A Broader Role for Phakic IOLs

Expanding Candidacy

By Erik L. Mertens, MD, FEBO, FWCRS, FEBOS-CR

Posterior chamber phakic IOLs have traditionally occupied a defined role in refractive surgery. For many years, surgeons primarily considered these implants for patients who were not ideal candidates for corneal laser procedures because of high myopia, insufficient corneal thickness, ocular surface disease, or other anatomic considerations. In many practices, phakic IOL implantation was viewed as an alternative solution when laser vision correction was unlikely to provide the desired outcome.

Advances in lens design, imaging technology, sizing methods, and long-term outcomes have broadened the group of patients who may benefit from a phakic IOL. Increasingly, these lenses are being considered not only for highly myopic eyes but also for patients with lower refractive errors who might previously have been directed toward LASIK or keratorefractive lenticule extraction.

A Broader Primary Option

A key development has been an expansion of the approved treatment range. In the United States, the EVO Visian ICL (STAAR Surgical) is approved for the correction or reduction of -3.00 to -20.00 D of myopia.¹ Outside the United States, indications vary by market and may include lower amounts of myopia. These refractive errors are well below the range traditionally associated with phakic IOL implantation and include many patients who, only a few years ago, would have been considered straightforward candidates for laser vision correction.

National and multicenter studies have demonstrated favorable safety, efficacy, predictability, and stability data on the EVO ICL in eyes with low and moderate myopia, not only in highly myopic patients for whom the technology was originally developed.^2,3 In daily practice, many surgeons now discuss phakic IOLs earlier in the consultation process rather than only after corneal refractive surgery has been excluded.

In 2026, STAAR Surgical announced that the US FDA had expanded the approved age indication for the EVO ICL from a range of 21 to 45 years to between 21 and 60 years.⁴ This change is particularly relevant for patients with early presbyopia, in whom the preservation of corneal tissue and future treatment flexibility can be advantageous.

Market trends appear to mirror these developments. Data from an analysis of 19 practices conducted by the American-European Congress of Ophthalmic Surgery showed that the EVO ICL accounted for 72% of refractive procedures in patients with at least -8.00 D of myopia.⁴ These findings suggest that experienced refractive surgeons increasingly regard phakic IOL implantation as a preferred treatment option rather than only an alternative when laser surgery is unsuitable.

Anatomic Eligibility

Ocular anatomy still excludes some patients from receiving a posterior chamber phakic IOL. An anterior chamber depth of at least 3.00 mm in hyperopic eyes and 2.80 mm in myopic eyes has generally been required for implantation, limiting treatment options particularly for hyperopic patients, who often have shorter eyes and shallower anterior segments.

A new posterior chamber phakic IOL, the AmiLens Phakic (Amiplant), has been developed specifically to address this challenge. The lens features a Fresnel rather than a conventional refractive optic, which reduces the thickness of its profile. This is particularly important in hyperopic corrections, which traditionally require the thickest phakic IOLs.

A thinner lens occupies less space within the anterior segment and could allow treatment of eyes that would previously have fallen outside conventional anatomic criteria, provided the angle anatomy is suitable. The hyperopic AmiLens Phakic also incorporates a central port, which is intended to eliminate the need for peripheral iridotomy or iridectomy and reduce concerns regarding pupillary block in shallow hyperopic eyes.

As with any emerging technology, long-term clinical data are required to determine the AmiLens Phakic's role. The design could expand patient eligibility for posterior chamber phakic IOL implantation, but the product's clinical value depends on its safety, vault behavior, optical quality, and regulatory availability.⁵

Revisiting Historical Concerns

The caution demonstrated by some surgeons reflects their experience with earlier lens generations. Those concerns remain relevant, but modern lenses featuring a central port and improved sizing methods have changed the risk discussion.

Pupillary Block

Historically, the prevention of pupillary block required a preoperative peripheral iridotomy. The introduction of the KS-AquaPort central port with the V4c model of the ICL, subsequently incorporated into the EVO platform, changed aqueous humor circulation through the lens. A routine iridotomy is no longer required.² In the US FDA clinical trial of the EVO and EVO+ lenses, no cases of pupillary block or pigment dispersion syndrome were reported.⁶

Vault Predictability

The vault remains an important determinant of long-term safety. Fortunately, vault prediction has improved meaningfully over the past decade.

