Artisan Aphakia Lens for the Correction of Aphakia in Children
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01547442 |
Recruitment Status :
Recruiting
First Posted : March 7, 2012
Last Update Posted : February 2, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aphakia | Device: Artisan Aphakia Intraocular Lens | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Artisan Aphakia Lens for the Correction of Aphakia in Children |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Artisan Aphakia Intraocular Lens
Implantation of an Artisan intraocular lens to correct aphakia in children
|
Device: Artisan Aphakia Intraocular Lens
Implantation of an intraocular lens |
- Best corrected distance visual acuity at 12 months postoperative [ Time Frame: 5 years follow up ]Determination of the ability of the lens to correct refractive error caused by aphakia

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547442
Contact: Fred Wassenburg | 561-989-8767 | f.wassenburg@ophtec.com |
United States, Indiana | |
Indiana University, Riley Hospital for Children | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Johns Hopkins Wilmer Eye Institute | Recruiting |
Baltimore, Maryland, United States, 20814 | |
United States, Massachusetts | |
Harvard University, Boston Children's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
University of Minnesota, MN Lions Children's Eye Clinic | Recruiting |
Minneapolis, Minnesota, United States, 55454 | |
United States, Missouri | |
Children's Mercy Hospital and Clinics | Recruiting |
Kansas City, Missouri, United States, 64111 | |
Washington University, St. Louis Children's Hospital | Recruiting |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Rosenthal Eye and Facial Plastic Surgery | Recruiting |
Great Neck, New York, United States, 11023 | |
New York Medical College, Westchester Medical Center | Recruiting |
Valhalla, New York, United States, 10595 | |
United States, Ohio | |
Nationwide Children's Hospital, Pediatric Ophthalmology Associates | Recruiting |
Columbus, Ohio, United States, 43205 | |
University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital | Recruiting |
Mayfield Heights, Ohio, United States, 44124 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15224 | |
United States, South Carolina | |
Medical University of South Carolina, Storm Eye Institute | Recruiting |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
University of Texas, Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
University of Texas, Robert Cizik Eye Clinic | Recruiting |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Moran Eye Center | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Canada, Ontario | |
Credit Valley Eyecare | Recruiting |
Mississauga, Ontario, Canada, L5L 1W8 |
Study Director: | Fred Wassenburg | Sponsor GmbH |
Responsible Party: | Ophtec USA |
ClinicalTrials.gov Identifier: | NCT01547442 History of Changes |
Other Study ID Numbers: |
Artisan Pediatric Aphakia |
First Posted: | March 7, 2012 Key Record Dates |
Last Update Posted: | February 2, 2016 |
Last Verified: | January 2016 |
Keywords provided by Ophtec USA:
aphakia secondary intraocular lens congenital cataract marfan syndrome |
pediatric cataract ectopia lentis subluxated lens |
Additional relevant MeSH terms:
Aphakia Lens Diseases Eye Diseases |