Phakic Intraocular Lenses





KEY CONCEPTS





  • Both anterior and posterior chamber phakic intraocular lenses (PIOL) are safe and effective options for visual rehabilitation in patients with stable, mild-moderate keratoconus (KC).



  • In cases of progressive KC, corneal cross-linking (CXL) should be performed to halt the progression of the disease, prior to considering PIOL implantation. The timing between CXL and PIOL implantation should be individualized, usually after confirmed topographic and refractive stabilization.



  • Intrastromal corneal ring segment (ICRS) implantation may be combined with PIOL implantation for correction of moderate-high refractive error in eyes with nonadvanced KC and significant irregular astigmatism.



  • Phakic IOLs are safe and effective in correcting postkeratoplasty ametropia in KC eyes in the mid/long term.



Introduction


The two most important goals in the management of keratoconus (KC) are halting disease progression and visual rehabilitation. Visual rehabilitation in KC patients is a challenge, usually requiring a stepwise approach: first stabilizing the disease if progression is present; then regularizing the corneal shape; and, finally, correcting the spherocylindrical error. , Phakic intraocular lenses (PIOLs) have been increasingly used for the correction of moderate-high levels of myopia and regular astigmatism in KC eyes, and reduction of the refractive difference between both eyes. By reducing the degree of anisometropia, PIOLs improve binocularity, as retinal images become more similar. In addition, PIOLs provide a larger image size compared with spectacles. Finally, PIOLs in KC eyes do not affect the corneal surface, unlike other strategies such as intrastromal corneal ring segments (ICRSs) or photorefractive keratectomy (PRK).


Studies of PIOLs in eyes with KC include anterior chamber (AC) iris-claw PIOLs and posterior chamber (PC) PIOL ( Table 30.1 ). In appropriately selected patients with KC, PIOL implantation has shown a good efficacy index (postoperative uncorrected distance visual acuity [UDVA]/preoperative corrected distance visual acuity [CDVA] ratio), as well as a good safety index (postoperative CDVA/preoperative CDVA ratio), with low rates of complication ( Tables 30.2 and 30.3 ). , , Iris-claw AC PIOLs (Artisan and Artiflex, Ophtec BV, Groningen, The Netherlands) are fixated anteriorly to the iris by enclavation, effectively correcting spherocylindrical error. In our experience, advantages of the iris-claw concept include centration, fixation, positioning in the AC, and respect for the anatomy of the anterior segment. , We use Toric Artiflex in most cases of stable, mild-to-moderate KC, and only consider the polymethyl methacrylate (PMMA) Artisan PIOL if spherical power is less than −14.50 D and/or cylinder power is greater than 5.00 D. Aiming for emmetropia or slight undercorrection results in significant improvement of cylinder and manifest refraction, as well as significant improvement in both UDVA and CDVA in eyes with stable, nonadvanced KC. Most patients gain ≥1 lines of CDVA ( Table 30.2 ). The Visian ICL (EVO Visian ICL, STAAR Surgical Co., Monrovia, CA, USA) is a PC PIOL with a superior postoperative visual performance and with high safety and effectiveness profiles for the correction of moderate-high ametropia. Long-term visual and refractive stability has been demonstrated after implantable collamer lens (ICL) implantation in eyes with stable, mild-to-moderate KC, with most eyes reaching UDVA ≥20/40, and a high percentage of eyes reaching UDVA in the 20/25 to 20/20 range (see Table 30.3 ).



