Clinical Evaluation of the Tecnis Multifocal Intraocular Lens (IOL), Model ZM900, Original Study (DIOL-101-TCNS); Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study (DIOL-104-TCNS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 470
- 主要终点
- Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.
研究概览
简要总结
To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.
详细描述
The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Visual potential of 20/30 or better in each study eye
- •Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)
- •Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye
- •Preoperative corneal astigmatism of 1.0 D or less
排除标准
- •Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
- •Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)
- •Uncontrolled systemic or ocular disease
- •History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention
- •Presence of ocular pathology other than cataract such as:
- •Amblyopia or strabismus
- •Corneal abnormalities
- •Pupil abnormalities
- •Capsule or zonule abnormalities
- •Intraocular inflammation
- •Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)
- •Requiring an intraocular lens outside the study diopter range
- •Contact lens usage prior to study procedure (time interval dependent upon contact lens type)
研究组 & 干预措施
Tecnis Multifocal IOL group
Subjects implanted bilaterally with the Tecnis Multifocal IOL. Participants were enrolled in this arm in the original study and also in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.
干预措施: Tecnis ZM900 Multifocal Intraocular Lens (Device)
CeeOn 911A monofocal control IOL group
Subjects implanted bilaterally with the CeeOn 911A monofocal IOL. Participants enrolled in this arm only in the original study; no control subjects were enrolled in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.
干预措施: CeeOn 911A monofocal IOL (Device)
结局指标
主要结局
Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.
时间窗: One year
Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.
Mean Binocular Distance Corrected Near Visual Acuity in Snellen
时间窗: One year
Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.
次要结局
未报告次要终点