Phakic Intraocular Lenses: An Update and Review for the Treatment of Myopia and Myopic Astigmatism in the United States

Majid Moshirfar; Court R. Webster; Yasmyne C. Ronquillo

Curr Opin Ophthalmol. 2022;33(5):453-463.

Abstract and Introduction

Abstract

Purpose of Review: To review all phakic intraocular lenses (pIOLs) available in the United States for the correction of myopia or myopic astigmatism and offer a clinical approach to their proper use, postoperative follow-up, and analysis of visual and adverse outcomes.

Recent Findings: In March 2022, the FDA approved the EVO/EVO+ Visian ICL for widespread use, adding this lens to the two others available (Verisyse, Visian ICL). Cataract formation, endothelial cell loss (ECL) and surgical reintervention remain the most common adverse events. There are discrepancies between studies on ECL following implantation with pIOLs, although trends can be deduced with meta-analysis. Posterior Chamber-pIOLs (PC-pIOLs), especially the EVO/EVO+, have an overall lower mean adverse effect and subjective patient symptom profile when compared to Iris Fixated-pIOLS (IF-pIOLs). Advancements in PC-pIOL sizing have provided a noticeable difference in visual and safety outcomes.

Summary: All pIOLs available in the United States provide high-quality visual correction of moderate to high myopia and/or myopia with astigmatism. Proper follow-up for ECL and cataract formation is warranted.

Introduction

The first phakic intraocular lenses (pIOLs) implanted by Benedetto Strampelli in 1953, consisted of a rigid angle-supported design.^[1] From the 1970 s to the early 2010 s, multiple different angle-supported lens materials were used with various complications, including corneal decompensation and pupil malformation. Eventually, all angle-supported lenses were removed from the global market. Iris-supported lenses, pioneered by Cornelis Binkhorst in 1953, and improved by Jan Worst in 1978, have led to the iris-enclavation technique that is still used today.^[1] Posterior chamber (PC) pIOLs were first implanted in the 1990 s and offered another alternative with fewer side effects. The use of these devices for the correction of myopia with or without astigmatism has become a popular topic in the ophthalmology community with the recent announcement of a new phakic IOL and the number of recipients of PC-pIOLs surpassing one million.

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Next Section

Abstract and Introduction
Text of Review
Toric Phakic Intraocular Lenses
Corneal Endothelial Cell Loss
Cataracts
Retinal Complications
Improper Posterior Chamber-phakic Intraocular Lenses Sizing
Lens Explantation
Conclusion
References
Sidebar

Table 1. Comparison of FDA Approved Phakic IOLs.
		Verisyse (Artisan)^d,e [10]	Visian ICL [11]	Visian Toric ICL [12]	EVO/EVO+ Visian ICL [7]	EVO/EVO+ Visian Toric ICL [7]
Class of pIOL		Iris-supported	PC-supported (flexible)	PC-supported (flexible)	PC-supported (flexible)	PC-supported (flexible)
Manufacturer		Johnson & Johnson	Staar Surgical	Staar Surgical	Staar Surgical	Staar Surgical
FDA Approval		Sept. 10, 2004	Dec. 22, 2005	Sept. 13, 2018	March 25, 2022	March 25, 2022
Lens Material		PMMA^a	Collamer^b	Collamer	Collamer	Collamer
Optic Diameter		Model 204: 6.0mm Model 206: 5.0mm	4.9–5.8mm	4.9–5.8mm	EVO 4.9–5.8mm EVO+ 5.0–6.1mm	EVO 4.9–5.8mm EVO+ 5.0 to 6.1mm
Spherical Power Available		Model 204: -5.0D to -15.5D Model 206: -5.0D to -20D	−3.0D to −16.D	−3.0D to −16.D	EVO −3.0D to −16.0D EVO+ -3.0D to -14.0D	EVO −3.0D to −16.0D EVO+ -3.0D to -14.0D
Cylindrical Power Available		≤2.5D	≤2.5D	1.0D to 4.0D	≤2.5D	1.0D to 4.0D
Patient Inclusion Criteria	Age	≥21 y.o	21–45 y.o.	21–45 y.o.	21–45 y.o.	21–45 y.o.
	MRSE	-5.0D to -20.0D Stable MR±0.5D for 6 months	correct -3.0D to ≤-15D reduce -15.0D to -20D Stable MR±0.5D for 1 year	see Visian ICL	see Visian ICL	see Visian ICL
	Aqueous Depth (AD)^c	≥3.2mm	≥3.0mm	≥3.0mm	≥3.0mm	≥3.0mm
	ECD	minimum met (Table 2)	minimum met (Table 2)	minimum met (Table 2)	minimum met (Table 2)	minimum met (Table 2)
	AC angle^f	NR	>grade II	>grade III	>grade III	>grade III

^aRigid Perspex CQ-UV (a UV light absorbing PMMA-Polymethylmethacrylate [13].
^bHEMA-hydroxyethyl methacrylate, a porcine-collagen based biocompatible polymer.
^cAqueous depth is measured from the posterior cornea to the anterior surface of the crystalline lens
^dVerisyse toric available in -22D to 14.0 spherical, -1D to -7.5D cylindrical (with limitations) outside the US only.
^eVeriflex (Artiflex) toric available in -1.0D to -13.5D spherical, -1.0D to -5.0D outside the US only.
^fAC angle determined by gonioscopy; classification system was not specified. It is unclear why grade II vs grade III between Visian ICL and toric ICL.

Table 2. Staar Surgical Minimum ECD for Age and Aqueous Depth (AD).
Age	Staar Surgical (Visian ICL, EVO/EVO+)			Verisyse
Age	Minimum ECD AD ≥3.0mm (cells/mm2)	Minimum ECD AD ≥3.2 mm (cells/mm2)	Minimum ECD AD ≥3.5 mm (cells/mm2)	Minimum ECD (cells/mm2) AD ≥3.2mm
21–25	3875	3800	3250	3350
26–30	3425	3375	2900	3175
31–35	3025	2975	2625	2825
36–40	2675	2625	2350	2500
41–45	2350	2325	2100	2225
>45	2075	2050	1900	2000