Artisan Aphakia Lens for the Correction of Aphakia in Children
Study on the Safety and Effectiveness of an Investigational Intraocular Lens for Aphakia
Brief description of study.
The purpose of this study is to evaluate the safety and effectiveness of an intraocular (IOL) lens called the ARTISAN? Aphakia Lens for the correction of aphakia.
Detailed description of study
The purpose of this study is to evaluate the safety and effectiveness of an intraocular (IOL) lens called the ARTISAN? Aphakia Lens for the correction of aphakia.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Aphakia
-
Age: 2 years - 21 years
-
Gender: All
Inclusion Criteria
Diagnosed with aphakia or a significant cataract
Exclusion Criteria
History of corneal disease
Diagnosed with uncontrolled glaucoma
Diagnosed with diabetes
Currently pregnant or breast feeding
This study investigates the safety and effectiveness of an investigational intraocular lens for people with aphakia. Aphakia is a condition where the eye's natural lens is absent, often due to surgery or injury. The study aims to understand how well the lens works and how safe it is for patients with this condition.
Participants will undergo procedures related to the placement and monitoring of the investigational lens. This includes regular eye examinations and assessments to ensure the lens is functioning as intended and to monitor for any potential side effects.
- Who can participate: Adults diagnosed with aphakia or a significant cataract may participate. Individuals with a history of corneal disease, uncontrolled glaucoma, diabetes, or those who are currently pregnant or breastfeeding are not eligible.
- Study details: Participants will have an investigational intraocular lens placed in their eye. They will attend follow-up visits for regular eye examinations to assess the lens's effectiveness and safety.