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The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artisan Aphakia Intraocular Lens | Experimental | Implantation of an Artisan intraocular lens to correct aphakia in children |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artisan Aphakia Intraocular Lens | Device | Implantation of an intraocular lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected distance visual acuity at 12 months postoperative | Determination of the ability of the lens to correct refractive error caused by aphakia | 5 years follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abraham Farhan | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 35016 | United States | ||
| The Vision Center |
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| Los Angeles |
| California |
| 90027 |
| United States |
| Indiana University, Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Harvard University, Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Minnesota, MN Lions Children's Eye Clinic | Minneapolis | Minnesota | 55454 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Children's Mercy Hospital and Clinics | Kansas City | Missouri | 64111 | United States |
| Washington University, St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Rosenthal Eye and Facial Plastic Surgery | Great Neck | New York | 11023 | United States |
| New York Medical College, Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Nationwide Children's Hospital, Pediatric Ophthalmology Associates | Columbus | Ohio | 43205 | United States |
| University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital | Mayfield Heights | Ohio | 44124 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina, Storm Eye Institute | Charleston | South Carolina | 29425 | United States |
| University of Texas, Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Texas, Robert Cizik Eye Clinic | Houston | Texas | 77030 | United States |
| Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| Credit Valley Eyecare | Mississauga | Ontario | L5L 1W8 | Canada |
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D008382 | Marfan Syndrome |
| D004479 | Ectopia Lentis |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005124 | Eye Abnormalities |
| D007906 | Lens Subluxation |
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