TABLE 30.1

Characteristics of Iris-Claw and Posterior Chamber Phakic Intraocular Lenses





























































Trademark Material/Design Optic Overall Diameter (mm) Power (D) IOL Power Calculation
Iris-Claw
Nonfoldable Artisan Single-piece CQ UV PMMA 5.0–6.0 mm diameter 8.5 Myopia −3.00 D to −23.50 D (0.50 D increments) Van der Heijde formula (based on patient’s refractive error, AC depth, and keratometry)
Hyperopia +2.00 D to +12.00 D (0.50 D increments)
Artisan Toric Single-piece CQ UV PMMA Spherical anterior surface and spherocylindrical posterior surface 8.5 Sphere +12.00 D to −23.50 D
5.0 mm diameter Torus 1.00 D to 7.50 D
Foldable Artiflex Myopia CQ UV PMMA haptics + polysiloxane optic Foldable, 6.0-mm optic 8.5 Myopia −2.00 D to −14.50 D (0.50 D increments)
Artiflex Toric CQ UV PMMA haptics + polysiloxane optic Foldable, 6.0-mm optic, spherical anterior surface and spherocylindrical posterior surface 8.5 Sphere −2.00 D to −14.50 D
Torus 1.00 D to 5.00 D
Posterior Chamber
EVO Visian (ICL and Toric ICL) Rectangular, single-block lens with plate-haptic design Foldable, convex-concave, collamer (porcine scleral tissue-derived hydrophilic, biocompatible material) 12.1, 12.6, 13.2, and 13.7 Sphere −0.50 D to −20.00 D Power determined using manufacturer’s software; TICL power calculation by manufacturer, using astigmatism decomposition method
Torus 0.50 D to 6.00 D
4.9–5.8 mm diameter

AC, Anterior chamber; ICL, implantable collamer lens; IOL, intraocular lens; PMMA, polymethyl methacrylate; TICL, toric implantable collamer lens.


TABLE 30.2

Reported Outcomes and Complications of Iris-Claw Anterior Chamber Phakic Intraocular Lens Implantation in Keratoconus



































































































































































Preoperative Data
Author Publication (Year) Eyes (n) UDVA (logMAR) CDVA (logMAR) Sphere (D) Cylinder (D) RSE (D) ECC (cells/mm 2 )
Budo et al. 2005 6 N/R 0.32 ± 0.13 −12.00 ± 10.14 −3.75 ± 1.28 −13.88 ± 10.22 N/R
Moshirfar et al. 2006 2 CF in all patients 0.25 ± 0.05 −13.50 ± 1.80 3.80 ± 1.30 −11.63 ± 2.40 1904.5 ± 114.5
Venter 2009 18 N/R 0.13 ± 0.13 −4.64 ± 2.74 −3.07 ± 20.4 −6.17 ± 2.39 2644 ± 401
Kato et al. 2011 36 1.39 ± 0.42 N/R N/R 2.44 ± 2.25 −8.38 ± 3.42 N/R
Sedaghat et al. 2011 16 CF in all patients 0.21 ± 0.14 −12.5 ± 4.61 −2.95 ± 4.06 −13.90 ± 4.61 N/R
Postoperative Data
Follow-Up (Months) UDVA(logMAR) CDVA (logMAR) %UDVA ≥20/40 %Gain CDVA ≥1 lines %Eyes CDVA loss ≥2 lines Sphere (D) Cylinder (D) RSE (D) %eyes RSE ± 0.50 D %eyes RSE ± 1.00 D ECL (%) Complications SI EI
6 N/R 0.17 ± 0.09 N/R 83.3% 0.0% 0.38 ± 0.79 −1.16 ± 1.24 −0.21 ± 1.13 20% 66.67% N/R Mild glare (33.3%) 1.49 N/R
2 and 12 0.25 ± 0.05 0.20 ± 0.00 100% 50.0% 0.0% −0.13 ± 0.13 3.13 ± 1.13 1.43 ± 0.69 0.00% 50.00% <4% None reported 1.13 ± 0.13 2.40 ± 0.74
6–12 0.12 ± 0.09 0.00 ± 0.05 100% 72.0% 0.0% −0.03 ± 0.47 −0.86 ± 0.55 −0.46 ± 0.60 61.10% 83.30% 6.30% KC progression (5.6%) 1.38 ± 0.48 1.07 ± 0.41
12 0.02 ± 0.21 N/R N/R 38.9% 0.0% N/R 0.62 ± 0.69 −0.42 ± 0.89 63.60% 83.60% N/R Wound recession requiring resuturing (2.8%) 1.16 ± 0.31 0.87 ± 0.31
14.2 ± 7.8 0.15 ± 0.13 0.11 ± 0.10 100% 68.8% 0.0% −0.03 ± 1.81 −2.08 ± 1.04 −0.90 ± 1.90 33.30% 53.30% N/R Sterile uveitis requiring oral corticosteroid (12.5%) 1.36 ± 0.43 1.19 ± 0.37

