Clinical Study of the ARTISAN® Aphakia Lens for the Correction of Aphakia in Adults
|Principal Investigator: AlanCrandall|
|Keywords: Aphakia , Intraocular lens||Department: Ophthalmology-Services|
|IRB Number: 00062505||Co Investigator:|
|Specialty: Ophthalmology, Ophthalmology|
|Sub Specialties: Cataract Surgery, Comprehensive Ophthalmology|
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:
A. To determine postoperative distant visual acuity of patients receiving an ARTISAN® Aphakia Lens.
B. To determine the occurrence and time course of postoperative complications and adverse events for the ARTISAN® Aphakia Lens.
C. 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 who are 22 years old or older at the time of the baseline visit of either sex and of any race who have a visually significant cataract (if preoperative phakic eyes) or IOL replacement surgery (in preoperative aphakic of pseudophakic eyes), subluxated capsule, weakened zonules or otherwise compromised capsular bag prohibiting implantation of a standard posterior chamber IOL such as in Marfan’s syndrome, ecotpia lentis or other pathology.
2. Patient must agree to comply with the visit schedule and other requirements of the study.
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. The following are criteria for fellow eye implantation:
1. A minimum of one week following the initial implant.
2. No adverse events of sight-threatening complications caused by the lens in the initial eye.
3. An investigator must obtain a prospective protocol waiver from the governing Institutional Review Board (IRB) if he/she believes that a bilateral implant is warranted prior to one week following the initial implant.
The physician should determine whether any of the following circumstances may create an undue risk when considering implanting an ARTISAN® Aphakia Lens. Investigators considering implantation in such patients should explore the use of alternative methods of correction and consider lens implantation only if alternatives are deemed unsatisfactory to meet the needs of the patient:
1. Patients that are not able to meet the extensive postoperative evaluation requirements
2. Mentally retarded patients
3. When the patient has no useful vision or vision potential in the fellow eye
4. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
5. Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
6. Patients with an anterior chamber depth less than 3.2mm
7. Patients with uncontrolled glaucoma
8. High preoperative intraocular pressure( >25 mmHg)
9. Chronic or recurrent uveitis or history of the same
10. Pre-existing macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
11. Patients with a retinal detachment or a family history of retinal detachment
12. Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt’s retinopathy
13. Optic nerve disease that may limit the visual potential of the eye
14. Diabetes mellitus
15. Pregnant, lactating, or plans to become pregnant during the course of this study