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Intraocular Lens

Artisan Aphakia Lens for Childhood Aphakia

Phase 3
Recruiting
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

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.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best corrected distance visual acuity at 12 months postoperative

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

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.

Find a Location

Who is running the clinical trial?

Ophtec USALead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Aphakia
300 Patients Enrolled for Aphakia
Fred WassenburgStudy DirectorSponsor GmbH
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Aphakia
300 Patients Enrolled for Aphakia
Abraham FarhanStudy DirectorSponsor GmbH
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Aphakia
300 Patients Enrolled for Aphakia

Media Library

Artisan Aphakia Lens (Intraocular Lens) Clinical Trial Eligibility Overview. Trial Name: NCT01547442 — Phase 3
Aphakia Research Study Groups: Artisan Aphakia Intraocular Lens
Aphakia Clinical Trial 2023: Artisan Aphakia Lens Highlights & Side Effects. Trial Name: NCT01547442 — Phase 3
Artisan Aphakia Lens (Intraocular Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01547442 — Phase 3
~29 spots leftby Dec 2025
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