CDVA, Corrected distance visual acuity; CF, counting fingers; D, diopters; ECC, endothelial cell count; ECL, endothelial cell loss; EI, efficacy index (postoperative UDVA/preoperative CDVA ratio); KC, keratoconus; N/R, not reported; RSE, refractive spherical equivalent; SI, safety index (postoperative CDVA/preoperative CDVA ratio); UDVA, uncorrected distance visual acuity.


TABLE 30.3

Reported Outcomes and Complications of Posterior Chamber Phakic Intraocular Lens Implantation in Keratoconus























































































































































































































Preoperative Data
Author Publication (Year) Eyes (n) UDVA (logMAR) CDVA (logMAR) Sphere (D) Cylinder (D) RSE (D) ECC (cells/mm 2 ) Follow-Up (Months)
Kamiya et al. 2008 2 1.28 0.05 −9.00 ± 1.00 −4.38 ± 1.63 −11.19 ± 1.84 2541.5 ± 715.5 3.00
Alfonso et al. 2008 25 N/R 0.15 ± 0.15 −8.54 ± 4.15 −1.24 ± 1.19 −9.13 N/R 12.00
Alfonso et al. 2010 30 N/R 0.12 ± 0.10 −3.64 ± 3.27 −3.48 ± 1.24 −5.38 ± 3.26 2525 ± 414 12.00
Kamiya et al. 2011 27 1.51 ± 0.20 −0.11 ± 0.08 N/R −3.03 ± 1.58 −10.11 ± 2.46 2734 ± 482 6.00
Hashemian et al. 2013 22 N/R 0.23 −3.59 ± 2.59 −2.77 ± 0.99 −4.98 ± 2.63 N/R 6.00
Kamiya et al. 2014 21 1.46 ± 0.15 −0.07 ± 0.07 N/R −3.21 ± 1.56 −9.70 ± 2.33 2793 ± 455 36.00
Hashemian et al. 2018 23 All eyes were in the CF range 0.24 ± 0.14 −3.78 ± 2.64 −3.14 ± 1.58 −5.35 ± 2.80 2713 ± 250 60.00
Postoperative Data
UDVA(logMAR) CDVA(logMAR) %UDVA ≥20/40 %Gain ≥1 line CDVA %Loss ≥2 lines CDVA Sphere (D) Cylinder (D) RSE (D) %RSE within ± 0.50 D %RSE within ± 1.00 D %ECL Complications SI EI
0.07 ± 0.03 −0.08 ± 0.08 100.0% 100% 0% 0.13 ± 0.38 −1.13 ± 0.13 −0.44 ± 0.44 50% 100% N/R None reported 1.38 ± 0.13 0.95 ± 0.05
0.17 ± 0.19 0.12 ± 0.12 96.0% 20% 0% −0.08 ± 0.23 −0.46 ± 0.72 −0.32 ± 0.55 84% 100% N/R None reported 1.05 0.98
0.09 ± 0.11 0.07 ± 0.08 96.7% 97% 0% 0.09 ± 0.34 0.41 ± 0.61 −0.08 ± 0.37 86.7% 100% 2.61% None reported 1.16 1.07
−0.09 ± 0.16 −0.15 ± 0.09 100.0% 48% 0% N/R −0.56 ± 0.75 0.10 ± 0.43 85% 96% 4.40% None reported 1.12 ± 0.18 1.01 ± 0.25
0.15 0.10 86.4% 77% 0% 0.28 ± 0.42 −1.25 ± 0.65 −0.33 ± 0.51 68.2% 90.9% N/R None reported 1.40 ± 0.32 1.24 ± 0.34
−0.06 ± 0.11 −0.12 ± 0.09 100.0% 53% 0% N/R −0.62 ± 0.79 −0.02 ± 0.53 67% 86% 4.40% PIOL rotation requiring repositioning (5%) N/R N/R
N/R 0.06 ± 0.09 100.0% 83% 0% 0.00 ± 0.76 −1.56 ± 1.53 −0.78 ± 1.31 N/R N/R 7.88% PIOL rotation requiring repositioning (21.7%) 1.58 1.33

