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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

Abraham Farhan

561-989-8767

abraham.farhan@usa.ophtec.com

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: