Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 44
- 主要终点
- Rate of Severe Visual Distortions
研究概览
简要总结
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference
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
- 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
- •Preoperative keratometric cylinder in both eyes
- •Most appropriate toric IOL model choice (ZCT300 or ZCT400)
- •Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:
- •≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL
- •Clear intraocular media other than cataract in each eye
- •Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
- •Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
- •Signed informed consent and HIPAA authorization
排除标准
- •Irregular corneal astigmatism
- •Any corneal pathology/abnormality other than regular corneal astigmatism
- •Previous corneal surgery
- •Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
- •Any pupil abnormalities
- •Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
- •Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
- •Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
- •Planned monovision correction
- •Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
研究组 & 干预措施
non-toric intraocular lens
non-toric approved intraocular lens
干预措施: non-toric intraocular lens (Device)
toric intraocular lens
approved toric intraocular lens
干预措施: toric intraocular lens (Device)
结局指标
主要结局
Rate of Severe Visual Distortions
时间窗: 6 months
The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.
次要结局
未报告次要终点