•Willing and able to complete all required postoperative visits
•Able to comprehend and sign a statement of informed consent
•Pupil dilation ≥ 6.0 mm
•Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM evaluation);

排除标准

•Exclusion Criteria Before Surgery - Ocular
•Previous cataract patient without potential of bilateral implantation
•Females of child bearing potential
•Irregular corneal astigmatism
•Keratopathy/Keratectasia - any corneal abnormality including but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and cornea plana
•Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis
•Previous corneal reshaping, including but not limited to the following: keratomileusis, radial keratotomy (RK), photorefractive keratectomy (PRK), Laser in Situ Keratomileusis (LASIK), Thermal Keratoplasty (TK), and Penetrating Keratoplasty (PK)
•Clinically significant corneal dystrophy (including Fuch's dystrophy)
•Previous corneal transplant
•Amblyopia

结局指标

主要结局

Visual Acuity (VA)

时间窗: Pre-operative, 1 month, 3 month, and 6 month post-operative

Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).