Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2012 |
End Date: | December 2021 |
Contact: | Fred Wassenburg |
Email: | f.wassenburg@ophtec.com |
Phone: | 561-989-8767 |
Artisan Aphakia Lens for the Correction of Aphakia in Adults
This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used
as a secondary implant to correct aphakia in adults.
as a secondary implant to correct aphakia in adults.
Not desired
Inclusion Criteria:
- Patients 22 years of age and over at baseline visit of either sex and of any race
where the natural lens has been removed or will be removed and a posterior chamber
IOL is not indicated.
- Patient must agree to comply with the visit schedule and other requirements of the
study
Exclusion Criteria:
- Patients that are not able to meet the extensive postoperative evaluation
requirements
- Mentally retarded patients
- When the patient has no useful vision or vision potential in the fellow eye
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.),
corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
- Abnormality of the iris or ocular structure which would preclude fixation, such as
aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising
iris pathology
- Patients with uncontrolled glaucoma
- High preoperative intraocular pressure, >25 mmHg
- Chronic or recurrent uveitis or history of the same
- Preexisting macular pathology that may complicate the ability to assess the benefit
or lack of benefit obtained by the lens
- Patients with a retinal detachment or a family history of retinal detachment
- Retinal disease that may limit the visual potential of the eye such as retinopathy of
prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual
potential of the eye
- Diabetes mellitus
- Pregnant, lactating, or plans to become pregnant during the course of this study
We found this trial at
12
sites
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