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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
Have a visually significant cataract or need IOL replacement surgery
Compromised capsular bag prohibiting implantation of standard posterior IOL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years follow up
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.

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 need surgery for a significant cataract or to replace my lens.
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My eye's lens capsule is damaged, preventing standard lens implant.
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My legal representative can sign the consent form for me.
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I am between 2 and 21 years old.

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

Awards & Highlights

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.

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~38 spots leftby Dec 2025