Aphakia
Conditions
Keywords
aphakia, secondary intraocular lens, congenital cataract, marfan syndrome, pediatric cataract, ectopia lentis, subluxated lens
Brief summary
The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.
Interventions
Implantation of an intraocular lens
Sponsors
Ophtec USA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* 2 to 21 years of age * Have a visually significant cataract or need IOL replacement surgery * Compromised capsular bag prohibiting implantation of standard posterior IOL * Subject or parent/guardian must be able to comply with visit schedule and study requirements * Subject's legal representative must be able to sign the Informed Consent
Exclusion criteria
* Under 2 years of age * Unable to meet Postoperative evaluation requirements * No useful vision or vision potential in fellow eye * Mentally retarded patients * History of corneal disease * Abnormality of the iris or ocular structure * ACD less than 3.2 mm * Uncontrolled glaucoma * IOP \> 25 mmHg * Chronic or recurrent uveitis * Preexisting macular pathology that may complicate the ability to assess the benefit of this lens * Retinal detachment or family history * Retinal disease that may limit visual potential * Optic nerve disease that may limit visual potential * Diabetes mellitus * Pregnant, lactating or plan to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected distance visual acuity at 12 months postoperative | 5 years follow up | Determination of the ability of the lens to correct refractive error caused by aphakia |
Countries
Canada, United States
Outcome results
None listed