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Phakic Intraocular Lens

Implantable Lens for Near-sightedness and Astigmatism

N/A
Waitlist Available
Research Sponsored by Staar Surgical Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing a new type of contact lens that is implanted in the eye to see if it is safe and effective for people with myopia or myopia with astigmatism.

Who is the study for?
This trial is for people with moderate to high nearsightedness or astigmatism, who have had a stable prescription for at least a year. Participants must be able to attend follow-up visits and provide informed consent. Pregnant women, those planning pregnancy, individuals with prior eye surgery, insulin-dependent diabetes, diabetic retinopathy or cataracts cannot join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of EVO/EVO+ Visian ICL lenses in correcting vision for myopia and myopic astigmatism. The main analysis happens after 300 eyes complete 6 months post-implantation; final analysis occurs when all treated eyes reach 36 months.See study design
What are the potential side effects?
While not specified here, typical side effects of implantable lenses can include discomfort or irritation in the eye, increased risk of cataracts, glaucoma due to raised pressure inside the eye, problems with night vision like halos around lights.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
Endothelial Cell Density (ECD) Change in Primary Eyes.
+2 more
Secondary outcome measures
Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.
Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.
Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Primary EyesExperimental Treatment1 Intervention
First implanted eyes of enrolled participants
Group II: Fellow EyesExperimental Treatment1 Intervention
Second implanted eyes of enrolled participants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EVO/EVO+ Visian ICL
2020
N/A
~330

Find a Location

Who is running the clinical trial?

Staar Surgical CompanyLead Sponsor
5 Previous Clinical Trials
600 Total Patients Enrolled
Joanne Egamino, PhDStudy DirectorVP, Global Clinical Affairs
4 Previous Clinical Trials
497 Total Patients Enrolled

Media Library

EVO/EVO+ Visian ICL (Phakic Intraocular Lens) Clinical Trial Eligibility Overview. Trial Name: NCT04283149 — N/A
Near-sightedness Research Study Groups: Fellow Eyes, Primary Eyes
Near-sightedness Clinical Trial 2023: EVO/EVO+ Visian ICL Highlights & Side Effects. Trial Name: NCT04283149 — N/A
EVO/EVO+ Visian ICL (Phakic Intraocular Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04283149 — N/A
Near-sightedness Patient Testimony for trial: Trial Name: NCT04283149 — N/A

Frequently Asked Questions

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

Who has access to the research opportunities presented by this experiment?

"This research seeks 327 people between the ages of 21 and 45 who have been diagnosed with myopia. To be eligible, patients must display moderate to high levels of myopic astigmatism that can be corrected via EVO/EVO+ ICL powers, have a stable refractive history within 0.50 D for one year prior to implantation, consent to post-surgery follow ups, and meet any additional criteria stipulated by this study's protocol."

Answered by AI

Does this trial extend to individuals who are 55 or older?

"This investigation requires participants to be between the ages of 21 and 45. There are 66 trials available for minors, while 42 studies exist for those older than 65 years old."

Answered by AI

Are there numerous facilities in Canada executing this clinical experiment?

"Patients for this medical study are being enrolled at the Barnett Dulaney Perkins clinic in Phoenix, Arizona; Kremer Eye Center of King Of Prussia, Pennsylvania; and Solomon Eye Physicians and Surgeons/Bowie Vision Institute located in Bowie, Maryland. Additionally there are 14 other sites participating as well."

Answered by AI

Are there any remaining openings to participate in this medical trial?

"According to clinicaltrials.gov, the study which was published on 30th January 2020 is not presently seeking participants, although there are 130 other trials currently recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
New York
Maryland
Texas
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Solomon Eye Physicians and Surgeons/Bowie Vision Institute
Vance Thompson Vision
Kremer Eye Center

What questions have other patients asked about this trial?

How long does this study take?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I was recently diagnosed with rapidly progressing cataracts and am near-sighted with significant astigmatism.
PatientReceived 2+ prior treatments
Contact lens options for my rx are very limited especially as of this winter and I would love to see if there are better options on the horizon for my eyesight.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)
2020. "Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04283149.
~63 spots leftby Apr 2025
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