Clinical Study for Assessing the Visual Performance of Hanita Lenses New Trifocal Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation
研究概览
简要总结
Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.
详细描述
Device: Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL). Indication studied: The Hanita Lenses Trifocal IOL is intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near and intermediate visual functions, and reduced spectacle dependence.
Study description: This study is a prospective, single-arm single-center, open-label study.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 45 years and under 75 years.
- •Patients with bilateral age-related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
- •Patients with an axial length of 22-24.5mm.
- •Normal corneas with less than 0.75D of regular corneal astigmatism.
- •Post-operative best-corrected visual acuity projected to be 0.3 logMAR or lower.
- •Patient motivated for trifocal IOL after screening by the surgeon.
- •Fundus visualization is possible.
- •Absence of retinal or optic nerve diseases
- •Signed informed consent
排除标准
- •Previous ocular/corneal surgery that may affect refraction accuracy or visual acuity.
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- •History or evidence of any ocular disease that may affect visual acuity (i.e. uncontrolled glaucoma, ocular injury, corneal pathologies, retinal pathologies in general and macular pathologies in particular, diabetic retinopathy, uveitis, aniridia or iris atrophy, vitreous pathologies (patients with vitreous separation or floaters can be included).
- •Rubella cataract.
- •Amblyopia
- •Any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the trifocal lens.
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
- •Patients with pupil diameter greater than 4mm in photopic conditions.
- •Pregnant, lactating or planning to become pregnant during the course of the trial.
- •Allergy or intolerance to required study medications (including antibiotic).
- •Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days.
- •Traumatic cataract.
结局指标
主要结局
Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation
时间窗: 90-110 days post op
Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation
次要结局
- Contrast Sensitivity(90-110 days post op)
- patient satisfaction(90-110 days post op)
- Defocus Curve(90-110 days post op)