CDVA, Corrected distance visual acuity; D, diopters; ECC, endothelial cell count; ECL, endothelial cell loss; EI, efficacy index (postoperative UDVA/preoperative CDVA ratio); N/R, not reported; PIOL, phakic intraocular lens; RSE, refractive spherical equivalent; SI, safety index (postoperative CDVA/preoperative CDVA ratio); UDVA, uncorrected distance visual acuity.


Patient Selection


Potential candidates for PIOL implantation include patients with stable or stabilized mild-moderate KC who have moderate-high ametropia and who do not have satisfactory best-corrected visual acuity (BCVA) ( Fig. 30.1 ). The term “satisfactory BCVA” has been adopted to differentiate patients who achieve good corrected vision but are unable to tolerate or wear optical correction for long periods of time, including contact lenses (CL). Exclusion criteria for PIOL implantation include low endothelial cell counts (ECC), according to patient age and for each PIOL; short AC depth; abnormal iris or pupil function; and a scotopic pupil size >6.00 mm ( Box 30.1 ). Preoperative CDVA should be ≥20/50, as keratoplasty may achieve superior visual outcomes in these cases. It has been suggested that KC patients with ECC of 2000 cells/mm 2 or slightly below may still be candidates for PIOL implantation, as a measure to delay or prevent the need for penetrating keratoplasty (PK). However, with the increasing experience with deep anterior lamellar keratoplasty (DALK) and given the advantages of DALK over PK in KC, our group usually excludes patients with ECC <2300 cells/mm 2 for PIOL implantation, as these patients may fare better with DALK. In cases of documented progression, halting disease progression must be addressed before considering PIOL implantation either by corneal cross-linking (CXL) or by corneal transplantation (DALK or PK) (see Chapter 8). Commonly used criteria to determine progression include clinical and topo-tomographic parameters ( Box 30.2 ); consistent changes over two consecutive examinations spaced 6 to 12 months apart are needed to determine progression. However, no clear definition of progression is available.




Fig. 30.1


Proposed decision tree for the management of keratoconus. CDVA, Corrected distance visual acuity; CL, contact lens; CXL, corneal cross-linking; DALK, deep anterior lamellar keratoplasty; ECC, endothelial cell count; ICRS, intrastromal corneal ring segments; KC, keratoconus; PIOL, phakic intraocular lens; PK, penetrating keratoplasty; PRK, photorefractive keratectomy; RGPCL, rigid gas-permeable contact lens; RLE, refractive lens exchange; SE, refractive spherical equivalent; TP, thinnest point in corneal pachymetry; VA, visual acuity. (Adapted from Güell et al . and Gore et al . )


BOX 30.1

Exclusion Criteria for Phakic Intraocular Lens Implantation in Patients With Keratoconus

AC, Anterior chamber; BSCVA, best spectacle-corrected visual acuity; ECC, endothelial cell count; ICL, implantable collamer lens.




  • 1.

    Progressive keratoconus


  • 2.

    BSCVA <20/50 and/or significant irregular astigmatism


  • 3.

    Significant corneal opacity


  • 4.

    ECC <2300 cells/mm 2


  • 5.

    Shallow AC depth (<3.00 mm for Artisan/Artiflex, <3.2 mm for ICL)


  • 6.

    Abnormal pupil function, or scotopic pupil >6.0 mm


  • 7.

    Anterior segment disease (e.g., herpetic keratitis, recurrent or chronic uveitis, cataract)


  • 8.

