MyopiaNCT05538754

Post-Market Evaluation of the EVO ICL

A study testing EVO ICL in people with Myopia and Myopic Astigmatism, run by Staar Surgical Company at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 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 ICL
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 205 participants
Where: 8 sitesUnited States
Study dates: 23 Sep 2022to 4 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 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.

Who cannot join

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Cleveland Eye Clinic
Brecksville, Ohio, 44141
Key-Whitman Eye Center
Dallas, Texas, 75243
Aloha Laser Vision, LLC
Honolulu, Hawaii, 96814
Kugler Vision, PC
Omaha, Nebraska, 68118
Durrie Vision
Overland Park, Kansas, 66210
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Parkhurst NuVision
San Antonio, Texas, 78229
Vance Thompson Vision
Sioux Falls, South Dakota, 57108

Other trials in United States

About this study

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.

Conditions: Myopia, Myopic Astigmatism
Being tested: EVO ICL
Keywords: nearsightedness, phakic IOL, toric ICL, ICL, TICL, EVO, astigmatism
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 ICLDevice
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.

Study groups in NCT05538754
Study group	Role	What they receive
EVO ICL	Other	STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism. Receives: Device: EVO ICL

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1-6 hours postoperatively
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.
Measured: 1-6 hours postoperatively

Secondary outcomes (2)

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.
Measured: 1-6 hours postoperatively
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.
Measured: 1-6 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 20224 Oct 2023

First posted14 Sep 2022
Study start23 Sep 2022
Primary completion21 Sep 2023
Study completion4 Oct 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: Not applicable
Intervention model: Single group
Model description: All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.
Masking: None (open label)
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05538754
Sponsor's protocol ID: CP22-01
Status last verified: Mar 2026
First submitted: 9 Sep 2022
Last updated: 5 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Market Evaluation of the EVO ICL
ClinicalTrials.gov ID: NCT05538754
Acronym / sponsor ID: CP22-01
Conditions: Myopia, Myopic Astigmatism
Keywords: nearsightedness, phakic IOL, toric ICL, ICL, TICL, EVO, astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: Staar Surgical CompanyIndustry (pharma, biotech, devices)
Study start: 23 Sep 2022 (actual)
Primary completion: 21 Sep 2023 (actual)
Study completion: 4 Oct 2023 (actual)
First posted: 14 Sep 2022 (actual)
Results: Posted 3 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.

Arm	Type	Receives
EVO ICL	Other	Device: EVO ICLSTAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.

Who may qualify

Ages: 21 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EVO ICLThe 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.	Device	EVO ICL

Primary outcome

Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg
Time frame: 1-6 hours postoperatively
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.
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG
Time frame: 1-6 hours postoperatively
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.

2 secondary outcomes

Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg
Time frame: 1-6 hours postoperatively
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG
Time frame: 1-6 hours postoperatively

Results and safety

Results posted to the registry on 3 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Eyes	205	205
Fellow Eyes	205	205

Primary outcome: Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg

Time frame: 1-6 hours postoperatively. Count of units. Unit: Eyes

Measure	Primary Eyes n = 205
Value	15

Primary outcome: Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG

Time frame: 1-6 hours postoperatively. Count of units. Unit: Eyes

Measure	Primary Eyes n = 205
Value	4

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collection of adverse events began at the time of informed consent and continued until study completion (approximately 2-3 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Treated Eyes	2 of 408 (0.5%)	45 of 408 (11%)	0 of 205

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
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Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joanne Egamino, PhD study director

Staar Surgical Company

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EVO ICL in people with Myopia and Myopic Astigmatism, run by Staar Surgical Company at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg (time frame: 1-6 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05538754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.