NCT02691741已完成不适用
Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 主要终点
- Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
研究概览
简要总结
The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.
详细描述
Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bilateral cataracts with planned clear cornea cataract removal;
- •Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- •Calculated lens power between 13.0 and 30.0 Diopters (D);
- •Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye;
- •Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial;
- •Preoperative regular corneal astigmatism of < 1.00 D, in both eyes;
- •Clear intraocular media other than cataract in both eyes;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);
- •Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
- •Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
- •Amblyopia;
- •Previous corneal transplant;
- •Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction;
- •Rubella, congenital, traumatic, or complicated cataracts;
- •Glaucoma (uncontrolled or controlled with medication);
- •Degenerative eye disorders;
- •History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy;
- •Optic nerve atrophy;
- •Expected to require retinal laser treatment;
- •Color vision deficiencies;
- •Pregnant or lactating (current or planned during the course of the study);
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
时间窗: Day 120-180 from second eye implantation
VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA 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 ETDRS chart. A lower numeric value represents better visual acuity.
次要结局
- Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180(Day 120-180 from second eye implantation)
- Mean Photopic Binocular Defocus Curve at Day 120-180(Day 120-180 from second eye implantation)
- Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180(Day 120-180 from second eye implantation)
- Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180(Day 120-180 from second eye implantation)
- Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180(Day 120-180 from second eye implantation)
- Subject Satisfaction Recorded at Day 120-180(Day 120-180 from second eye implantation)
- Least Squares Mean Binocular UCIVA (60cm) at Day 120-180(Day 120-180 from second eye implantation)
- Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180(Day 120-180 from second eye implantation)
- Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180(Day 120-180 from second eye implantation)
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