A Comparative Study on Postoperative Visual Quality: New Domestic Trifocal IOL (D615L) Versus Zeiss AT LISA Tri 839MP
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- UIVA
研究概览
简要总结
The goal of this prospective cohort study is to compare visual quality after cataract surgery in patients implanted with a new domestic trifocal intraocular lens (D615L) versus the Zeiss AT LISA tri 839MP. The main question it aims to answer is: Is the uncorrected distance, intermediate, and near visual acuity achieved with D615L non-inferior or superior to that achieved with the Zeiss 839MP? Participants diagnosed with age-related cataract will undergo phacoemulsification and receive one of the two intraocular lenses. They will attend follow-up visits where uncorrected visual acuity, defocus curves, and the VF-14 questionnaire will be assessed over a follow-up period of at least 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed age-related cataract;
- •preoperative corneal astigmatism <1.0 D;
- •endothelial cell count >2000/mm²;
- •signed informed consent and ability to complete 6-month follow-up
排除标准
- •prior corneal refractive, glaucoma or vitreoretinal surgery;
- •intraoperative posterior capsule rupture, zonular dehiscence or vitreous loss;
- •corneal pathology, macular edema or optic neuropathy affecting visual assessment;
- •active ocular inflammation, glaucoma, maculopathy or diabetic retinopathy;
- •uncontrolled systemic disease such as diabetes or autoimmune disorders.
研究组 & 干预措施
839MP
implanted 839MP IOL
D615L
implanted D615L IOL
干预措施: Trifocal IOL (Other)
结局指标
主要结局
UIVA
时间窗: From enrollment to the end of treatment at 6 months
uncorrected-intermediate visual acuity
次要结局
未报告次要终点
研究者
Sun Yilin
resident physician of Ophthalmology
Shanghai 10th People's Hospital