Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- monocular and binocular visual acuity
研究概览
简要总结
This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens（IOLs） in cataract patients.
详细描述
The subjects will undergo uneventful phacoemulsification and implantation of IOL.
The subjects will be divided into two groups . The unilateral cataract patients in the Group 1 will undergo unilateral surgery, and the bilateral cataract patients in the Group 2 will undergo bilateral surgery. IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition. In each group, the subjects will be divided into three subgroups according to the type of the IOLs.Compare binocular functional vision and the satisfaction of patient between the two groups at postoperative 3 months.Compare binocular functional vision and the satisfaction of patient with different IOLs among the subgroups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 with unilateral or bilateral age related cataracts
- •Regular corneal topography and Preoperative 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.)
- •Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- •History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
- •Patients with history of ocular trauma or prior ocular surgery including refractive procedures
- •postoperative visual acuity of worse than 0.2 logMAR in any eye
- •Patients using systemic or ocular medication that affect visual acuity.
- •Patients participating in other clinical trials during the study.
结局指标
主要结局
monocular and 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
- Fusion function(3 months postoperatively)
- Binocular Contrast sensitivity(3 months postoperatively)
- Subjective visual quality(3 months postoperatively)
- Binocular Defocus Curve(3 months postoperatively)
- stereopsis(3 months postoperatively)