Three Year Results from the United States FDA Prospective Multicenter Clinical Study of the EVO/EVO+ Implantable Collamer Lens
Bibliographic record
Abstract
Gregory Parkhurst,1 Jason P Brinton,2 Alan Faulkner,3 Majid Moshirfar,4 Lance J Kugler,5 Jason E Stahl,6 Zachary Zavodni,7 Vance M Thompson,8 Francis W Price,9 William F Wiley,10 Michael Aronsky,11 Jeffrey D Whitman,12 Jonathan D Solomon,13 Scott A Perkins,14 Mark Packer,15 Joanne Egamino16 1Department of Ophthalmology, Parkhurst NuVision, San Antonio, TX, USA; 2Department of Ophthalmology, Brinton Vision, St. Louis, MO, USA; 3Department of Ophthalmology, Aloha Laser Vision, Honolulu, HI, USA; 4Department of Ophthalmology, Hoopes Vision, Draper, UT, USA; 5Department of Ophthalmology, Kugler Vision, Omaha, NE, USA; 6Department of Ophthalmology, Durrie Vision, Overland Park, KS, USA; 7Department of Ophthalmology, The Eye Institute of Utah, Salt Lake City, UT, USA; 8Department of Ophthalmology, Vance Thompson Vision, Sioux Falls, SD, USA; 9Department of Ophthalmology, Price Vision Group, Indianapolis, IN, USA; 10Department of Ophthalmology, Kremer Eye Center, King of Prussia, PA, USA; 11MidWest Vision Eye Partners, Cleveland Eye Clinic, Brecksville, OH, USA; 12Department of Ophthalmology, Key-Whitman Eye Center, Dallas, TX, USA; 13Department of Ophthalmology, Solomon Eye Associates, Bowie, MD, USA; 14Department of Ophthalmology, Barnett Dulaney Perkins, Phoenix, AZ, USA; 15Packer Research Associates, Boulder, CO, USA; 16Clinical Affairs, STAAR Surgical, Lake Forest, CA, USACorrespondence: Joanne Egamino, VP of Global Clinical Affairs, STAAR Surgical Company, 25510 Commercentre, Lake Forest, CA, 92640, Tel +1 626-303-7902, Email jegamino@staar.comBackground: 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.Keywords: phakic refractive lens, myopia, astigmatism, implantable collamer lens, EVO ICL
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.015 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".