STAAR EVO ICL obtains FDA approval

Editor’s Note: The opinions expressed in this blog are those of their respective contributors and do not represent the opinions of Ophthalmology time® or MJH Life Sciences®

There is a new alternative to LASIK in the United States: an alternative that preserves the cornea and the lens¹that does not aggravate the dry eye²increase the risk of ectasia³ or complicate IOL power calculations for future cataract surgery⁴; an alternative that allows rapid visual recovery and is reversible.¹

This alternative is the EVO ICL.

On March 25, 2022, the FDA approved STAAR Surgical’s EVO/EVO+ VISIAN implantable collamer lens (ICL) and toric implantable collamer lens (TICL)⁵.

Refractive surgeons in the United States already knew the indications for these lenses, as they are the same as the MICL, approved in 2005, and the TICL, approved in 2018. The breakthrough is the innovative 360 ​​micron center port of diameter. in the EVO/EVO+ sphere and ICL toric lenses which facilitates the physiological flow of aqueous humor, eliminating the need for peripheral iridotomies before implantation.

Outside the United States, EVO lenses have been commercially available since 2011 and EVO+ lenses since 2016. EVO and EVO+ lenses are available in over 75 countries (EVO+ features a larger optical size and is otherwise similar) . Where these lens designs are available, including now in the United States, patients need fewer office visits and procedures before starting a new life without relying on contacts or glasses.

Eliminating the need for peripheral iridotomies streamlines bilateral same-day implantation of EVO lenses (“In the United States, it is common and accepted to perform bilateral same-day sequential surgery.”⁶). However, central port is not limited to improved workflow and patient convenience, important as these are: “Safety data suggest reduced rates of anterior subcapsular cataract and pupillary block compared to previous models. »⁷ The physiological flow of aqueous solution through the central orifice appears to help protect the lens and maintain the open angle. Globally, these safety benefits have led to increased use of EVO lenses for the correction of mild to moderate myopia (outside the United States, EVO is available in powers starting at -0.5 D ).⁸

EVO and EVO+ lenses are available in four sizes that vary in overall diameter: 12.1, 12.6, 13.2 and 13.7 mm. Size is an important factor in the resulting distance between the EVO lens and the lens, a distance known as the arch.

STAAR Surgical provides an online system to calculate the most appropriate size based on corneal white-to-white distance (WTW) and anterior chamber depth (ACD).

The authors described various other methods of measuring the eye and calculating the best-fitting lens, including, but not limited to, ultrasound measurements of the diameter of the ciliary sulcus and optical coherence tomography measurements of eye elevation. lens and angle-to-angle distance. A recent meta-analysis concluded that “no methodology has been shown to be superior in terms of vault predictability to the use of WTW and ACD, which remains the most popular and well-studied technique.”⁹

Regardless of the method, arch variability occurs as a function of the interaction of the EVO lens and the posterior chamber of the eye: “The degree of arch variation is independent of the sizing methodology and is related to the interaction of the lens implant with the anatomy and physiology of the posterior chamber.⁷

Fortunately, the resulting arch range is well tolerated: we know this because the incidence of adverse events is very low. For example, anterior subcapsular cataract (ASC) has previously been associated with low arch; however, “11 publications including data from a total of 617 eyes with a weighted mean follow-up of 13 months reported an incidence of 0.49% asymptomatic ASC opacities”.⁷

The incidence of visually significant cataract was 0.0%. Pupillary block and angle-closure glaucoma have been associated with high arch; however, 38 peer-reviewed publications with safety data from retrospective or prospective series including information on 4196 eyes with a weighted mean follow-up of 14.0 months revealed only one case (0.04% ), which was due to blockage of the central port by “viscoelastic and inflammatory debris”.^ten These data demonstrate that a wide range of skipping is well tolerated.

The efficiency of the EVO ICL lenses is “optically superb”.¹¹ The average efficiency index, uncorrected postoperative visual acuity divided by preoperative corrected visual acuity, is 1.04, and the average uncorrected visual acuity is better than 20/20; 90.8% of the eyes are within 0.50 D and 98.7% are within 1.00 D of the target.⁷ These results are surprisingly similar to those of LASIK¹² and smile.¹³

The benefits of EVO make it very attractive to doctors and patients.EVO offers a simple, bilateral, one-day, in-office procedure that does not permanently damage the eye while providing superb eye correction. a wide range of myopia and astigmatism. With more than one million lenses implanted worldwide, 99.4% of patients say they would have the procedure again7. At the end of the day, you have to admit that this little hole in the lens is a big problem.

Disclosure: Mark Packer is a medical monitor for STAAR Surgical.

References:

1. Kohnen T. Phakic intraocular lenses: Where are we? J Refractory cataract surgery. 2018 Feb;44(2):121-123.

2. Ganesh S, Brar S, Pawar A. Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction of mild to moderate myopic astigmatism. Clin Ophthalmol. 2017 Jul 3;11:1253-1263.

3. Wei R, Li M, Zhang H, Aruma A, Miao H, Wang X, Zhou J, Zhou X. Comparison of objective and subjective visual quality early after V4c implantable collamer lens (V4c ICL) and lenticule extraction with small incision (SMILE) for high myopia correction. Acta Ophthalmol. 2020 Dec;98(8):e943-e950.

4. Vargas V, Alió JL, Barraquer RI, D’Antin JC, García C, Duch F, Balgos J, Alió Del Barrio JL. Safety and visual outcomes after posterior chamber phakic intraocular lens bilensectomy. EyeVis (London). July 1, 2020; 7:34.

5. Approval order. https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030016S035A.pdf (accessed May 17, 2022)

6. Implantable Collamer Lens. https://eyewiki.aao.org/Implantable_Collamer_Lens (Accessed May 17, 2022)

7. Packer M. The collamer implantable central aperture lens: review of the literature. Clin Ophthalmol. 2018;12:2427-2436.

8. Kamiya K, Shimizu K, Igarashi A, et al. Implantation of phakic intraocular lenses in the posterior chamber: a multicenter comparative study in 351 eyes with low to moderate or high myopia. Br J Ophthalmol. Feb;102(2):177-181.

9. Packer M. Meta-analysis and review: efficacy, safety, and design of the central hole intraocular collamer lens. Clin Ophthalmol. 2016;10:1059-1077.

10. Senthil S, Choudhari NS, Vaddavalli PK, Murthy S, Reddy JC, Garudadri CS. Etiology and management of elevated intraocular pressure after implantation of posterior chamber phakic intraocular lenses in myopic eyes. PLoS One. 2016;11(11):e0165469.

11. McLeod SD. Long-term clinical outcomes and rate of cataract formation after posterior phakic lens implantation for myopia. JAMA Ophthalmol. Published online March 3, 2016.

12. Moshirfar M, Shah TJ, Skanchy DF, Linn SH, Kang P, Durrie DS. Comparison and analysis of visual results reported by the FDA of the three latest platforms for LASIK: Wavefront-guided Visx iDesign, Topography-guided WaveLight Allegro Contoura, and Topography-guided Nidek EC-5000 CATz. Clin Ophthalmol. 2017 Jan 4;11:135-147.

13. PMA P150040: FDA Summary of Safety and Efficacy Data; PMA P150040/S003: FDA Summary of Safety and Efficacy Data