Phacoemulsification and Intraocular Lens Implantation: Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Corrected and Uncorrected Distance, Intermediate and Near Visual Acuity
研究概览
简要总结
The aim of the study is to create a patient registry that will allow for comparison of cataract treatment outcomes using phacoemulsification with implantation of different types of intraocular lenses.
详细描述
This study will establish a registry to evaluate outcomes associated with intraocular lens implants in patients undergoing cataract surgery. Retrospective assessments will include routinely collected preoperative, intraoperative, and postoperative data. Prospectively, visual acuity, refraction, examination findings, patient-reported outcomes, and complications will be collected for up to 60 months after surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone cataract surgery or are scheduled for bilateral cataract surgery with implantation of an extended-depth-of-focus (EDOF) intraocular lens, a monofocal-plus intraocular lens, or a standard monofocal intraocular lens.
排除标准
- •Anterior or posterior segment pathologies affecting postoperative visual acuity, including but not limited to: severe dry eye syndrome, corneal dystrophies, uveitis, retinal degenerative changes, glaucoma, or diabetic retinopathy.
- •Pseudoexfoliation syndrome
- •Keratoconus
- •History of laser refractive surgery
- •Prior ocular surgery other than cataract surgery
- •Amblyopia
- •Posterior capsule opacification
- •Postoperative best-corrected visual acuity (BCVA) less 0.5
- •Intraoperative complications, including posterior capsule rupture
结局指标
主要结局
Corrected and Uncorrected Distance, Intermediate and Near Visual Acuity
时间窗: Measured at the follow-up visit up to 60 months after cataract surgery
Distance, intermediate, and near visual acuity will be measured both uncorrected and corrected using standard ETDRS charts at 4 meters for distance, 66 cm for intermediate, and 40 cm for near visual acuity.
次要结局
- Objective Refraction(Measured at the follow-up visit up to 60 months after cataract surgery)
- Subjective Refraction(Measured at the follow-up visit up to 60 months after cataract surgery)
- Monocular and Binocular Defocus Curve(Measured at the follow-up visit up to 60 months after cataract surgery)
- Contrast Sensitivity(Measured at the follow-up visit up to 60 months after cataract surgery)
- Keratometry(Measured at the follow-up visit up to 60 months after cataract surgery)
- Anterior Chamber Depth(Measured at the follow-up visit up to 60 months after cataract surgery)
- Pupil Size(Measured at the follow-up visit up to 60 months after cataract surgery)
- Central Corneal Thickness(Measured at the follow-up visit up to 60 months after cataract surgery)
- Anterior Chamber Angle(Measured at the follow-up visit up to 60 months after cataract surgery)
- Patient-Reported Quality of Vision(Measured at the follow-up visit up to 60 months after cataract surgery)
- Primary and Secondary Spherical Aberrations(Measured at the follow-up visit up to 60 months after cataract surgery)
- Patient-Reported Spectacle Independence(Measured at the follow-up visit up to 60 months after cataract surgery)
研究者
Jakub Polinski
Ophthalmologist, Medical Doctor
Sensor Cliniq