Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- binocular visual acuity
研究概览
简要总结
This is to compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（IOL） in one eye and mild cataract in the fellow eye.
详细描述
The subjects are the patients who underwent monocular IOL implantation before and present mild cataract in the fellow eye.Compare preoperative and postoperative the binocular functional vision and the satisfaction of patients when the patients ask for the surgery (phacoemulsification and IOLs implantation)on the fellow eye. The type of IOLs maybe according to the patients preference and the eyes condition.The subjects will be divided into three groups according to the type of the IOLs，including monofocal group,bifocal group,and trifocal group.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had monocular intraocular lens in one eye with mild cataract in the fellow eye ask for the cataract surgery in the fellow eye
- •Regular corneal topography and corneal astigmatism ≤ 0.75 Diopter
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, Marfan syndrome, etc.)
- •In the presence of other ocular diseases that is expected to have a poor final visual acuity of worse than 0.2 logMAR 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 with history of ocular trauma or prior ocular surgery including refractive procedures
- •Patients participating in other clinical trials during the study.
结局指标
主要结局
binocular visual acuity
时间窗: 3 months postoperatively
uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity will be measured at 5m, 80cm and 40cm respectively. All visual acuity measurements will be conducted under photopic conditions (85 cd/m2) and at 100% contrast
次要结局
- Binocular Contrast sensitivity(3 months postoperatively)
- Binocular Defocus Curve(3 months postoperatively)
- stereopsis(3 months postoperatively)
- Fusion function(3 months postoperatively)
- Subjective visual quality(3 months postoperatively)