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CompletedNCT04283149Updated Mar 16, 2026Results posted

Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)

An interventional study of EVO/EVO+ Visian ICL in Myopia and Myopic Astigmatism, sponsored by Staar Surgical Company. Completed at 14 sites in United States. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Staar Surgical Company · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
327
Allocation
Non-randomized
Ages
21 Years to 45 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Myopia
  • Myopic Astigmatism

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Keywords

  • Nearsightedness
  • Phakic intraocular lens (IOL)
  • ICL
  • Toric ICL
  • EVO
  • EVO+
  • Visian
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 327 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Staar Surgical Company is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
327 participants (actual)

Study arms

  • Experimental
    Primary Eyes

    First implanted eyes of enrolled participants

    Device: EVO/EVO+ Visian ICL

  • Experimental
    Fellow Eyes

    Second implanted eyes of enrolled participants

    Device: EVO/EVO+ Visian ICL

Interventions

  • DeviceEVO/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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 Months

  2. 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.

    Time frame: 6 Months

  3. Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.

    Number of eyes with ECD \<1000 cells/mm² at month 6 in primary eyes.

    Time frame: 6 months

  4. Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.

    Number of eyes with ECD \<1500 cells/mm² at month 6 in primary eyes.

    Time frame: 6 months

  5. Number of Ocular Adverse Events (AEs) in Primary Eyes.

    Time frame: 6 Months

Secondary outcomes

  1. 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.

    Time frame: 6 Months

  2. 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.

    Time frame: 6 Months

  3. 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.

    Time frame: 6 months

  4. 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.

    Time frame: 6 months

  5. Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes

    Time frame: 6 Months

07

Results

Posted Jul 27, 2022

Participant flow

327 subjects were enrolled and treated at 14 clinical sites in the US. The first enrolled subject underwent surgery in the primary eye in January 2020 and the last eye was implanted in December 2020.

Participant flow — Overall Study
MilestonePrimary EyesFellow Eyes
Started327327
Postoperative month 6321321
Completed00
Not completed327327

Outcome measures

PrimaryNumber 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.

Time frame:
6 Months
Reported as:
Number · eyes
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)
eyesPrimary Eyes
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)0
PrimaryEndothelial 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.

Time frame:
6 Months
Reported as:
Mean · percentage change
Endothelial Cell Density (ECD) Change in Primary Eyes.
percentage changePrimary Eyes
Endothelial Cell Density (ECD) Change in Primary Eyes.-2.4 (-2.86 to -1.92)
PrimaryEndothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.

Number of eyes with ECD \<1000 cells/mm² at month 6 in primary eyes.

Time frame:
6 months
Reported as:
Number · eyes
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
eyesPrimary Eyes
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.0 (0.00 to 1.14)
PrimaryEndothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.

Number of eyes with ECD \<1500 cells/mm² at month 6 in primary eyes.

Time frame:
6 months
Reported as:
Number · eyes
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
eyesPrimary Eyes
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.0 (0.00 to 1.14)
PrimaryNumber of Ocular Adverse Events (AEs) in Primary Eyes.
Time frame:
6 Months
Reported as:
Number · events
Number of Ocular Adverse Events (AEs) in Primary Eyes.
eventsPrimary Eyes
Number of Ocular Adverse Events (AEs) in Primary Eyes.108
SecondaryNumber 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.

Time frame:
6 Months
Reported as:
Number · eyes
Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)
eyesPrimary and Fellow Eyes
Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)0
SecondaryEndothelial 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.

Time frame:
6 Months
Reported as:
Mean · percentage change
Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.
percentage changePrimary and Fellow Eyes
Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.-2.26 (-2.57 to -1.94)
SecondaryEndothelial 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.

Time frame:
6 months
Reported as:
Number · Eyes
Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.
EyesPrimary and Fellow Eyes
Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.0 (0.00 to 0.59)
SecondaryEndothelial 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.

