Evidence map›Paper›PMID 40937096›Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2025

Three Year Results from the United States FDA Prospective Multicenter Clinical Study of the EVO/EVO+ Implantable Collamer Lens.

Gregory Parkhurst, Jason P Brinton, Alan Faulkner, Majid Moshirfar, Lance J Kugler, Jason E Stahl, Zachary Zavodni, Vance M Thompson, Francis W Price, William F Wiley and 6 more

Abstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Gregory ParkhurstDepartment of Ophthalmology, Parkhurst NuVision, San Antonio, TX, USA.
Jason P BrintonDepartment of Ophthalmology, Brinton Vision, St. Louis, MO, USA.
Alan FaulknerDepartment of Ophthalmology, Aloha Laser Vision, Honolulu, HI, USA.
Majid MoshirfarDepartment of Ophthalmology, Hoopes Vision, Draper, UT, USA.
Lance J KuglerDepartment of Ophthalmology, Kugler Vision, Omaha, NE, USA.
Jason E StahlDepartment of Ophthalmology, Durrie Vision, Overland Park, KS, USA.
Zachary ZavodniDepartment of Ophthalmology, The Eye Institute of Utah, Salt Lake City, UT, USA.
Vance M ThompsonDepartment of Ophthalmology, Vance Thompson Vision, Sioux Falls, SD, USA.
Francis W PriceDepartment of Ophthalmology, Price Vision Group, Indianapolis, IN, USA.
William F WileyDepartment of Ophthalmology, Kremer Eye Center, King of Prussia, PA, USA.
Michael AronskyMidWest Vision Eye Partners, Cleveland Eye Clinic, Brecksville, OH, USA.
Jeffrey D WhitmanDepartment of Ophthalmology, Key-Whitman Eye Center, Dallas, TX, USA.
Jonathan D SolomonDepartment of Ophthalmology, Solomon Eye Associates, Bowie, MD, USA.
Scott A PerkinsDepartment of Ophthalmology, Barnett Dulaney Perkins, Phoenix, AZ, USA.
Mark PackerPacker Research Associates, Boulder, CO, USA.ORCID 0000-0003-2681-6641
Joanne EgaminoClinical Affairs, STAAR Surgical, Lake Forest, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Continued safety and effectiveness of collamer EVO ICL posterior chamber phakic lenses with a central port design for the correction of myopia with or without astigmatism. Patients and Methods: Subjects aged 21 to 45 years with moderate to high myopia and astigmatism up to 4.00 D underwent EVO or EVO+ Sphere or Toric ICL (collectively referred to as EVO ICL) surgery. Uncorrected and corrected distance visual acuity (UDVA, CDVA), manifest refraction, intraocular pressure (IOP), endothelial cell density (ECD), and adverse events were assessed over 3 years. Results: This prospective multicenter study included 629 eyes (327 subjects), with a mean age of 35.6 ± 5.1 years. Mean spherical equivalent (SE) was -7.62 ± 2.75 D (range: -3.00 to -15.62 D) preoperatively, and -0.12 ± 0.30 D at 3 years with 90.7% of eyes within ± 0.50 D and 99.0% within ±1.00 D of target. Mean postoperative UDVA and CDVA were -0.053 ± 0.12 logMAR and -0.13 ± 0.08 logMAR, respectively. Additionally, 48.9% of eyes gained 1 or more lines of CDVA. Efficacy and safety indices were 1.07 and 1.25, respectively. Two eyes (0.32%) underwent lens exchange for high vault; neither of these demonstrated increased IOP. One eye (0.16%) developed an anterior subcapsular cataract (ASC) at 2 years. No eyes experienced pupillary block requiring peripheral iridotomy or iridectomy (PI), elevated IOP due to angle narrowing, or pigment dispersion. Mean ECD decreased by 3.0% from baseline at 1 year and by 6.7% at 3 years. Conclusion: This 3-year study confirmed the central port design of the EVO ICL functions effectively to allow physiologic flow of aqueous humor, thus eliminating the requirement for preoperative PI and reducing the incidence of ASC and pupillary block. EVO ICL lenses demonstrated accuracy and stability of refractive correction and achievement of high levels of UDVA.

Indexed as

astigmatismEVO ICLimplantable collamer lensmyopiaphakic refractive lens

Identifiers

PMID40937096
PMCPMC12420917

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.