Prospective, multicenter, post-marketing study to evaluate the effectiveness of a monofocal implantable phakic contact lens (IPCL) in myopic and hyperopic patients, with and without astigmatism

Care Group, India0 个研究点目标入组 40 人开始时间: 2021年2月24日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Baseline Refractive Errors between +2.00D and +6.50D and -6.00D and -30.00D of myopia/hyperopia
•Stable refraction for 12 months before study enrollment
•Contact lens not worn for at least 2 weeks (rigid and toric contact lenses) or 3 days (soft contact lenses) prior to the first refraction
•Patients with a BSCVA of at least 20/40
•All patients to be enrolled in the study will be between 21 and 45 years old
•Patients willing to have IPCL implanted in both eyes
•Patient should be able to comply with the standardized post-operative follow-up visits through the 3-year study period
•Patient able to give consent

•Anterior Chamber depth < 2.8 mm
•Endothelial Cell Density (ECD) less than 2000 cells / mm3
•History and/or clinical signs of iritis/uveitis, diabetic retinopathy, glaucoma, previous ocular surgery, ocular hypertension, progressive sight-threatening disease other than myopia, pseudoexfoliation, and/or insulin- dependent diabetes, keratoconus, monocular vision
•Patient is pregnant, plans to become pregnant or is lactating during the course of the study, or has any condition associated with the fluctuation of hormones that could lead to refractive changes
•Participation in other clinical trials

发起方

Care Group, India