Artisan Aphakia Lens for the Correction of Aphakia in Children
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 2 - 21 |
Updated: | 4/21/2016 |
Start Date: | January 2012 |
End Date: | December 2021 |
Contact: | Fred Wassenburg |
Email: | f.wassenburg@ophtec.com |
Phone: | 561-989-8767 |
The purpose of this study is to determine the safety and effectiveness of the Artisan
Aphakia Lens in the treatment of aphakia in children.
Aphakia Lens in the treatment of aphakia in children.
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
We found this trial at
16
sites
Pittsburgh, Pennsylvania 15224
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Mayfield Heights, Ohio 44124
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