Sometimes the best option for a refractive surgery patient is one that is not yet available in the United States. Whether it’s an as-yet-ungranted indication for the patient’s refractive error or a wholly new procedure, these patients cannot obtain the best vision possible in the United States. So, we take them out of the country to get the procedure they need. In doing so, not only do we serve our patients, but we also gain important knowledge about new technologies. Chief among the procedures we’ve performed have been the Implantable Collamer Lens (ICL) and Refractive Lens Exchange (RLE).
INDICATIONS BEYOND OUR BORDERS
For the past few years, we have been performing refractive surgery internationally on select patients who either would not qualify for surgery in the United States or would benefit from more advanced technology not yet approved by the FDA. After a consultation at one of our offices, young moderate and high hyperopes, patients with high myopic astigmatism, and RLE and cataract patients with high astigmatism are given the option of traveling to Costa Rica for the Implantable Collamer Lens (ICL) or a high astigmatism IOL, implanted by me under the direction of Claudio Orlich, MD, medical director of Clinica 20/20 in San José.
In this country, FDA guidelines only allow implantation of the Visian ICL (STAAR Surgical) for treatment of myopia, from -3 to -16 D, and reduction of myopia. from -16 to -23 D.1 The only option for high myopic astigmats in the US (over 2.5 D) is laser vision correction (LASIK or PRK) either before or after ICL implantation, thus doubling the risk of correction.
Internationally, the Visian ICL is available to treat virtually any refractive error:
- The myopic toric ICL can treat high myopic cylinder up to -18 D sphere and -6 D cylinder.
- The hyperopic toric ICL can treat up to +10 D sphere and -6 D cylinder.
- The mixed cylinder ICL can treat up to 6 D of mixed cylinder.2
Table 1 shows the variety of Visian ICL lenses internationally available but are not approved for sale in the United States.
|PRODUCT LABEL||FULL DIOPTER RANGE (D)||CYLINDRICAL POWER (D)|
|VISIAN ICL - HYPEROPIC||+0.5 TO +10.0||N/A|
|VISIAN TORIC ICL - HYPEROPIC||0 TO +10.0||+0.5 TO +6.0|
|EVO VISIAN ICL||-0.5 TO -18.0||N/A|
|EVO TORIC VISIAN ICL||-0.5 TO -18.0||+0.5 TO +6.0|
|EVO+ VISIAN ICL||-0.5 TO -14.0||N/A|
|EVO+ VISIAN TORIC ICL||-0.5 TO -14.0||+0.5 TO +6.0|
THE ICL EDGE
ICL has many benefits compared to LASIK/PRK, including better overall quality of vision, significantly less dry eye, improved night vision, ultraviolet blocking, reversibility and increased accuracy in IOL calculations at the time of future cataract surgery.3 In patients with severe dry eye or other ocular surface disease, corneal scarring, thin or abnormally shaped corneas, large pupils, ICL is an excellent alternative to LASIK or PRK for refractive surgery.4
U.S. patients who have ICL surgery also must undergo a laser or surgical peripheral iridotomy (PI) to prevent angle closure after ICL implantation.
This technology not only increases safety, but also allows for less glare and halo in low light conditions.5 The Visian EVO and EVO+ lenses have a central hole in the middle of the ICL, preventing pupillary block. This version of the lens eliminates the need for a PI and may also decrease anterior capsular cataract risk by allowing the front of the natural lens to be continuously bathed with aqueous. The optical zone varies in the EVO from 4.9 to 5.8 mm, while the EVO+ family ranges from 5.0 to 6.1 mm. A larger optical zone provides better vision in low light with less noticeable glare and haloes.6
Data collected from our first eight patients (16 eyes) who underwent ICL surgery in Costa Rica demonstrated outstanding outcomes with anterior chamber depths as shallow as 2.55 mm. Of the 16 eyes, 10 received a myopic toric ICL and six received a hyperopic or hyperopic toric ICL. Patients who received a myopic toric ICL had a mean manifest refraction spherical equivalent (MRSE) range of -11 D with an average cylinder of 3.35 D. Those who received a hyperopic toric ICL had an average MRSE of +5.67 D and average cylinder of -1.16 D. Extensive preoperative testing, including ultrasound biomicroscopy (UBM), significantly decreases chances of complications postoperatively.
