Tolerance to Residual Astigmatism and Defocus in Eyes With a Non-diffractive Extended Depth of Focus (EDoF) Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Distance Against the Rule Astimatism
研究概览
简要总结
Low amounts of postoperative residual astigmatism may worsen the visual performance of patients implanted with presbyopia- correcting intraocular lenses (IOLs). Although extended depth of focus (EDoF) IOLS have introduced optical improvements, it is important to determine the tolerance of these IOLs to postoperative astigmatism. This is important for an appropriate surgical planning.
Therefore, the aim of this study is to simulate and assess the impact of mild amounts of residual mixed astigmatisms with the axis oriented in different positions (vertical, oblique and horizontal) in eyes implanted with the Vivity® IOL.
详细描述
Objectives:
- Primary objective: To describe the tolerance of simulated astigmatism on patients implanted with Vivity at far distance.
- Secondary objective: To describe the tolerance of simulated astigmatism on patients implanted with Vivity at intermediate distance.
Study Design: Prospective, single arm, descriptive, 3-month follow up.
Patient population: 30 consecutive eyes of 30 patients implanted with Vivity bilaterally with no postoperative complications. The calculation of the required sample size was based on monocular corrected distande visual acuity. A difference of 0.2 logMAR units was assumed to be clinically significant anda standard deviation of 0.05 was anticipated(data obtained from a comparative study between a bifocal and a trifocal IOL: Jonker SM, et al. Journal of Cataract Refract Surg. 2015; 41: 1631-40). Based on these assumptions, with an α of 0.05 and power of 0.8, it was calculated that 25 eyes were required in each group. Due to potential dropouts, a larger sample size has been selected.
Clinical Protocol: All patients fullfilling study criteria will be considered for inclusion three months after surgery. After patient consent, uncorrected distance visual acuity will be measured with an ETDRS chart, followed by subjective refraction (best distance correction). In all cases, mixed astigmatism will be induced with trial lens over the best distance corrected situation (considered the reference situation).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >40 years old that undergo routine cataract surgery
- •Bilateral implantation of Vivity ® IOL
排除标准
- •Corneal astigmatism ≥1.0 diopters (D )
- •Amblyopia
- •Previous ocular surgery
- •Presence of ocular pathologies
- •Abnormal iris
- •Patients with intra- or postoperative complications
- •Postoperative best distance corrected visual acuity (BDCVA) < 20/20
- •Postoperative refractive astigmatism > 0.50D
结局指标
主要结局
Distance Against the Rule Astimatism
时间窗: Three months after surgery
Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x0\*, taking as a reference the subjects' axis
Distance Oblique Astigmatism
时间窗: Three months after surgery
Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x45\*, taking as a reference the subjects' axis
Distance With the Rule Astigmatism
时间窗: Three months after surgery
Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x90\*, taking as a reference the subjects' axis
次要结局
未报告次要终点