Clinical Evaluation of the Aspheric SeeLens AF Intra-ocular Lens.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Best corrected visual acuity 3 months after SeeLens AF implantation
研究概览
简要总结
Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation. The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and secondary cataract formation rate.
Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp examination and biometry.
Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm), phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation parameters will be evaluated by the surgeon.
Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction and comprehensive slit lamp examinations up to 3 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Senile Cataract
- •Age >18 years
- •Cataract extraction using phacoemulsification
- •Corneal incision less than 1.5 mm
排除标准
- •Allergy/sensitivity to eye drops used during and after cataract surgery
- •Amblyopia/ strabismus
- •Ocular disease, other than cataract, diminishing visual acuity, such as corneal opacity, advanced glaucoma, diabetic retinopathy, exudative or moderate to severe non-exudative age-related macular degeneration, uveitis.
- •previous ocular surgery or ocular trauma in the investigated eye
- •Ocular anomaly, such as microphthalmos
- •Keratometry values less than 40 diopters or more than 47 diopters.
- •Ocular axial length less than 21.0 mm or longer than 25.0 mm
- •Intra-operative complications prior to intraocular lens implantation, such as tear of the posterior capsule.
- •posterior capsular scar
- •visual acuity in the fellow eye less than 20/200
结局指标
主要结局
Best corrected visual acuity 3 months after SeeLens AF implantation
时间窗: 3 months
次要结局
- Complications related to SeeLens AF implantation during cataract surgery.(3 months)
- Prediction of ocular refraction after cataract surgery with Seelens AF implantation(3 months)
- Postoperative severe intra-ocular inflammation or infection(3 months)