Determining the ICL lens size with a UBM allows for the most accurate and precise sulcus-to-sulcus measurements as well as anterior chamber depth measurements, thus minimizing the risk of anterior capsular cataract and/or IOP spike after surgery.7
PUTTING RLE TO THE TEST
The other unique technology that we offer in Costa Rica is RLE with a high cylinder IOL. Our first case, performed in January 2017, was a 56-year-old Caucasian male with a history of 8-cut radial keratotomy (RK) and 1-cut astigmatic keratotomy (AK) OU. This patient had high corneal astigmatism OD. On the day of his pre-op, he manifested 9 D of corneal cylinder on topography and had +10 D of hyperopia on refraction, with BCVA of 20/25 OD.
Due to the high post-RK corneal astigmatism, this patient was recommended to undergo RLE with a high cylinder Zeiss toric IOL for the right eye. The AT Torbi 709M IOL +22 D sphere with +11D cylinder was sutured onto a capsular tension ring using 10-0 nylon prior to implantation in a technique pioneered by Dr. Orlich in order to prevent IOL rotation. In fact, this foldable IOL has a bitoric optic with cylinder correction in 0.5 D increments up to +12.0 D; it is known for its predictability and excellent rotational stability.8 On the patient’s one-day postop, UCDVA in this eye was 20/60 with a manifest refraction of +2.50 DS correctable to 20/20. By three months postop, his refractive error was +3.00 -1.00 x 045. He underwent successful piggyback IOL implantation for the residual hyperopia.
MORE OPTIONS KEEP THEM COMING
In addition to ICL and IOL technologies not available in the United States, we have access to other technologies in Costa Rica, including trifocal and segment bifocal IOLs. Two years before its FDA approval, I performed SMILE (SMall Incision Lenticule Extraction) with the Zeiss VisuMax laser on appropriate patients. This head start allowed for better adaptability to the platform and its nuances once the technology was approved in the United States.9 Internationally, we are able to customize the laser to different spot size and energy settings, resulting in faster visual recovery.
We currently comanage all these patients with surgeons country-wide. Typically, for ICL, patients will make a single trip to Southern California for a pre-op exam and UBM at one of our centers before meeting us in San José for surgery. If the referring surgeon can access UBM technology, we meet the patient in San José for the first time for treatment.
We perform the postop day-one visit at Clinica 20/20; all other follow-ups and LVC enhancements are performed at the referring surgeon’s office.
Due to an upsurge in viable technology options, refractive surgery has significantly evolved over the years. With currently available refractive technology in the United States and internationally, we can treat virtually any refractive error. OM
- Dougherty PJ, Priver T. Refractive outcomes and safety of the implantable collamer lens in young low-to-moderate myopes. Clinical Ophthalmology (Auckland, N.Z.). 2017;11:273-277.
- Staar Surgical. Evo+ Visian ICL. (2017). [Data file]. Retrieved from http://www.domedics.ch/fileadmin/Images/Files_Neue_Seite/Refraktiv/Downloadfiles_ICL/Evo__Visian_ICL_Surgeon_brochure_Compressed.pdf .
- Parkhurst GD. A prospective comparison of phakic collamer lenses and wavefront-optimized laser-assisted in situ keratomileusis for correction of myopia. Clinical Ophthalmology (Auckland, NZ). 2016;10:1209-1215.
- Sanders D, Vukich JA. Comparison of implantable contact lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006;25:1139-1146.
- Rivera RP, Dougherty PJ, Bernitsky D, Yazzie D. Short-interval bilateral surgery for implantation of the Visian implantable collamer lens: nonrandomized multicenter retrospective analysis of 328 consecutive eyes. Journal of Refractive Surgery. Submitted.
- Shimizu K, Kamiya K, Igarashi A, Kobashi H. Long-term comparison of posterior chamber phakic intraocular lens with and without a central hole (hole ICL and conventional ICL) implantation for moderate to high myopia and myopic astigmatism: consort-compliant article. Medicine. 2016;95:e3270.
- Dougherty PJ, Rivera RP, Schneider D, et al. Improving accuracy of phakic IOL (Visian ICL- Staar Surgical) sizing utilizing high frequency ultrasound (UBM) with the Sonomed Vumax IL. J Catar Refract Surg. 2010;37:13-18.
- Bascaran L, Mendicute J, Macias-Murelaga B, Arbelaitz N, Martinez-Soroa I. Efficacy and stability of AT TORBI 709 M toric IOL. J Refract Surg. 2013;29:194-199.
- VisuMax Femtosecond Laser. Small Incision Lenticule Extraction (SMILE) procedure for the correction of myopia. (2016). [Data file]. Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150040D.pdf .