Modern anterior segment OCT systems provide direct measurements of relevant anatomic structures instead of relying primarily on white-to-white distance and anterior chamber depth measurements. In addition, dedicated sizing formulas, including the LASSO (least absolute shrinkage and selection operator) formulas developed by my group and the Russo formula incorporated into the MS-39 (CSO), have demonstrated improved postoperative vault prediction compared with traditional manufacturer nomograms.^7,8

Ultrasound biomicroscopy provides a complementary approach. The ICL Guru software platform uses AI and ultrasound biomicroscopy-derived measurements of the sulcus and ciliary body to estimate the postoperative central and peripheral vault. Validation studies from several international centers have demonstrated the tool's promising predictive accuracy.⁹

Although vault assessment remains challenging, it has become considerably more precise.

Endothelial Cell Loss

Endothelial safety remains an important consideration whenever intraocular surgery is discussed. Earlier phakic IOL designs, particularly some anterior chamber and iris-fixated models, raised legitimate concerns regarding long-term endothelial cell loss.

The current generation of posterior chamber lenses that have a central port appears to have a different safety profile than earlier generations. In the US FDA clinical trial of the EVO ICL, endothelial cell density (ECD) declined by 2.3% at 6 months, a safety index of 1.24 was maintained, and no anterior subcapsular cataract formation was reported.¹⁰ Long-term follow-up studies extending to 8 years have reported mean ECD loss of approximately 3.6%.¹⁰

These findings are reassuring, but a preoperative ECD assessment and long-term monitoring are still necessary. The available evidence suggests that endothelial concerns associated with earlier phakic IOL designs should not be automatically applied to modern lenses that feature a central port.

Why Adoption Varies

Adoption patterns for phakic IOLs continue to vary considerably between surgeons and regions.

One factor is that phakic IOL implantation is an intraocular procedure. Another is a distinction between corneal and intraocular surgery. Procedural costs, reimbursement structures, OR logistics, and patient expectations also differ significantly among markets.

Additionally, treatment algorithms often evolve more slowly than technology. Many surgeons developed their indications for phakic IOLs during an era when sizing methods were less precise, central ports did not exist, and long-term safety data were more limited. As a result, some patients who might benefit from a phakic IOL may still be directed toward corneal refractive surgery.

Removability is another consideration. Although no refractive procedure should be considered entirely reversible, a phakic IOL preserves corneal tissue and can be removed or exchanged if necessary. This can be a meaningful advantage for some patients, particularly younger individuals with healthy crystalline lenses.

Conclusion

Modern phakic IOLs deserve discussion earlier in the refractive surgery conversation. In addition to highly myopic patients, those with moderate amounts of myopia, individuals with borderline corneal parameters, those in whom corneal thickness is a concern, and select individuals with hyperopia could benefit from this technology.

The question is no longer whether phakic IOLs are appropriate only when laser surgery is contraindicated. It is whether modern phakic IOL technology should be discussed in addition to corneal refractive procedures as part of the primary treatment conversation.