    Systemic disease that may increase risk of postoperative complications (atopy, diabetes mellitus, autoimmune disorder, connective tissue disease)




BOX 30.2

Clinical and Corneal Topo-tomographic Parameters Frequently Used to Determine Progression of Keratoconus ,




  • 1.

    Increase in mean keratometry ≥0.75 D


  • 2.

    Increase in SimK ≥1.00 D


  • 3.

    Change in manifest refractive spherical equivalent (RSE) ≥0.50 D


  • 4.

    Changes in manifest cylinder ≥ 1.00 D


  • 5.

    Decrease in corneal pachymetry ≥ 25 µm




In patients with stable, nonadvanced KC and with low CDVA and/or high irregular astigmatism, ICRS implantation should be considered before PIOL implantation. Although a number of tomographic indices allow quantification of irregular astigmatism, clinically significant irregular astigmatism is considered if CDVA with spectacles is ≤1 Snellen line worse than CDVA with rigid gas-permeable CL. ,


Combined Corneal Cross-Linking Plus Phakic Intraocular Lens Implantation


In progressive KC, PIOL implantation alone would not provide stable refractive results in the mid/long term. CXL is the only technique with proven effect on halting progression of KC. CXL can be combined with other treatments for visual rehabilitation, including sequential or simultaneous CXL + topography-guided PRK (Athens protocol), combined transepithelial phototherapeutic keratectomy + CXL, combined CXL + ICRS, and combined CXL + PIOL.


Combined CXL + PIOL implantation is a safe and effective strategy in eyes with progressive KC with moderate-high refractive error, regular astigmatism, and good CDVA, providing stabilization of the cone, as well as visual and refractive improvements comparable to those of non-KC eyes for up to 3 years after surgery ( Table 30.4 ). , However, there is still no consensus on the appropriate interval between CXL and PIOL implantation. The minimum interval between CXL and PIOL implantation should be individualized. In our experience, after a minimum of 3 months following CXL, we consider PIOL implantation once both manifest refraction and tomography scans are stable at two different time points at least 2 months apart ( Fig. 30.2 ). Both Izquierdo et al. and our group have found that combined CXL + iris-claw PIOL implantation significantly improved UDVA and CDVA, with high predictability of the refractive error in addition to a good safety profile. , Combined CXL + ICL implantation has shown similar outcomes in terms of effectiveness and safety in the long term. A recent study showed that the combined Athens protocol and PIOL implantation was also safe and effective.



TABLE 30.4

Reported Outcomes and Complications of Combined Corneal Cross-Linking and Phakic Intraocular Lens Implantation in Keratoconus




































































































































































































































































