Time frame:
6 months
Reported as:
Number · eyes
Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.
eyesPrimary and Fellow Eyes
Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.0 (0.00 to 0.59)
SecondaryNumber of Ocular Adverse Events (AEs) in Primary and Fellow Eyes
Time frame:
6 Months
Reported as:
Number · events
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes
eventsPrimary and Fellow Eyes
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes203

Adverse events

Collected over 6 months.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Primary Eyes0/327 (0%)10/327 (3.1%)82/327 (25.1%)
Fellow Eyes0/302 (0%)6/302 (2%)65/302 (21.5%)
Non-Ocular Serious Adverse Events0/327 (0%)2/327 (0.6%)—
Most frequent serious events
Most frequent serious events
EventPrimary EyesFellow EyesNon-Ocular Serious Adverse Events
Retinal detachmentEye disorders1/3272/3020/327
Retinal SurgeryEye disorders1/3272/3020/327
Narrow anterior chamber angleEye disorders2/3270/3020/327
Intraocular lens exchangeEye disorders2/3270/3020/327
Intraocular lens repositioningEye disorders2/3271/3020/327
Retinal tearEye disorders0/3271/3020/327
Glare/HaloEye disorders1/3270/3020/327
Intraocular lens removalEye disorders1/3270/3020/327
AmnesiaNervous system disorders0/3270/3021/327
Cerebral InfarctionVascular disorders0/3270/3021/327
Most frequent other events
Most frequent other events
EventPrimary EyesFellow EyesNon-Ocular Serious Adverse Events
Intraocular pressure increasedEye disorders75/32761/302—
Anterior chamber cell/flareEye disorders7/3274/302—

Baseline characteristics

Enrolled patients who underwent surgery with an investigational lens in at least one eye.

Age, Categorical
Age, Categorical(Participants)EVO ICL
<=18 years0
Between 18 and 65 years327
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)EVO ICL
Female213
Male114
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)EVO ICL
Hispanic or Latino34
Not Hispanic or Latino293
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)EVO ICL
American Indian or Alaska Native1
Asian38
Native Hawaiian or Other Pacific Islander3
Black or African American11
White274
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)EVO ICL
United States327
Preoperative Manifest Refraction Spherical Equivalent
Preoperative Manifest Refraction Spherical Equivalent(Diopters)EVO ICL
Primary Eyes-7.63 ± 2.80
Fellow Eyes-7.61 ± 2.72
08

Study locations

14 sites
  • Barnett Dulaney Perkins
    Phoenix, Arizona 85106, United States
  • Aloha Laser Vision, LLC
    Honolulu, Hawaii 96814, United States
  • Price Vision Group,
    Indianapolis, Indiana 46260, United States
  • Durrie Vision
    Overland Park, Kansas 66210, United States
  • Solomon Eye Physicians and Surgeons/Bowie Vision Institute
    Bowie, Maryland 20716, United States
  • Brinton Vision
    St Louis, Missouri 63141, United States
  • Kugler Vision, PC
    Omaha, Nebraska 68118, United States
  • Cleveland Eye Clinic
    Brecksville, Ohio 44141, United States
  • Kremer Eye Center
    King of Prussia, Pennsylvania 19406, United States
  • Vance Thompson Vision
    Sioux Falls, South Dakota 57108, United States
  • Key-Whitman Eye Center
    Dallas, Texas 75243, United States
  • Parkhurst NuVision
    San Antonio, Texas 78229, United States
  • Hoopes Vision/Hoopes, Durrie, Rivera Research
    Draper, Utah 84020, United States
  • The Eye Institute of Utah
    Salt Lake City, Utah 84107, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 30, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04283149
Lead sponsor
Staar Surgical Company
Responsible party
Sponsor
First posted
Feb 25, 2020
Start date
Jan 30, 2020
Primary completion
Apr 5, 2021
Completion
Dec 15, 2023
Results posted
Jul 27, 2022
Last update
Mar 16, 2026

Study contacts

Joanne Egamino, PhD
study director · VP, Global Clinical Affairs

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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