Clinical Handleability and Acceptability Assessment of the New Modular Cartridge Delivery System - IDEV-120-TTA

Johnson and Johnson Surgical Vision, Inc.0 个研究点目标入组 84 人开始时间: 2018年6月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Minimum 22 years of age
•Unilateral or bilateral cataracts for which IOL implantation are planned
•Planned small-incision cataract surgery with implantation of a TECNIS® 1-piece IOL, Model ZCB00 in the diopter range of +16.00 to +28.00
•Clear intraocular media, other than cataract
•Availability, willingness and sufficient cognitive awareness to comply with examination procedures
•Ability to understand, read, and write English.
•Signed informed consent and documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries

•Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D
•Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)
•Recent ocular trauma or ocular surgery that is not resolved/stable or may increase risk to the subject
•Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
•Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
•Poorly-controlled diabetes
•Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes is acceptable.
•Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial

发起方

Johnson and Johnson Surgical Vision, Inc.