Assessment of Visual and Refractive Results, and Rotational Stability of the TECNIS® Eyhance Toric II 1-piece Posterior Chamber Lens in Patients With Astigmatism Undergoing Cataract Surgery: a Prospective Cohort Study - STATE
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative
研究概览
简要总结
Cataract surgery is one of the most common procedures performed worldwide. Astigmatism is the most common refractive disorder in adults, hence there is a high prevalence of preexisting astigmatism in cataract patients. Access to astigmatism correction during cataract surgery allows for improved visual outcomes for patients. Toric intraocular lenses (IOLs) are the procedure of choice to correct corneal astigmatism of one diopter or more in cases undergoing cataract surgery. Rotational stability is a key factor for successful outcomes with toric IOLs. Postoperative toric IOL misalignment is the major factor responsible for suboptimal visual outcomes after toric IOL implantation.
The TECNIS® Eyhance Toric II 1-piece posterior chamber lens is a new toric IOL which is FDA approved and CE marked. Marketed by Johnson & Johnson Vision, it is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder.
No study assessing the early rotational stability of the TECNIS® Eyhance Toric II IOL has been published yet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years
- •Patients scheduled for bilateral cataract surgery
- •For at least one eye :
- •Cataract surgery clinically indicated
- •Corneal astigmatism ≥ 1 D
- •Planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens
- •Non inclusion criteria
- •Pregnant or breast-feeding women
- •In the eye with planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens:
- •Irregular astigmatism (keratoconus suspicion)
- •Corneal scaring in visual axis
- •Retinal impairment that may limit visual recovery (macular degeneration, history of retinal detachment, etc.)
- •Visually impaired eye since childhood that cannot be improved despite correction of the refractive disorder
- •Any other ophthalmic disease inducing visual impairment
排除标准
- 未提供
研究组 & 干预措施
Patients operated with a TECNIS® Eyhance Toric II 1-piece posterior chamber lens
For at least one eye : Planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens
干预措施: Images of the operated eye (s) (Procedure)
结局指标
主要结局
The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative
时间窗: 1 month
The mean of the best monocular corrected distance visual acuity (CDVA) (logMAR) preoperative (maximum 12 months before surgery)
时间窗: 12 months
次要结局
未报告次要终点