Artisan Aphakia Lens for the Correction of Aphakia in Children
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-004260
NCT ID: NCT01547442
Sponsor Protocol Number: 17-004260
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Erick Bothun, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available