EVO ICL Lenses* (EVO)

STAAR Surgical's phakic IOL for myopia with and without astigmatism

EVO Uses Advanced Technology to Provide Outstanding Safety and Effectiveness1,2

The novel 360 µm central port:

  • Eliminates the need for preoperative peripheral iridotomies (PIs)1
  • Lowers the risk of pupillary block and cataract1
  • Reduces office visits for the patient

An Exciting New Chapter in Refractive Surgery

Preserves the cornea and crystalline lens3
Does not induce dry eye syndrome4
Removable by a doctor
Rapid visual recovery3.5
No risk of ectasia5
No added complexity in future cataract surgery calculation6

Effectiveness

The effectiveness of EVO is demonstrated by the high levels of postoperative uncorrected visual acuity.1

Eyes (n)Follow up
Published Literature7n = 1,905Up to 5 years
FDA Clinical Trial1*n = 6296 months
Efficacy IndexUDVA
Published Literature71.04-0.02 logMAR
FDA Clinical Trial1*1.06-0.059 logMAR
Accuracy within ± 0.50 DAccuracy within ± 1.0 D
Published Literature790.8%98.7%
FDA Clinical Trial1*90.5%98.9%

*619 eyes (98.4%) were available for analysis at the 6-month visit.

Safety

Published safety data suggest reduced rates of anterior subcapsular cataract and pupillary block relative to earlier models.1

Eyes (n)Follow up
Published Literature7n = 4,196Up to 5 years
FDA Clinical Trial1*n = 6296 months
Safety IndexASC Cataract
Published Literature71.150.00% (n = 0)
FDA Clinical Trial1*1.240.00% (n = 0)
Pupillary BlockPigment Dispersion
Published Literature70.04% (n = 1)*0.00% (n = 0)
FDA Clinical Trial1*0.00% (n = 0)0.00% (n = 0)

*619 eyes (98.4%) were available for analysis at the 6-month visit.
**Due to retained viscoelastic.7 N=2,517

EVO uses an Exclusive, Premium Collamer® material

Collamer® is derived from two words that describe the composition of the material, which are “Collagen” and “Copolymer.”
Collamer® is a unique copolymer biocompatible material with properties that minimize inflammation, flare and cellular reaction.8,9
The Collamer® material is bonded with UV-absorbing chromophore into a poly-HEMA-based copolymer that offers UV protection.
Collamer® is exclusive to STAAR® Surgical. It has a proven history of over 30 years with more than 3 million ICLs distributed worldwide.

Will Levis
chose the EVO
procedure to help
him get rid of the
hassles of his
contacts & glasses

Outstanding postoperative uncorrected visual acuity1

Low rates of adverse events1

99.4% of patients surveyed would have the procedure again7

Let Your Patients Experience the Power of Visual Freedom

*The EVO family of lenses includes EVO ICL, EVO Toric ICL, EVO+ ICL and EVO+ Toric ICL

References

  1. Packer M. Evaluation of the EVO/EVO+ Sphere and Toric Visian ICL: Six month results from the United States Food and Drug Administration clinical trial. Clinical Ophthalmology. 2022;16:1541-53.
  2. Kamiya K, Shimizu K, Igarashi A, Kitazawa Y, Kojima T, Nakamura T, et al. Posterior chamber phakic intraocular lens implantation: comparative, multicentre study in 351 eyes with low-to-moderate or high myopia. Br J Ophthalmol. 2018;102(2):177-81.
  3. Kohnen T. Phakic intraocular lenses: Where are we now? J Cataract Refract Surg. 2018;44(2):121-3.
  4. Ganesh S, Brar S, Pawar A. Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction of low to moderate myopic astigmatism. Clin Ophthalmol. 2017;11:1253-63.
  5. Wei R, Li M, Zhang H, Aruma A, Miao H, Wang X, et al. Comparison of objective and subjective visual quality early after implantable collamer lens V4c (ICL V4c) and small incision lenticule extraction (SMILE) for high myopia correction. Acta Ophthalmol. 2020;98(8):e943-e50.
  6. Vargas V, Alió JL, Barraquer RI, JC DA, García C, Duch F, et al. Safety and visual outcomes following posterior chamber phakic intraocular lens bilensectomy. Eye Vis (Lond). 2020;7:34.
  7. Packer M. The Implantable Collamer Lens with a central port: review of the literature. Clin Ophthalmol. 2018;12:2427-38.
  8. Schild G, Amon M, Abela-Formanek C, Schauersberger J, Bartl G, Kruger A. Uveal and capsular biocompatibility of a single-piece, sharp-edged hydrophilic acrylic intraocular lens with collagen (Collamer): 1-year results. J Cataract Refract Surg. 2004;30(6):1254-8.
  9. Brown DC, Ziemba SL, Collamer IOL FDA Study Group. Collamer intraocular lens: clinical results from the US FDA core study. J Cataract Refract Surg. 2001 Jun;27(6):833-40.

Important Safety Information for the EVO ICL Product Family:

The EVO ICL is indicated for phakic patients 21-45 years of age to correct/reduce myopia with up to 4.00 D of astigmatism with a spherical equivalent ranging from -3.00 to -20.0 D and with an anterior chamber depth (ACD) 3.0 mm or greater.

The EVO ICL is contraindicated in patients with a true ACD of <3.00mm; with anterior chamber angle less than Grade III; who have moderate to severe glaucoma, who are pregnant or nursing; less than 21 years of age; and who do not meet the minimum endothelial cell density (ECD) listed in the Directions For Use (DFU).

A summary of the relevant warnings, precautions and side effects: Endothelial cell loss, corneal edema, cataract, narrowing of the anterior chamber angle, pupillary block, increased intraocular pressure, glaucoma, secondary surgery to reposition, replace or remove the ICL, loss of BSCVA, increase in refractive astigmatism, glare and/or halos, pigment dispersion, iris transillumination defects, endophthalmitis, hypopyon, corneal endothelial damage, ICL dislocation, cystoid macular edema, iritis, retinal detachment, vitritis, and iris prolapse.

Please review the DFU for complete safety and other information before performing the clinical procedure.

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