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Artisan Aphakia Lens for Childhood Aphakia
Study Summary
This trial will test the safety and effectiveness of a new lens to treat aphakia (a condition where the eye's natural lens is missing) in children.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have an eye condition affecting my iris or eye structure.I have an eye condition that affects the macula.I have glaucoma that is not well-managed.I have ongoing or recurring inflammation in my eye.I am between 2 and 21 years old.My eye's lens capsule is damaged, preventing standard lens implant.I am blind or almost blind in my other eye.I have had a retinal detachment or it runs in my family.I have an eye condition that could affect my vision.I have diabetes.I am under 2 years old.My legal representative can sign the consent form for me.I have had a corneal disease in the past.I have an eye condition affecting my optic nerve and vision.I need surgery for a significant cataract or to replace my lens.Patients with intellectual disabilities.
- Group 1: Artisan Aphakia Intraocular Lens
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many medical institutions are running this clinical trial?
"Currently, this study is recruiting at 16 different locations, which include the Mayo Clinic in Rochester, the Medical University of South carolina, the Storm Eye Institute in Charleston, Washington University, and St. Louis Children's Hospital in Saint Louis, among others."
Has the Artisan Aphakia Intraocular Lens device been cleared by the FDA?
"There is some clinical data to support the efficacy of Artisan Aphakia Intraocular Lens, as well as multiple rounds of data indicating its safety. Consequently, our team at Power rates the safety of this product as a 3."
Who does this clinical trial open to?
"To qualify for this clinical trial, participants must have aphakia and be between the ages of 2 and 21. A total of 300 candidates are needed for the study."
What is the largest amount of people who are allowed to participate in this experiment?
"Yes, that is correct. The trial, which was first posted on January 1st, 2012, is still recruiting patients. The 300 patients will be drawn from 16 different medical sites."
Would patients who are older than 30 be able to join this clinical trial?
"The target recruitment pool for this clinical trial are children who are over the age of two, but younger than 21."
Are people actively being recruited for this experiment?
"Yes, according to the information on clinicaltrials.gov, this trial is currently recruiting patients. The study was first posted on January 1, 2012, and was last updated on June 24, 2022. The trial is looking for 300 participants across 16 locations."
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