Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos AO Intraocular Lens Implantation: Clinical Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Ocular aberrations with a 5.0 mm and 6.0 mm pupil measured with a dynamic retinoscopy aberrometer
研究概览
简要总结
Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior and posterior aspherical surface (Akreos AO, Bausch & Lomb,Inc) results in reduced ocular aberrations (spherical aberration) and in improved contrast sensitivity after cataract surgery.
Study hypothesis: the implantation of an intraocular lens (IOL) with a modified anterior and posterior aspherical surface (Akreos AO, Bausch & Lomb,Inc) results in reduced ocular aberrations (spherical aberration) and improved contrast sensitivity after cataract surgery.
Setting: Department of ophthalmology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil.
Overall Study design: This will be an intraindividual randomized double-blinded prospective study. Patients will be randomized to receive an aspheric IOL Akreos AO in one eye (25 eyes; Bausch & Lomb, Inc), and an spheric IOL Akreos Fit (25 eyes; Bausch & Lomb, Inc.) in the fellow eye. Ocular aberrations with a 5.0 mm and 6.0 mm pupil will be measured with a dynamic retinoscopy aberrometer after 1 and 3 months. Uncorrected and best-corrected visual acuity, out-focus performance and contrast sensitivity under mesopic and photopic conditions will be also measured. All patients will be followed for 3 months.
详细描述
Patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.
Patients will be examined before surgery and at 1, 7, 30, 90 days after surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0D (diopters)
排除标准
- •Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
- •Surgical complications
- •Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
- •Incomplete follow-up.
结局指标
主要结局
Ocular aberrations with a 5.0 mm and 6.0 mm pupil measured with a dynamic retinoscopy aberrometer
时间窗: At 30 and 90 days postoperatively
次要结局
- Days contrast sensitivity under photopic and mesopic conditions(at 90 days postoperatively)