A multicenter prospective clinical trial to evaluate the safety and effectiveness of the CT LUCIA 611P posterior chamber intraocular lens for correction of aphakia following cataract removal

HS 2018-4279
Eye
Sumit (Sam) Garg, MD
UCI Health Gavin Herbert Eye Institute, 850 Health Sciences Road, Irvine, CA 92697
This single-arm clinical trial uses a posterior chamber intraocular lens, the CT LUCIA 611P, for the correction of aphakia following extracapsular cataract extraction via phacoemulsification in adult patients, and the purpose is to establish the safety and effectiveness of the CT LUCIA 611P.
  • You must be 22 years of age or older at the time of study enrollment.
  • You must have a visually significant cataract in the study eye for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated.
  • If you wear a rigid gas permeable (RGP) contact lens in the study eye, you must be willing to discontinue lens wear for ≥ 30 days prior to preoperative biometry.
  • You must be available, willing and have sufficient cognitive awareness to return for study-required visits and comply with examination procedures.
  • You must meet all other eligibility criteria.
If you choose to take part in this clinical trial and are eligible, your participation will last approximately 13 months. You would have to attend a preoperative screening visit, which must occur no more than three (3) months prior to surgery to determine if you qualify to take part in the study. If you qualify at the preoperative screening, you will undergo cataract removal surgery and planned implantation of the study device. During the 12 months after cataract surgery, you would have to return for five (5) follow-up visits.
Participation in this trial may help evaluate the performance of the study device. Taking part in a clinical trial is entirely voluntary. It is important that you take your time to decide whether you want to participate. If you decide to participate, you can change your mind at any time.
You will be compensated for your time and inconvenience related to your study participation, and will receive up to a total of $300 USD for completing the study. You will be paid $50 USD for each completed visit (pre-operative visit, and five follow-up visits).
Rosie Magallon, senior clinical research coordinator, or Rachel R. Lane, assistant clinical research coordinator, Department of Ophthalmology, UCI School of Medicine
949-824-8297
949-824-0429