Aphakia
Conditions
Keywords
aphakia, secondary intraocular lens
Brief summary
This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.
Detailed description
Not desired
Interventions
Implantation of lens to correct refractive error in aphakic eye
Sponsors
Ophtec USA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated. * Patient must agree to comply with the visit schedule and other requirements of the study
Exclusion criteria
* Patients that are not able to meet the extensive postoperative evaluation requirements * Mentally retarded patients * When the patient has no useful vision or vision potential in the fellow eye * History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision. * 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 * Patients with uncontrolled glaucoma * High preoperative intraocular pressure, \>25 mmHg * Chronic or recurrent uveitis or history of the same * Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens * Patients with a retinal detachment or a family history of retinal detachment * Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye * Diabetes mellitus * Pregnant, lactating, or plans to become pregnant during the course of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in best corrected visual acuity | 3 year follow up |
Countries
Canada, United States
Outcome results
None listed