Prospective Clinical Trial of Unilateral or Bilateral Implantation of the Enlarged Depth-of-focus Intraocular Lens in Cataract Patients With Presbyopia
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of visual acuity at near, intermediate and far
研究概览
简要总结
This is to evaluate the satisfaction of patient and physician about short-distance, medium-distance, long-distance postoperative vision and eyeglass dependence, glare, and visual acuity after insertion of the TECNIS® Symfony or TECNIS® Symfony Toric intraocular lens.
详细描述
The patients underwent uneventful phacoemulsification and implantation of TecnisSymfony®. Mean absolute error (MAE) at 1 month was compared in SRK/T, Holladay2, Haigis, Hoffer Q, Barrett Universal II, and Hill-RBF formula. At postoperative 1, 4, and 12 weeks, logMAR visual acuity (logMARVA) at the distance (5m), intermediate (66cm), and near (40cm), and spherical equivalent (SE) in manifested refraction (MR) and automated refraction (AR) were measured. Wavefront aberration, contrast sensitivity test, and glare test were done at 12 weeks. The questionnaire was used to investigate glare, glasses dependency, and patient satisfaction at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral or bilateral cataract
- •Sixteen years and older
- •Regular corneal topography and corneal astigmatism
- •Corneal astigmatism 0.75 Diopter and less for TECNIS® Symfony IOL, and between 1.0 and 3.62 Diopter for TECNIS® Symfony toric IOL
排除标准
- •Pregnant or nursing women
- •In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Malfan syndrome, etc.)
- •White cataract
- •Patients who need intraocular lens outside of range
- •In the presence of other ocular diseases that is expected to have a poor final visual acuity of less than 20/30 after surgery (amblyopia, strabismus, keratoconus, etc.)
- •Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- •Patients using systemic or ocular medication that affect visual acuity.
- •Patients who had previously undergone refractive surgery.
- •Patients participating in other clinical trials during the study.
研究组 & 干预措施
TecnisSymfony intraocular lens insertion group
干预措施: TecnisSymfony® (Device)
结局指标
主要结局
Change of visual acuity at near, intermediate and far
时间窗: preoperative(last outpatient follow-up before the surgery), 1 month after surgery, 3 months after surgery.
LogMAR visual acuity (logMARVA) at the distance (5m), intermediate (66cm), and near (40cm) were measured at preoperative (last outpatient follow-up before the surgery), postoperative 1, 4, and 12 weeks.
次要结局
- Spectacle dependence evaluation by questionnaire(One month and three months after the surgery.)
- Photic phenomena evaluation by questionnaire.(One month and three months after the surgery.)
研究者
Mee Kum Kim
Professor
Seoul National University Hospital