References

1. EVO/EVO+ Visian Implantable Collamer Lens (ICL). Premarket approval application P030016/S035. Silver Spring, MD: US Food and Drug Administration; approved March 25, 2022. Accessed July 7, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030016S035C.pdf
2. Kamiya K, Shimizu K, Igarashi A, et al; Japan ICL Study Group. A nationwide multicenter study on 1-year outcomes of posterior chamber phakic intraocular lens implantation for low myopia. Front Med (Lausanne). 2022;9:762153. doi:10.3389/fmed.2022.762153
3. Kamiya K, Shimizu K, Igarashi A, 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):177-181. doi:10.1136/bjophthalmol-2017-310164
4. STAAR Surgical Company. FDA expands U.S. age indication for EVO ICL as long-term safety data reinforces market shift away from laser vision correction. News release. Lake Forest, CA: STAAR Surgical; February 17, 2026. Accessed July 7, 2026. https://investors.staar.com/news-and-events/press-releases/2026/02-17-2026-210124036
5. Mertens ELJG. A low-profile Fresnel posterior chamber phakic IOL with a built-in vault (AMILens Phakic IOL): expanding candidacy in shallow and hyperopic eyes. Presented at: AECOS Europe Symposium; June 11-14, 2026; Madrid, Spain.
6. 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. Clin Ophthalmol. 2022;16:1541-1553. doi:10.2147/OPTH.S369467
7. Rocamora L, Orlando JI, Lwowski C, Kohnen T, Mertens E, Van Keer K. Postoperative vault prediction for phakic implantable collamer lens surgery: LASSO formulas. J Cataract Refract Surg. 2023;49(2):126-132. doi:10.1097/j.jcrs.0000000000001079
8. Russo A, Filini O, Savini G, et al. Predictability of the vault after implantable collamer lens implantation using OCT and artificial intelligence in White patient eyes. J Cataract Refract Surg. 2023;49(7):724-731. doi:10.1097/j.jcrs.0000000000001182
9. Zaldivar R, Zaldivar R, Cummings AB, et al. Evaluating the predictive accuracy of an AI-based tool for postoperative vault estimation in phakic intraocular lens implantation. Clin Ophthalmol. 2025;19:1945-1956. doi:10.2147/OPTH.S529187
10. Kamiya K, Shimizu K, Takahashi M, Ando W, Hayakawa H, Shoji N. Eight-year outcomes of implantation of posterior chamber phakic intraocular lens with a central port for moderate to high ametropia. Front Med (Lausanne). 2021;8:799078. doi:10.3389/fmed.2021.799078

Preserving Future Lens-Based Options

By Rex Hamilton, MD, MS, FACS

When I evaluate a patient for vision correction, I start with their age. For patients younger than 40 years of age, I usually choose between a corneal procedure and a phakic IOL. For those 50 years of age or older, I consider an IOL-based solution almost exclusively. Between those two poles sits the group for whom my thinking about phakic IOLs has changed the most during the past 5 years.

Two developments have driven that change. First, the release of the EVO ICL - the version with a central port in the optic - eliminated the need for a peripheral iridotomy and introduced a more physiologic pathway for aqueous flow.¹ Second, in November 2025, the US FDA expanded the approved age range for the EVO ICL up to 60 years.² Together, those changes have made the EVO ICL a much more attractive option than the previous generation of the lens and expanded the pool of candidates to include patients 40 to 50 years of age and, in select cases, those in their early 50s.

A More Streamlined Procedure

I performed my first ICL case in 2005. Back then, I routinely paired ICL implantation with a peripheral iridotomy, typically performed with an Nd:YAG laser on a day before the implantation surgery. This additional step took time, required a separate procedure, and was often painful - and patients were understandably uneasy about the idea of creating a hole in their iris. The discomfort associated with the laser peripheral iridotomy was particularly unfortunate because it preceded the painless implantation procedure and could therefore cause unnecessary anxiety in patients as they anticipated the next step.

The central opening in the EVO ICL streamlines the procedure and allows more physiologic aqueous flow from the posterior chamber to the anterior chamber. Evidence also suggests that this design reduces the risk of premature cataract formation.¹ In practical terms, the EVO ICL offers a more convenient patient experience. In my hands, the procedure takes about 5 minutes per eye, and I perform immediate sequential bilateral surgery. Patients' recovery is quick, and their overall experience is similar to what patients expect from LASIK. That parallel matters because LASIK is the reference point most refractive surgery patients bring to the consultation.

Counseling Patients in the Expanded Age Range

The expanded EVO ICL indication has changed how I counsel patients in the presbyopic age range. When an individual in their mid- to late 40s presents for a refractive surgery evaluation, they are often already presbyopic, so a phakic IOL or a corneal procedure such as LASIK or keratorefractive lenticule extraction requires a blended vision plan - a plano target in one eye and a chosen level of myopia in the fellow eye based on their age and needs. Because no hyperopic phakic IOL has been approved by the US FDA, the phakic IOL conversation applies specifically to myopic patients in this age range.

