MyopiaNCT04283149
Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)
A study testing EVO/EVO+ Visian ICL in people with Myopia and Myopic Astigmatism, run by Staar Surgical Company at 14 sites in United States.
Trial summary
This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Myopia, Myopic Astigmatism
- What is being tested?
- EVO/EVO+ Visian ICL
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 14 sitesUnited States
- Study dates
- 30 Jan 2020to 15 Dec 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ ICL powers.
- 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.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Insulin-dependent diabetes or diabetic retinopathy.
- 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.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Solomon Eye Physicians and Surgeons/Bowie Vision Institute
Bowie, Maryland, 20716
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Key-Whitman Eye Center
Dallas, Texas, 75243
Hoopes Vision/Hoopes, Durrie, Rivera Research
Draper, Utah, 84020
Aloha Laser Vision, LLC
Honolulu, Hawaii, 96814
Price Vision Group,
Indianapolis, Indiana, 46260
Kremer Eye Center
King of Prussia, Pennsylvania, 19406
Kugler Vision, PC
Omaha, Nebraska, 68118
Durrie Vision
Overland Park, Kansas, 66210
Barnett Dulaney Perkins
Phoenix, Arizona, 85106
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Parkhurst NuVision
San Antonio, Texas, 78229
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Brinton Vision
St Louis, Missouri, 63141
About this study
Official title: A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens
This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.
Read the detailed description
This study will be conducted at up to 20 clinical sites in the United States by surgeons qualified by training and experience to implant STAAR ICLs.
- Conditions
- Myopia, Myopic Astigmatism
- Being tested
- EVO/EVO+ Visian ICL
- Keywords
- Nearsightedness, Phakic intraocular lens (IOL), ICL, Toric ICL, EVO, EVO+, Visian
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO/EVO+ Visian ICLDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary Eyes | Experimental | First implanted eyes of enrolled participants Receives: Device: EVO/EVO+ Visian ICL |
| Fellow Eyes | Experimental | Second implanted eyes of enrolled participants Receives: Device: EVO/EVO+ Visian ICL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)
Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.
Measured: 6 Months
Endothelial Cell Density (ECD) Change in Primary Eyes.
Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes. Negative outcome values represent a reduction in Endothelial Cell Density.
Measured: 6 Months
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
Number of eyes with ECD <1000 cells/mm² at month 6 in primary eyes.
Measured: 6 months
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
Number of eyes with ECD <1500 cells/mm² at month 6 in primary eyes.
Measured: 6 months
Number of Ocular Adverse Events (AEs) in Primary Eyes.
Measured: 6 Months
Secondary outcomes (5)
Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)
Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes.
Measured: 6 Months
Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.
Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes and fellow eyes. Negative outcome values represent a reduction in Endothelial Cell Density.
Measured: 6 Months
Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.
Number of eyes with ECD <1000 cell/mm² at month 6 in primary and fellow eyes.
Measured: 6 months
Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.
Number of eyes with ECD <1500 cell/mm² at month 6 in primary and fellow eyes.
Measured: 6 months
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start30 Jan 2020
- Primary completion5 Apr 2021
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All enrolled eyes will undergo phakic eye surgery to have one of the available implantable collamer lenses EVO or EVO+ (spherical or toric) ICL implanted in their primary eye. Fellow eye surgery will occur between 7 and 14 days after primary eye surgery.
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staar Surgical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Egamino, PhD, Study director, VP, Global Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283149
- Sponsor's protocol ID
- CP19-01
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2020
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No