Preoperative Data Post-CXL, Pre-PIOL Data
Author Publication (Year) Eyes (n) PIOL UDVA (logMAR) CDVA (logMAR) Sphere (D) Cylinder (D) RSE (D) K max /K min (D) ECC (cells/mm 2 ) CDVA RSE (D) Cylinder (D) K max /K min (D) ECC (cells/mm 2 ) Time Between CXL and PIOL (Months)
Izquierdo et al. 2011 11 Artiflex 1.40 ± 0.40 0.14 ± 0.06 −5.70 ± 1.21 −1.32 ± 0.86 −6.36 ± 1.09 48.20 ± 3.47 / 43.94 ± 2.92 2759.6 ± 159.8 1.16 ± 0.46 −5.90 ± 1.14 −1.30 ± 0.67 46.93 ±3.49 / 44.17 ± 1.64 2739.1 ± 157.0 6
Kymionis et al. 2011 1 Visian ICL CF 0.7 −10 −5 −12.5 63.51 / 57.24 N/R 0.5 −14.25 −4.5 61.72/57.17 N/R 12
Güell et al. 2012 17 Artiflex N/R 0.10 ± 0.09 −5.25 −3.54 ± 1.39 −6.99 ± 3.20 46.11 ± 1.17/43.29 ± 1.17 2847 0.10 ± 0.09 −6.93 ± 3.09 −3.51 ± 1.93 46.17 ± 1.26 /43.60 ± 1.26 2868 3.9 ± 0.7
Fadlallah et al. 2013 16 Visian ICL 1.67 ± 0.49 0.15 ± 0.06 −8.56 ± 3.90 2.64 ± 1.28 −7.24 ± 3.53 52.59 ± 4.79 / 46.00 ± 3.58 N/R 0.15 ± 0.06 −7.16 ± 3.58 2.45 ± 1.19 51.33 ± 4.41 / 46.02 ± 2.99 N/R 6
Shafik Shaheen et al. 2014 16 Visian ICL N/R 0.56 ± 0.13 (decimals) −6 ± 4.0 −5 ± 1.5 −8.5 ± 4.0 N/R 2850 N/R N/R N/R N/R N/R 12
Antonios et al. 2014 30 Visian ICL 1.57 ± 0.50 0.17 ± 0.08 −8.37 ± 3.89 2.95 ± 1.40 −6.96 ± 3.68 53.08 ± 5.17 / 46.52 ± 3.72 N/R 0.15 ± 0.06 −6.81 ± 3.48 2.74 ± 1.33 52.01 ± 4.87/46.23 ± 3.21 N/R 6
Doroodgar et al. 2017 40 Visian ICL 1.28 ± 0.37 N/R N/R N/R N/R N/R N/R 0.19 ± 0.11 −7.55 ± 4.22 −3.57 ± 1.56 N/R 2426.6 ± 107.6 ≥12
Emerah et al. 2019 14 Visian ICL 0.77 ± 0.20 0.18 ± 0.10 −3.7 ± 1.9 −2.3 ± 1.6 −4.48 ± 2.25 N/R N/R 71.4% of eyes had CXL before ICL implantation
Postoperative Data
Follow-Up (Months) UDVA (logMAR) CDVA (logMAR) Spherical Error (D) Cylinder (D) Final RSE (D) %RSE within ± 0.50 D %RSE within ± 1.00 D %eyes UDVA ≥ 20/40 %eyes gain ≥ 1 lines CDVA %eyes loss ≥ 2 lines CDVA %ECL Complications
6 0.16 ± 0.06 0.04 ± 0.05 −0.27 ± 0.52 −0.91 ± 0.61 −0.727 ± 0.66 45.5% 63.6% 100.0% 63.6% 0% 3.3% Mild haze (18.1%)
3 0.3 0.2 −0.25 −0.5 −0.5 100.0% 100.0% 100.0% 100.0% 0% N/R None reported
36.9 ± 15.0 0.17 ± 0.13 0.10 ± 0.09 0.06 ± 0.26 −0.62 ± 0.39 −0.22 ± 0.33 82.4% 94.1% 94.1% 30.0% 0.0% 0.1% Mild giant cell reaction (11.7%)
12 0.17 ± 0.06 0.12 ± 0.04 −1.47 ± 0.99 1.16 ± 0.64 −0.89 ± 0.76 75.0% 87.5% 81.0% N/R 0% N/R None reported
36 N/R 0.88 ± 0.18 (decimals) 0.00 ± 0.18 −0.05 ± 0.14 Final RSE < −0.25 100.0% 100.0% 81% had UDVA ≥ 20/25 N/R 0.0% 8.89% None reported
12 0.17 ± 0.06 0.11 ± 0.05 −1.36 ± 0.94 1.03 ± 0.60 −0.83 ± 0.76 N/R 63.3% 60% had UDVA ≥ 20/30 43.0% 0.0% N/R None reported
48 0.11 ± 0.13 −0.14 ± 0.13 N/R Mean change = 2.79 ± 1.78 Mean change = 7.44 ± 4.75 82.5% 97.1% 100.0% 82.5% 0.0% ≤5% None reported
6 0.15 ± 0.10 0.15 ± 0.10 −0.20 ± 0.50 −0.60 ± 0.50 Final RSE decreased 74% from preoperative 65% of eyes within ± 0.75 D 85.0% N/R 42.9% 0% N/R None reported

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Oct 30, 2022 | Posted by in OPHTHALMOLOGY | Comments Off on Phakic Intraocular Lenses

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