Visual Performance of Different Types of Functional Intraocular Lenses in Cataract Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- best corrected distance visual acuity (BCVA)
研究概览
简要总结
This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the postoperative visual outcomes and quality of vision of two diffractive trifocal intraocular lenses (IOLs) in patients with high myopic cataracts.
详细描述
Binocular implantation of two types of trifocal IOLs was performed in patients with high myopic cataracts. Postoperative uncorrected distance (UNVA), intermediate (UIVA), near (UNVA), and best-corrected distance visual acuity (BCVA) were measured. Defocus curve, high-order aberrations, modulation transfer function curve, Strehl ratio and reading ability were compared between the two groups. The functional vision and incidence of photic phenomena were surveyed using questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •required binocular cataract extraction
- •age > 21 years
- •length of optic axis > 26 mm
排除标准
- •irregular corneal astigmatism > 0.3 um;
- •amblyopia; previous ocular surgery;
- •ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
- •requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study
研究组 & 干预措施
839MP group
Patients in this group were binocularly implanted with the AT LISA tri 839MP trifocal intraocular lens.
干预措施: trifocal intraocular lens (Device)
TFNT00 group
Patients in this group were binocularly implanted with the AcrySof IQ PanOptix TFNT00 trifocal intraocular lens.
干预措施: trifocal intraocular lens (Device)
结局指标
主要结局
best corrected distance visual acuity (BCVA)
时间窗: one year
corrected visual acuity at 5 m
uncorrected intermediate visual acuity (UIVA)
时间窗: one year
uncorrected visual acuity at 60 cm
uncorrected near visual acuity (UNVA)
时间窗: one year
uncorrected visual acuity at 40 cm
uncorrected distance visual acuity (UDVA)
时间窗: one year
uncorrected visual acuity at 5 m
次要结局
- objective visual quality(three months)
- HOAs(three months)
- Strehl Ratio(three months)