Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- monocular and binocular visual acuity
研究概览
简要总结
Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens(IOLs) implantation designed for the correction of presbyopia.
详细描述
Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens Implantation designed for the correction of presbyopia.The subjects will undergo bilateral uneventful phacoemulsification and implantation of IOL.The subjects will be divided into several groups according to the type of the IOLs，including monofocal IOL group,monovision designed group ，bifocal IOL group, mix bifocal IOL group，trifocal IOL group，Exteded Depth of Focus(EDOF) IOL group and blend vision group. Compare the Subjective and objective visual quality and economic efficiency among these groups at 3 months postoperatively.
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
- 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 bilateral cataract
- •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
economic efficiency
时间窗: 3 months postoperatively
economic efficiency was defined as the ratio of objective spectacle independence (UCVA better than 0.10 logMAR) and IOL price, then compare the economic efficiency among different groups.
次要结局
- Binocular Defocus Curve(3 months postoperatively)
- Binocular Contrast sensitivity(3 months postoperatively)
- stereopsis(3 months postoperatively)
- Subjective visual quality(3 months postoperatively)
- Fusion function(3 months postoperatively)