Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Spectacle independency
研究概览
简要总结
The purpose of this study is to determine if Toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal intraocular lens implantation.
详细描述
A recent innovation in cataract surgery consists of the introduction of toric intraocular lenses (IOLs) that can correct corneal astigmatism. It offers the opportunity for patients with substantial astigmatism to achieve optimal distance vision without using spectacles. Good near vision may subsequently be achieved with low-cost reading glasses. The current practice of non-toric IOL implantation in astigmatic patients warrants the use of expensive bifocal or multifocal spectacles with cylinder correction to achieve good distance and near vision.
Objective
The primary objective of this study is to compare spectacle independence for distance vision following toric IOL implantation and monofocal intraocular lens (IOL) implantation. The secondary objectives are to compare uncorrected distance vision, residual refractive astigmatism, quality of vision, wavefront aberrations, contrast sensitivity, complication profile, costs of postoperative spectacles and cost-effectiveness.
Study design: Multi-centre randomised clinical trial. Study population: 160 patients with regular corneal astigmatism of at least 1.25 diopters in both eyes who require bilateral cataract surgery.
Intervention: Cataract surgery with implantation of a toric IOL (AcrySof model SN60TT) or an monofocal IOL (AcrySof model SN60AT).
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, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral cataract
- •Bilateral corneal astigmatism (at least 1.25D)
- •Predicted residual astigmatism less than 0.5D
排除标准
- •Irregular corneal astigmatism or keratoconus
- •Fuchs endothelial dystrophy (stage 2)
- •Expected postoperative best-corrected visual acuity worse than logMAR +0.3
结局指标
主要结局
Spectacle independency
时间窗: preop, 3 months and 6 months postop
Spectacle independency for distance vision
次要结局
- Costs related to intervention(preop, 3 and 6 months postop)
- Visual acuity(preop, 1 day, 1 month, 3 months and 6 months postop)
- Higher-order wavefront aberrations(preop, 3 months and 6 months postop)
- Contrast sensitivity(preop, 3 months and 6 months postop)
- Refractive astigmatism(preop, 3 months and 6 months postop)
- Quality of vision(preop, 3 months, 6 months)