Artisan Aphakia Lens for the Correction of Aphakia in Children

Study on the Safety and Effectiveness of an Investigational Intraocular Lens for Aphakia

Recruiting
2 years - 21 years
All
Phase N/A
1 Location

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.

Participants will not be paid for their participation.

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

Updated on 19 Feb 2024. Study ID: 1209009465

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.

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