Artisan Aphakia Lens for the Correction of Aphakia in Children

Overview

About this study

To determine the effectiveness of the ARTISAN Aphakia lens in the treatment of aphakia and to precisely define the associated risks and, if possible, identify particular groups of patients who may be at high risk of developing complications resulting from the surgical procedure of implanting an ARTISAN Aphakia lens.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Erick Bothun, M.D.

Open for enrollment

Contact information:

Suzanne Wernimont CCRP

(507) 538-8119

Wernimont.Suzanne@mayo.edu

More information

Publications

Publications are currently not available
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