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Investigational Plan for the Clinical Study of the ARTISAN® Aphakia Lens for the Correction of Aphakia in Children
Study ID: STU 082013-072
The proposed study is a prospective, open-label, non-randomized, multicenter clinical evaluation comprised of a cohort population of 300 patients. up to 390 patients will be enrolled to account for possible lost to follow-up from up to 20 investigational sites. Patients will be followed for a minimum of five (5) years postoperatively. Patient population will consist of patients from 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.During the study, all protocols and guidelines mustbe followed, i.e. patient enrollment criteria, investigator qualifications, number of patients to be entered into the study, and postoperative reporting periods. Visit schedule will consist of: Preoperative (within 30 days of the planned operation),operative visit,Visit 1: 1-2 Days Postoperatively, Visit 2: 7-14 Days Postoperatively, Visit 3: 30-60 Days Postoperatively, Visit 4: 90-120 Days Postoperatively, Visit 5: 160-200 Days Postoperatively, Visit 6: 330-420 Days Postoperatively, Visit 7: 630-780 Days Postoperatively, Visit 8: 990-1140 Days Postoperatively, Visit 9: 1350-1500 Days Postoperatively, and Visit 10: 1710-1860 Days Postoperatively. When at least 300 patients have been evaluated at their 12 month examination, the data will be reviewed and evaluated by the Sponsor's Medical Monitor and may be submitted to the FDa Review Staff for Premarket approval consideration. Fellow eye implantation of patients will be allowed following stabilization of the first eye. although the second eye will be under the same requirements as the first eye, data from the second eye will not contribute to the cohort population or the primary analysis.
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[Single Quote]s syndrome, ectopia lentis or other pathology. 2. Subject[Single Quote]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. According to the UTSW IRB policy, assent to participate in the study will be obtained from all children from the age of 10 through 17. 3. Parent or guardian must agree to comply with the visit schedule and other requirements of the study.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- Serena Xiaohong Wang
OPHTEC USA INC
Eye and Orbit