What is the mechanism of action of this treatment?

Aphakia is the absence of the lens in the eye, often treated by implanting an intraocular lens (IOL) like the Artisan Aphakia Lens. This lens replaces the missing natural lens, restoring the eye's ability to focus light onto the retina. The IOL takes over the refractive function, crucial for clear vision, significantly improving visual acuity and quality of life for aphakia patients by reducing dependence on thick corrective lenses or contact lenses.

What side effects are associated with this type of intervention?

The most common treatments for aphakia, such as intraocular lens (IOL) replacement including the Artisan Aphakia Lens, can have side effects like infection, inflammation, increased intraocular pressure, and potential dislocation or malposition of the lens. Patients may also experience visual disturbances such as glare, halos, or double vision. These risks highlight the importance of careful monitoring and follow-up with an ophthalmologist post-surgery.

What prior FDA approvals exist?

The FDA has approved several intraocular lenses (IOLs) for the treatment of aphakia, a condition where the eye's natural lens is absent. Notable examples include the Crystalens AT-45, which is designed to provide uncorrected distance, intermediate, and near visual acuities in patients undergoing cataract extraction. These IOLs are implanted to replace the missing natural lens, thereby restoring vision. The Artisan Aphakia Lens, currently under study, is another IOL aimed at treating aphakia, particularly in children, by providing a safe and effective lens replacement option.

What other types of research exist?

Promising alternatives to the Artisan Aphakia Lens for aphakia patients in 2024 include: 1) Phakic intraocular lenses (IOLs) such as the EVO/EVO+ Visian ICL, which have shown improved visual performance and safety profiles. 2) Multifocal and extended depth of focus (EDOF) IOLs, which provide better visual outcomes across various distances. 3) The use of femtosecond laser-assisted cataract surgery (FLACS) for more precise and safer IOL implantation. These alternatives offer advancements in visual acuity, patient satisfaction, and reduced complication rates.

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Intraocular Lens

Artisan Aphakia Lens for Childhood Aphakia

N/A

Waitlist Available

Research Sponsored by Ophtec USA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

2 to 21 years of age

Compromised capsular bag prohibiting implantation of standard posterior IOL

Must not have

Chronic or recurrent uveitis

No useful vision or vision potential in fellow eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special eye implant called the Artisan Aphakia Lens to help children who have lost their natural lens see clearly again. The study aims to find out if this lens is safe and effective for these children.

Who is the study for?

This trial is for children and young adults aged 2 to 21 with aphakia, which means they're missing their natural eye lens. They should need an intraocular lens (IOL) because of a cataract or replacement surgery but can't have a standard IOL due to issues with the capsular bag. Participants must be able to follow the study schedule and requirements.

What is being tested?

The Artisan Aphakia Intraocular Lens is being tested for safety and effectiveness in treating aphakia in children. This study will involve implanting this special lens into participants' eyes who cannot receive standard posterior IOL implants.

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort, inflammation, increased eye pressure, infection risk post-surgery, vision changes like blurriness or glare, and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 2 and 21 years old.

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My eye's lens capsule is damaged, preventing standard lens implant.

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I need surgery for a significant cataract or to replace my lens.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have ongoing or recurring inflammation in my eye.

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I am blind or almost blind in my other eye.

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I have an eye condition affecting my iris or eye structure.

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I have glaucoma that is not well-managed.

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I have had a retinal detachment or it runs in my family.

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I have an eye condition that could affect my vision.

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I have diabetes.

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I am under 2 years old.

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I have had a corneal disease in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best corrected distance visual acuity at 12 months postoperative

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Artisan Aphakia Intraocular LensExperimental Treatment1 Intervention

Implantation of an Artisan intraocular lens to correct aphakia in children

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Aphakia is the absence of the lens in the eye, often treated by implanting an intraocular lens (IOL) like the Artisan Aphakia Lens. This lens replaces the missing natural lens, restoring the eye's ability to focus light onto the retina. The IOL takes over the refractive function, crucial for clear vision, significantly improving visual acuity and quality of life for aphakia patients by reducing dependence on thick corrective lenses or contact lenses.