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Implantable Collamer Lens

Implantable Contact Lens for Near-sightedness

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 1-6 hours postoperatively
Awards & highlights

Study Summary

This trial will test the safety of a new type of contact lens that is implanted in the eye to improve vision.

Who is the study for?
This trial is for people with moderate to high near-sightedness and astigmatism, who have had stable vision for the past year. They must be able to attend follow-up visits and give written consent. It's not for those with glaucoma, previous eye surgery, severe diabetes, or women who are pregnant/nursing or planning pregnancy during the study.Check my eligibility
What is being tested?
The EVO ICL (Implantable Collamer Lens) is being tested in this study to see how it affects eye pressure after being implanted in patients with near-sightedness and astigmatism.See study design
What are the potential side effects?
Potential side effects may include an increase in eye pressure which can lead to discomfort or visual disturbances. Other risks typically associated with surgical procedures such as infection or inflammation might also occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-6 hours postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 hours postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Elevated Intraocular Pressure (IOP) in Primary Eyes
Secondary outcome measures
Elevated Intraocular Pressure (IOP) in Fellow Eyes

Trial Design

1Treatment groups
Experimental Treatment
Group I: EVO ICLExperimental Treatment1 Intervention
STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EVO ICL
2022
N/A
~210

Find a Location

Who is running the clinical trial?

Staar Surgical CompanyLead Sponsor
5 Previous Clinical Trials
722 Total Patients Enrolled
Joanne Egamino, PhDStudy DirectorStaar Surgical Company
4 Previous Clinical Trials
619 Total Patients Enrolled

Media Library

EVO ICL (Implantable Collamer Lens) Clinical Trial Eligibility Overview. Trial Name: NCT05538754 — N/A
Near-sightedness Research Study Groups: EVO ICL
Near-sightedness Clinical Trial 2023: EVO ICL Highlights & Side Effects. Trial Name: NCT05538754 — N/A
EVO ICL (Implantable Collamer Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538754 — N/A

Frequently Asked Questions

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

Is it possible to take part in this experiment?

"Eligible participants must meet two criteria: they should have myopia, and be between the ages of 21-45. Furthermore, this trial is aiming to enroll a total of 200 applicants."

Answered by AI

How many healthcare facilities in North America are currently engaged with this clinical experiment?

"Currently, 8 clinical sites are enrolling patients in this trial. These include Brecksville, Sioux Falls and Overland Park among other locales. To diminish travel constraints it is best to pick the nearest clinic if you decide to join the study."

Answered by AI

Are there any vacancies for participants in this research?

"As indicated on clinicaltrials.gov, this research project is presently recruiting volunteers; the initial posting was made on September 23rd 2022 and most recently updated on November 22nd 2022."

Answered by AI

Are seniors over 60 years old permitted to join this research venture?

"Qualified participants must meet the age criteria of this trial, which stipulates that they are 21 or older but no more than 45 years old."

Answered by AI

How many individuals are being included in this clinical investigation?

"To complete the study, Staar Surgical Company must enlist 200 suitable participants. Clinics in Brecksville, Ohio and Sioux Falls, South dakota are two of many locations providing patients with this opportunity."

Answered by AI

Who else is applying?

What site did they apply to?
Cleveland Eye Clinic
Aloha Laser Vision, LLC
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am interested in the affordable nature of such a procedure being performed for clinical research.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Post-Market Evaluation of the EVO ICL
2022. "Post-Market Evaluation of the EVO ICL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05538754.
All > Toronto > Honolulu
~79 spots leftby Apr 2025
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