Ocular Clarity After Cataract Surgery With Two Different Phacoemulsification Systems
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 主要终点
- Straylight
研究概览
简要总结
The goal of this study is to study the restoration of quality of vision, expressed as straylight, in the immediate period after cataract surgery with two different phacoemulsification technologies.
详细描述
Cataract is an opacification of the lens. With cataract surgery, the lens is surgically removed after which a clear artificial intraocular lens is implanted. For patients, it is important that they regain functional vision as quickly as possible after surgery as a limited vision may increase the risk of falling and increases the dependency on other people. Surgical removal of the lens is done with a phacoemulsification system. Differences between phacoemulsification systems are the used pump type, the way the needle oscillates, and the fluid dynamics of the system. It is unknown whether any of the available systems offer an advantage on the amount of corneal oedema that develops after surgery and, therefore, results in a more rapid restoration of functional vision.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cataract in both eyes,
- •Having consented to and is planned to undergo cataract surgery in both eyes,
- •Planned for implantation of a non-toric monofocal intraocular lens (IOL) in both eyes,
- •A targeted refractive error of emmetropia,
- •Corneal astigmatism of ≤1.5 D,
- •Age of at least 18 years,
- •Willing and able to participate in both preoperative and postoperative examinations, and
- •Agreeing to sign the informed consent form.
排除标准
- •Insufficient understanding of the Dutch language to comply with study procedures,
- •Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, significant glaucoma, significant diabetic eye disease, significant ocular surface disease, cornea dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident,
- •Subjects with a history of ocular surgery (e.g., corneal refractive surgery),
- •Subjects with an increased risk of complicated cataract surgery:
- •Lens subluxation or (phaco)iridodonesis,
- •Cataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract, and
- •History of ocular trauma,
- •Unability to be (reliably) measured with the C-Quant straylight meter or Pentacam corneal topographer, and
- •A calculated IOL power in any eye that prohibits implantation of the same type of IOL in both eyes.
结局指标
主要结局
Straylight
时间窗: 1 month after surgery
Amount of straylight measured with C-Quant, expressed as log(s)
次要结局
- Corneal densitometry(1 month after surgery)
- Total surgery time(Surgery day)
- Corneal pachymetry(1 week after surgery)
- Patient-Perceived Satisfactory Improvement in Vision(1 month after surgery)
- Amount of phaco energy used(Surgery day)
- Amount of balanced salt solution used(Surgery day)
- Presence of corneal oedema(1 month after surgery)
- Catquest-9SF(1 month after surgery)
- Uncorrected Distance Visual Acuity(1 month after surgery)
- Corrected Distance Visual Acuity(1 week after surgery)
研究者
Nic J. Reus, MD, PhD
Principal Investigator
Amphia Hospital