Investigational Plan for the Clinical Study of the ARTISAN® Aphakia Lens for the Correction of Aphakia in Children
Study Sponsor: OPHTEC USA, Inc.
Principal Investigator: Yasmin Bradfield, MD
Study Coordinator: Kris Dietzman
The objective of this clinical investigation is to determine the effectiveness of the ARTISAN® Aphakia lens in the treatment of aphakia and to precisely define the associated risks and, if possible, identify particular groups of patients who may be at high risk of developing complications resulting from the surgical procedure of implanting an ARTISAN® Aphakia lens.
The objectives of this study are:
1. To determine postoperative best corrected visual acuity of patients receiving an ARTISAN® Aphakia lens.
2. To determine the occurrence and time course of postoperative complications and adverse events for the ARTISAN® Aphakia lens.
3. To identify groups within the implant population that are at high risk of developing complications.
Implantation of the ARTISAN® Aphakia lens may be indicated in the following conditions:
1. Patients 2 to 21 years old at the time of the baseline visit, of either sex, and of any race that have a visually significant cataract (in preoperative phakic eyes), need IOL replacement surgery (in preoperative aphakic or pseudophakic eyes), or have a subluxated capsule, weakened zonules or otherwise compromised capsular bag prohibiting implantation of a standard posterior chamber IOL such as in Marfan’s syndrome, ectopia lentis or other pathology.
2. Subject’s legally authorized representative (parent or guardian) must be able to understand and sign the informed consent form that has been approved by the Institutional Review Board. Assent to participate in the study should be obtained from patients over 11 years to 21 years of age is possible unless not allowed by local regulations.
3. Parent or guardian must agree to comply with the visit schedule and other requirements of the study.
For more information contact Kris Dietzman at 608-263-9035