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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 year follow up
Awards & highlights
Study Summary
This trial will test a new lens to see if it's safe and effective in correcting aphakia (lack of a natural lens) in adults.
Who is the study for?
Adults over the age of 22 who have had their natural lens removed and cannot have a standard lens implant. Participants must be able to attend all study visits and comply with requirements. Excluded are those with certain eye diseases, uncontrolled glaucoma, diabetes, pregnant or lactating women, or those unable to undergo postoperative evaluations.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of the Artisan Aphakia Lens as a secondary option for adults lacking natural lenses in their eyes. The focus is on whether this lens can effectively correct vision when standard implants aren't suitable.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include inflammation, increased eye pressure, infection risk after surgery, potential impact on vision clarity or field of vision due to complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 22 and need or have had my natural lens removed without needing a specific type of lens implant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 year follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 year follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in best corrected visual acuity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intraocular Lens Implantation for the Treatment for AphakiaExperimental Treatment1 Intervention
Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes.I am over 22 and need or have had my natural lens removed without needing a specific type of lens implant.I have an eye condition that affects my iris and could interfere with eye procedures.I have glaucoma that is not well-managed.I have a history of eye diseases that could affect my vision.I have an eye condition that could affect lens assessment.I have had uveitis in the past or it keeps coming back.I have or someone in my family has had a detached retina.I have a condition affecting my optic nerve that could limit my vision.I have a retinal condition that could affect my vision, like retinopathy of prematurity or Stargardt's.
Research Study Groups:
This trial has the following groups:- Group 1: Intraocular Lens Implantation for the Treatment for Aphakia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently open for this clinical research trial?
"According to clinicaltrials.gov, this medical study is actively on the lookout for participants. The trial was initially posted on January 1st 2012 and underwent its most recent edit on June 24th 2022."
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