Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 30
- 主要终点
- MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
研究概览
简要总结
This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL.
The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 22 years of age
- •Bilateral cataracts for which posterior chamber IOL implantation has been planned
- •Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
- •Potential for postoperative best corrected visual acuity of 20/30 Snellen or better
- •Corneal astigmatism parameters:
- •Normal corneal topography and no irregular corneal astigmatism
- •Postoperative astigmatism can be surgically managed to be less than 1 D in each eye
- •Clear intraocular media other than cataract in each eye
- •Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
- •Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
- •Ability to understand and respond to a questionnaire in English
排除标准
- •Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study.
- •Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- •Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
- •Desire for monovision correction
结局指标
主要结局
MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
时间窗: 6 months
the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups
次要结局
- MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)(6 months)