Artisan Aphakia Lens for the Correction of Aphakia in Children (NCT01547442) | Clinical Trial Compass
SuspendedNot Applicable
Artisan Aphakia Lens for the Correction of Aphakia in Children
United States300 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range2 Years – 21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Best corrected distance visual acuity at 12 months postoperative