Clinical Evaluation of the Vivinex IOL - PHIV-101-SP2

HOYA Surgical Optics GmbH0 个研究点目标入组 89 人开始时间: 2017年8月18日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Minimum 18 years of age
•2.Bilateral clinically significant cataracts for which phacoemulsification extraction and posterior chamber IOL implantation has been planned
•3.By surgeon discretion best corrected distance visual acuity projected to be better than 20/40 (0.5) following cataract removal and IOL implantation
•4.Clear intraocular media other than cataract
•5.Signed informed consent

•1. Requiring an intraocular lens outside the commercially available spherical power range
•2.Presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) which at surgeon’s discretion will likely effect study outcomes
•3.Previous corneal or intraocular surgery which at surgeon’s discretion will likely effect study outcomes
•4.Present corneal or intraocular pathology including pseudo-exfoliation which at surgeon’s discretion will likely effect study outcomes or may require surgical intervention during the course of the study.
•5.Inability to achieve keratometric stability for contact lens wearers
•6.Intraoperative complications which at surgeon’s discretion may lead to IOL decentration
•7.Use of systemic or ocular medications which at surgeon’s discretion will likely effect study outcomes
•8.Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
•9.Patient is pregnant, plans to become pregnant, is breastfeeding or has another condition associated with the fluctuation of hormones that could lead to refractive changes
•10.Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical trial.

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