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.
Conditions
Aphakia
Recruitment Status
Recruiting
Eligibility Criteria
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
Intervention
Intervention Type
Intervention Name
Device
Artisan Aphakia Intraocular Lens
Phase
Phase 3
Gender
All
Min Age
2 Years
Max Age
21 Years
Download Date
June 27, 2022
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: