Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Residual Refractive Astigmatism
研究概览
简要总结
This study is designed to compare the effectiveness of LenSx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism.
详细描述
This study is a comparative, prospective, randomized contralateral eye study of visual outcomes after LenSx laser arcuate relaxing incisions utilizing the Woodcock nomogram at 90% thickness vs. manual (blade) fixed keratome diamond knife at 600 microns for arcuate relaxing incisions utilizing the Donnenfeld nomogram. Subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction and corneal astigmatism measurement with the Lenstar and slit lamp exam.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible for the study if they meet the following criteria:
- •Note: Ocular criteria must be met in both eyes.
- •are willing and able to understand and sign an informed consent;
- •are willing and able to attend all study visits;
- •are more than 40 years of age, of either gender and any race;
- •are presenting for cataract surgery or refractive lens exchange with a desire to reduce astigmatism and will be implanted with a non-toric lens
- •have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
- •have 0.50 D to 1.75 D of regular corneal astigmatism
- •have potential acuity of 20/25 or better
- •Are scheduled to have a non-toric monofocal intraocular lens (IOL) (SN60WF) lens implanted in both eyes
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Irregular astigmatism (e.g. keratoconus)
- •Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
- •Monocular status (e.g. amblyopia)
- •Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
- •Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- •Diabetic retinopathy
- •Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
- •History of retinal detachment
- •Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.
- •Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
结局指标
主要结局
Residual Refractive Astigmatism
时间窗: 3 months
Residual refractive astigmatism measured in diopters
次要结局
- Corneal Astigmatism(3 months)
- Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)(3 months)
- Uncorrected Monocular Distance Visual Acuity(3 months)
- Spherical Equivalent Refraction(3 months)