NCT05538754 is a NA clinical trial of EVO ICL in Myopia, sponsored by Staar Surgical Company.

Who is sponsoring NCT05538754?

NCT05538754 is sponsored by Staar Surgical Company.

What drugs are being tested in NCT05538754?

Interventions in NCT05538754: EVO ICL.

What condition does NCT05538754 study?

NCT05538754 studies Myopia, Myopic Astigmatism.

Is NCT05538754 still recruiting?

NCT05538754 is currently completed. Last updated 5 March 2026.

Are results published for NCT05538754?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-03-05 · How we verify

NCT05538754

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Post-Market Evaluation of the EVO ICL

Completed NA Results posted Last updated 5 March 2026

What this trial tests

NA trial testing EVO ICL in Myopia in 205 participants. Completed in 4 October 2023.

Timeline

23 September 2022

Primary endpoint
21 September 2023

4 October 2023

Quick facts

Lead sponsor	Staar Surgical Company
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	205
Start date	23 September 2022
Primary completion	21 September 2023
Estimated completion	4 October 2023
Sites	8 locations across United States

Drugs / interventions tested

EVO ICL

Conditions studied

Myopia — all drugs for Myopia →
Myopic Astigmatism — all drugs for Myopic Astigmatism →

Sponsor

Staar Surgical Company — full company profile →

Who can join

Adults 21 to 45, any sex, with Myopia or Myopic Astigmatism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg Primary · 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.

Group	Value	95% CI
Primary Eyes	15

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

Group	Value	95% CI
Primary Eyes	4

Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg Secondary · 1-6 hours postoperatively

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.

Group	Value	95% CI
Fellow Eyes	16

Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG Secondary · 1-6 hours postoperatively

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.

Group	Value	95% CI
Fellow Eyes	6

Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD Secondary · 1-6 hours postoperatively

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.

Group	Value	95% CI
All Treated Eyes	42

Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes Secondary · 1-6 hours postoperatively

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

Group	Value	95% CI
All Treated Eyes	0

Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD Secondary · Day 1 postoperatively

Group	Value	95% CI
All Treated Eyes	43

Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes Secondary · Day 1 postoperatively

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

Group	Value	95% CI
All Treated Eyes	0

Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD Secondary · Day 5-9 postoperatively

Group	Value	95% CI
All Treated Eyes	43

Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes Secondary · Day 5-9 postoperatively

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

Group	Value	95% CI
All Treated Eyes	1

Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD Secondary · Day 10-18 postoperatively

Group	Value	95% CI
All Treated Eyes	43

Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes Secondary · Day 10-18 postoperatively

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

Group	Value	95% CI
All Treated Eyes	6

Adverse events — posted to ClinicalTrials.gov

Time frame: Collection of adverse events began at the time of informed consent and continued until study completion (approximately 2-3 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Treated Eyes

Serious: 2/408 (0%)

Deaths: 0/205

Serious adverse events (4 terms)

Reaction	System	All Treated Eyes
Incorrect EVO ICL Implantation	Eye disorders	—
Intraocular Lens Exchange	Eye disorders	—
Intraocular Cilium	Eye disorders	—
Surgery to Remove Intraocular Cilium	Eye disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	All Treated Eyes
Intraocular Pressure Increased	Eye disorders	—

Most-reported serious reactions: Incorrect EVO ICL Implantation, Intraocular Lens Exchange, Intraocular Cilium, Surgery to Remove Intraocular Cilium.

Data from ClinicalTrials.gov NCT05538754 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Human retinal secretome: A cross-link between mesenchymal and retinal cells.
Donato L, Scimone C, Alibrandi S, Scalinci SZ, et al · · 2023 · cited 6× · PMID 37545752 · DOI 10.4252/wjsc.v15.i7.665

Verify or expand the search:

Other recruiting trials for Myopia

Currently open trials in the same condition.

NCT07284966 — Comfort and Vision With TOTAL30 Multifocal Lenses · recruiting
NCT07078799 — Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery · NA · recruiting
NCT07585877 — Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression · NA · active not recruiting
NCT07354945 — An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children · NA · recruiting
NCT07229365 — Children's Viewing Behavior · NA · recruiting

Other Staar Surgical Company trials

Trials by the same sponsor.

NCT07291739 — A Clinical Evaluation of a Phakic Intraocular Lens · NA · completed
NCT04516772 — STAAR Visian Toric ICL Post-Approval Study · NA · completed
NCT04283149 — Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL) · NA · completed
NCT03499821 — Clinical Performance of a Phakic Intraocular Lens (IOL) · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05538754 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Staar Surgical Company
Last refreshed: 5 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05538754.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05538754

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Myopia

Other Staar Surgical Company trials

Verify against primary sources