Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)
NCT ID: NCT04283149
Last Updated: 2025-03-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
327 participants
INTERVENTIONAL
2020-01-30
2023-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Evaluation of a Phakic Intraocular Lens
NCT07291739
Post-Market Evaluation of the EVO ICL
NCT05538754
A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses
NCT06839898
STAAR Visian Toric ICL Post-Approval Study
NCT04516772
Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
NCT03059043
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Primary Eyes
First implanted eyes of enrolled participants
EVO/EVO+ Visian ICL
The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Fellow Eyes
Second implanted eyes of enrolled participants
EVO/EVO+ Visian ICL
The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EVO/EVO+ Visian ICL
The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
* Able and willing to return for scheduled follow-up examinations after surgery.
* Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
Exclusion Criteria
* History of previous ocular surgery.
* Cataract of any grade.
* Monocular.
* Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
21 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Staar Surgical Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joanne Egamino, PhD
Role: STUDY_DIRECTOR
VP, Global Clinical Affairs
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barnett Dulaney Perkins
Phoenix, Arizona, United States
Aloha Laser Vision, LLC
Honolulu, Hawaii, United States
Price Vision Group,
Indianapolis, Indiana, United States
Durrie Vision
Overland Park, Kansas, United States
Solomon Eye Physicians and Surgeons/Bowie Vision Institute
Bowie, Maryland, United States
Brinton Vision
St Louis, Missouri, United States
Kugler Vision, PC
Omaha, Nebraska, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Kremer Eye Center
King of Prussia, Pennsylvania, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Parkhurst NuVision
San Antonio, Texas, United States
Hoopes Vision/Hoopes, Durrie, Rivera Research
Draper, Utah, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP19-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.