In those with higher amounts of myopia (≥ -6.00 D), I am reluctant to move directly to a refractive lens exchange (RLE) because of the risk of retinal complications, such as a retinal tear or retinal detachment. Retinal OCT imaging is used to assess them for a posterior vitreous detachment (PVD). If a complete PVD is confirmed, the retinal risk profile of RLE improves substantially, and I am more comfortable moving in that direction. If a complete PVD is not present, I recommend a phakic IOL with a blended vision plan as a bridge until the patient develops a PVD.

Motivation and follow-up reliability are the other variables I weigh. A highly motivated patient who is frustrated with their glasses and has not done well with multifocal contact lenses may be ready for a surgical solution. When presbyopic patients choose a phakic IOL, I make it clear upfront that it is not a lens for the rest of their lives. That framing is critical.

If I am considering an RLE in a patient without a complete PVD, I emphasize the need for ongoing retinal surveillance. I want them to have a preoperative examination with a retina specialist and return for postoperative follow-up every 6 months for at least a few years so developing retinal pathology is not missed. If the patient commits to that follow-up, we may proceed with an RLE.

Preserving Future Options in Patients With High Myopia

There is another reason I favor a phakic IOL over a corneal procedure for higher corrections. LASIK or keratorefractive lenticule extraction permanently alters the shape of the cornea. For corrections greater than roughly -7.00 to -8.00 D, a corneal procedure can induce enough positive spherical aberration that the resulting corneal optics may no longer be compatible with current multifocal IOL optics when that patient needs an RLE in the future. In other words, this corneal procedure today could close the door on some presbyopia-correcting options at the time of RLE or cataract surgery.

A phakic IOL preserves that option. When the patient eventually needs an RLE or cataract surgery, the EVO ICL can be removed. The cornea retains its natural shape. That reversibility is a major reason I am more interested in a phakic IOL for patients with higher degrees of myopia.

Where a Presbyopia-Correcting Phakic IOL Would Fit

A presbyopia-correcting phakic IOL is not currently available in the United States, where I practice, but the category is worth watching. Two designs have received attention outside the United States: the EVO Viva ICL, which has a refractive optic, and the presbyopic IPCL (Care Group), which has a bifocal diffractive optic.

The EVO Viva ICL's extended depth of focus design avoids an intermediate trough in vision. Although clinical results have been quite good,³ the efficacy of this design may be more limited for reading small print near vision and slightly more sensitive to decentration, with a consequent effect on quality of vision.

The IPCL has also shown promising clinical results.⁴ Patients, however, should be cautioned that a bifocal diffractive design is associated with a trough in the intermediate range because the two primary focal points are distance and near. One might counsel these patients that they may need low-powered readers for prolonged computer work, for example.

A phakic IOL with a trifocal or continuous-range diffractive design would be a useful addition to the toolbox. A myopic patient in their late 40s or early 50s without a complete posterior vitreous detachment in whom I am reluctant to pursue refractive lens exchange could benefit from a presbyopia-correcting phakic IOL.

References

1. Packer M. The Implantable Collamer Lens with a central port: review of the literature. Clin Ophthalmol. 2018;12:2427-2438. doi:10.2147/OPTH.S188785
2. STAAR Surgical Company. FDA expands U.S. age indication for EVO ICL as long-term safety data reinforces market shift away from laser vision correction. News release. Lake Forest, CA: STAAR Surgical; February 17, 2026. Accessed July 7, 2026. https://investors.staar.com/news-and-events/press-releases/2026/02-17-2026-210124036
3. Alfonso JF, Fernández-Vega-Cueto L, Lisa C, Alfonso-Bartolozzi B, Palacios A, Madrid-Costa D. Clinical and aberrometric outcomes of a new implantable collamer lens for myopia and presbyopia correction in phakic patients. J Refract Surg. 2023;39(9):589-596. doi:10.3928/1081597X-20230726-02
4. Bianchi GR. Initial results from a new model of posterior chamber implantable phakic contact lens: IPCL V2.0. Med Hypothesis Discov Innov Ophthalmol. 2019;8(2):57-63.