NCT00425464终止3 期
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 410
- 试验地点
- 20
- 主要终点
- Distance corrected near visual acuity
研究概览
简要总结
The purpose of the study is to determine if the Synchrony Dual Optic Accommodating Intraocular Lens can be used safely and effectively in post cataract extraction subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be scheduled to undergo primary intraocular lens implantation for the correction of aphakia following extraction of a senile cataract.
- •Patients must have a cataract causing reduction in visual acuity to a level of 20/40 or worse with BAT on medium setting.
- •Patients must require Synchrony® Lens correction of 16D - 28D or, if participating in the control study, patients must require a Clariflex® (AMO®), Phacoflex® II models SI30NB (AMO®) or a SI40NB (AMO®).
- •Patients must have ≤ 1.0 D of preoperative keratometric astigmatism.
- •Patients must have clear intraocular media other than cataract(s).
- •Patients must be age 50 or older at the time of implantation.
- •Patient must be willing and able to return for all scheduled follow-up examinations and have signed a written informed consent form.
排除标准
- •Patients with any anterior segment pathology (anterior segment or corneal abnormalities, chronic uveitis, iritis, corneal dystrophy, pseudoexfoliation, etc.).
- •Patients with glaucoma, glaucoma suspect or ocular hypertension, i.e., IOP > 22 mmHg.
- •Patients with previous retinal detachment or retinal pathology including age- related macular degeneration.
- •Patients with diabetes, currently being treated systemically.
- •Patients with systemic or ocular disease that may prevent the patient from achieving uncorrected distance visual acuity of 20/32 or better post operatively.
- •Patients with congenital bilateral cataract.
- •Patients who require chronic administration of any topical ophthalmic or systemic medication that may affect accommodation such as mydriatic, cycloplegic and myotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, anticholinergic agents. The use of tamsulosin hydrochloride (Flomax®) is also excluded preoperatively due to floppy iris syndrome.
- •Patients with best corrected visual acuity of 20/80 or worse in the fellow eye not attributable to cataract.
- •Patients who are currently participating or have participated in an investigational study, other than this study, within the past 60 days.
- •Patients who have had previous ocular surgery in the operative eye, including refractive surgery.
研究组 & 干预措施
Synchrony® Dual Optic Intraocular Lens
Experimental
干预措施: Synchrony® Dual Optic Intraocular Lens (Device)
Standard Monofocal Intraocular Lens
Active Comparator
干预措施: Standard Monofocal Intraocular Lens (Device)
结局指标
主要结局
Distance corrected near visual acuity
时间窗: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
次要结局
- Best corrected distance visual acuity(1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo)
研究者
研究点 (20)
Loading locations...
相似试验
已完成
不适用
Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter StudyCorneal DiseaseHypersensitivityNCT00804505SynergEyes, Inc.98
已完成
不适用
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)AphakiaNCT04098367Alcon Research222
已完成
不适用
An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia ProgressionMyopiaNCT01729208Coopervision, Inc.144
已完成
不适用
Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TMCataract SenileLenses, IntraocularNCT03512626Parc de Salut Mar32
已完成
不适用
Clinical Performance of a Phakic Intraocular Lens (IOL)PresbyopiaNCT03499821Staar Surgical Company41