NCT06428955已完成4 期
Prospective Multicenter Evaluation of the Visual Performance of a Non-constant Aberration Correcting Aspheric Monofocal Intraocular Lens (Precise Study)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Monocular best corrected distance visual acuity (CDVA)
研究概览
简要总结
The aim of this study is to investigate the 3-month visual performance of the CT LUCIA 621P IOL, a hydrophobic aspheric monofocal IOL with a non-constant aspheric optic profile in adult patients 50 years of age or older who are undergoing cataract surgery.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 50 years of age or older, male or female, of any race or ethnicity.
- •Presenting for uncomplicated bilateral cataract surgery for age-related cataract.
- •Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS).
- •Bilateral implantation of a CT LUCIA 621P IOL with a dioptric power between +10.00 D and +30.00 D and a target postoperative refraction of emmetropia (0.00 ±0.50 D).
- •Clear intraocular media other than cataract (i.e. no hyphema, vitreous hemorrhage)
- •No visual acuity limiting pathologies other than cataract. Best corrected postoperative visual acuity potential of 20/25 or better in both eyes as estimated by potential acuity meter or surgeon estimation.
- •Provide written informed consent and a signed HIPPA form.
- •Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.
排除标准
- •Corneal Astigmatism of >1.0 D.
- •Planned monocular cataract extraction.
- •Visual field loss which has an impact on visual acuity.
- •Subjects with intraoperative surgical complications in whom a CT LUCIA 621P IOL cannot be implanted.
- •History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, keratoconus, strabismus, uncontrolled glaucoma)
- •History of Glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.
- •Previous intraocular or corneal surgery, including all forms of refractive surgery that might confound the outcome of the investigation or increase the risk to the subject
- •Previous anterior or posterior chamber surgery other than peripheral retinal barrier laser, SLT/ALT (e.g., vitrectomy, laser iridotomy)
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions).
- •Capsular or zonular abnormalities or other conditions that increase the risk of zonular rupture during cataract extraction procedure and/or may affect the postoperative centration or tilt of the lens
- •Use of a systemic or ocular medication that might affect vision and confound the outcome or increase the risk to the subject in the opinion of the investigator such as tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)
- •Cycloplegic pupil diameter <6.0 mm or the presence of ocular implants that limit pupil diameter (malyugin rings; iris prosthesis).
- •Usage of contact lenses during study participation
- •Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes
- •Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for study participation, may increase the operative risk or may confound the outcome of the study.
研究组 & 干预措施
Bilateral implantation of investigational device
Experimental
Monofocal IOL
干预措施: CT LUCIA 621P (Device)
结局指标
主要结局
Monocular best corrected distance visual acuity (CDVA)
时间窗: Three (3) Months
The primary efficacy endpoint is the proportion of patients with monocular CDVA of 20/40 or better at three months
次要结局
- Binocular Corrected Distance Visual Acuity(Three (3) Months)
- Monocular Uncorrected Distance Visual Acuity(Three (3) Months)
- Monocular Distance Corrected Intermediate Visual Acuity(Three (3) Months)
- Monocular Uncorrected Intermediate Visual Acuity(Three (3) Months)
- Refractive Stability(Three (3) Months)
- Manifest Refraction Spherical Equivalent(Three (3) Months)
- Refractive Predictability(Three (3) Months)
- Contrast Sensitivity - mesopic and photopic with and without glare(Three (3) Months)
研究者
研究点 (5)
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