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CompletedNCT05538754Updated Mar 5, 2026Results posted

Post-Market Evaluation of the EVO ICL

An interventional study of EVO ICL in Myopia and Myopic Astigmatism, sponsored by Staar Surgical Company. Completed at 8 sites in United States. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

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

Phase
Not applicable
Study type
Interventional
Enrollment
205
Allocation
Not applicable
Ages
21 Years to 45 Years
Sex
All
01

Study summary

The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).

Read the detailed description

This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.

02

Conditions studied

  • Myopia
  • Myopic Astigmatism

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Keywords

  • nearsightedness
  • phakic IOL
  • toric ICL
  • ICL
  • TICL
  • EVO
  • astigmatism
03

In context

Myopia

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

This study's enrollment of 205 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 correctable with available EVO ICL powers.
  • Moderate to high myopic with astigmatism correctable with available EVO ICL powers.
  • Stable refractive history within 0.50 D cylinder for 1 year prior to implantation.
  • Stable refractive history within 0.50 D for spherical equivalent 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:

  • Ocular hypertension or glaucoma.
  • Insulin dependent diabetes or diabetic retinopathy.
  • History of previous ocular surgery.
  • Monocular.
  • Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
  • Other protocol-specified exclusion criteria may apply.
05

Study design

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

Study arms

  • Other
    EVO ICL

    STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.

    Device: EVO ICL

Interventions

  • DeviceEVO ICL

    The EVO ICL is 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. Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg

    The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

    Time frame: 1-6 hours postoperatively

  2. Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG

    The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

    Time frame: 1-6 hours postoperatively

Secondary outcomes

  1. Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg

    The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

    Time frame: 1-6 hours postoperatively

  2. Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG

    The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

    Time frame: 1-6 hours postoperatively

Other outcomes

  1. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

    Time frame: 1-6 hours postoperatively

  2. Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

    Time frame: 1-6 hours postoperatively

  3. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

    Time frame: Day 1 postoperatively

  4. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

    Time frame: Day 1 postoperatively

  5. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

    Time frame: Day 5-9 postoperatively

  6. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

    Time frame: Day 5-9 postoperatively

  7. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

    Time frame: Day 10-18 postoperatively

  8. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes

    Time frame: Day 10-18 postoperatively

07

Results

Posted Dec 3, 2024

Participant flow

205 subjects were enrolled and treated at 8 clinical sites in the United States. The first enrolled subject underwent surgery in the primary eye on 05 Oct 2022 and the last eye was implanted on 21 Sep 2023.

Participant flow — Overall Study
MilestonePrimary EyesFellow Eyes
Started205205
Completed205205
Not completed00

Outcome measures

PrimaryElevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg

The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Time frame:
1-6 hours postoperatively
Reported as:
Count of units · Eyes
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg
EyesPrimary Eyes
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg15
PrimaryElevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG

The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Time frame:
1-6 hours postoperatively
Reported as:
Count of units · Eyes
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG
EyesPrimary Eyes
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG4
SecondaryElevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg

The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Time frame:
1-6 hours postoperatively
Reported as:
Count of units · Eyes
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg
EyesFellow Eyes
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg16
SecondaryElevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG

The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Time frame:
1-6 hours postoperatively
Reported as:
Count of units · Eyes
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG
EyesFellow Eyes
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG6
Other pre-specifiedCumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

Time frame:
1-6 hours postoperatively
Reported as:
Count of units · Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
EyesAll Treated Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD42
Other pre-specifiedCumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

Time frame:
1-6 hours postoperatively
Reported as:
Count of units · Eyes
Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
EyesAll Treated Eyes
Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes0
Other pre-specifiedCumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

Time frame:
Day 1 postoperatively
Reported as:
Count of units · Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
EyesAll Treated Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD43
Other pre-specifiedCumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

Time frame:
Day 1 postoperatively
Reported as:
Count of units · Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
EyesAll Treated Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes0
Other pre-specifiedCumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

Time frame:
Day 5-9 postoperatively
Reported as:
Count of units · Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
EyesAll Treated Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD43
Other pre-specifiedCumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

Time frame:
Day 5-9 postoperatively
Reported as:
Count of units · Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
EyesAll Treated Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes1
Other pre-specifiedCumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

Time frame:
Day 10-18 postoperatively
Reported as:
Count of units · Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
EyesAll Treated Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD43
Other pre-specifiedCumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes

Time frame:
Day 10-18 postoperatively
Reported as:
Count of units · Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
EyesAll Treated Eyes
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes6

Adverse events

Collected over Collection of adverse events began at the time of informed consent and continued until study completion (approximately 2-3 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Treated Eyes0/205 (0%)2/408 (0.5%)45/408 (11%)
Most frequent serious events
Most frequent serious events
EventAll Treated Eyes
Incorrect EVO ICL ImplantationEye disorders1/408
Intraocular Lens ExchangeEye disorders1/408
Intraocular CiliumEye disorders1/408
Surgery to Remove Intraocular CiliumEye disorders1/408
Most frequent other events
Most frequent other events
EventAll Treated Eyes
Intraocular Pressure IncreasedEye disorders45/408

Baseline characteristics

Baseline data were collected on the whole participant level

Age, Categorical
Age, Categorical(Participants)EVO ICL
<=18 years0
Between 18 and 65 years205
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)EVO ICL
Female126
Male79
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)EVO ICL
Hispanic or Latino33
Not Hispanic or Latino172
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)EVO ICL
American Indian or Alaska Native2
Asian24
Native Hawaiian or Other Pacific Islander0
Black or African American1
White176
More than one race2
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)EVO ICL
United States205
08

Study locations

8 sites
  • Aloha Laser Vision, LLC
    Honolulu, Hawaii 96814, United States
  • Durrie Vision
    Overland Park, Kansas 66210, United States
  • Kugler Vision, PC
    Omaha, Nebraska 68118, United States
  • Cleveland Eye Clinic
    Brecksville, Ohio 44141, 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
  • The Eye Institute of Utah
    Salt Lake City, Utah 84107, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 25, 2023

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 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05538754
Lead sponsor
Staar Surgical Company
Responsible party
Sponsor
First posted
Sep 14, 2022
Start date
Sep 23, 2022
Primary completion
Sep 21, 2023
Completion
Oct 4, 2023
Results posted
Dec 3, 2024
Last update
Mar 5, 2026

Study contacts

Joanne Egamino, PhD
study director · Staar Surgical Company

Oversight

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

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