A Randomized, pilot study, subject-masked comparison of visual function after bilateral implantation of Presbyopia-correcting IOLs - M10-070

Alcon Laboratories0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Subjects are eligible for the study if they meet the following criteria:
•Note: Ocular criteria must be met in both eyes.
•* are willing and able to understand and sign an informed consent;
•* * 1.00 Dioptres of corneal astigmatism in both eyes
•* are willing and able to attend postoperative examinations per protocol schedule;
•* are at least 21 years of age, of either gender and any race;
•* require cataract extraction followed by posterior IOL implantation used as an on-label procedure;
•* be willing to have second eye surgery within one month of first eye surgery; Note: The second eye surgery should not be performed less than one week (7 days) after the first eye surgery.
•* are in good ocular health, with the exception of cataracts;
•* are free of disease(s)/condition(s) listed in the *Caution* section of the AcrySof® ReSTOR® +3 and LENTIS® Mplus package inserts

•* Planned multiple procedures, including LRI, during cataract/IOL implantation surgery
•* Amblyopia
•* Previous corneal surgery
•* Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy)
•* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
•* Diabetic retinopathy
•* Macular degeneration
•* Subjects with pupil abnormalities (e.g., corectopia)
•* History of retinal detachment
•* Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
•* suturing of incision required at time of surgery

发起方

Alcon Laboratories