Clinical Investigation of the Visual Outcomes and Safety After Bilateral Implantation of a Trifocal Presbyopia Correcting IOL in a Korean Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Binocular Defocus Curve at Month 3
研究概览
简要总结
The purpose of this study is to confirm the effectiveness of the investigational lens in a Korean population, especially for visual performance, quality of vision, and subject satisfaction with the visual outcome, as well as the safety of the lens. This trial will be conducted in Korea.
详细描述
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 study visits over a 4-5-month period. Of these 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 3 visit (Day 90-120 post second eye implantation). The second eye implantation will occur 2-30 days after the first implantation.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requires cataract extraction in both eyes
- •Clear intraocular media other than cataracts in both eyes
- •Calculated lens power between +16.0 and +24.0 diopter (D)
- •Preoperative OR expected postoperative regular corneal astigmatism of < 1.00 D.
排除标准
- •Pregnant or lactating
- •Any clinically significant corneal abnormality, per the Investigator's expert medical opinion
- •Previous corneal transplant; previous ocular trauma; previous refractive surgery
- •History of, concurrent, or predisposition to retinal conditions, such as diabetic retinopathy, diabetic macular edema, or macular degeneration.
研究组 & 干预措施
Multifocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes will be implanted.
干预措施: AcrySof IQ PanOptix Multifocal IOL (Device)
结局指标
主要结局
Binocular Defocus Curve at Month 3
时间窗: Month 3 (Day 90-120 post second eye implantation)
The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. The visual acuity (VA) at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned.
次要结局
- Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)(Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation))
- Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)(Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation))
- Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm)(Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation))
- Binocular Photopic Best Corrected Contrast Sensitivity Without Glare(Month 3 (Day 90-120 post second eye implantation))
- Binocular Defocus Curve at Month 1(Month 1 (Day 30-60 post second eye implantation))
- Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)](Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation))
- Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)](Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation))
- Binocular Photopic Best Corrected Contrast Sensitivity With Glare(Month 3 (Day 90-120 post second eye implantation))
- Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs)(Preoperative and Month 3 (Day 90-120 post second eye implantation))
- Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)(Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation))
- Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)(Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation))