Journal List > J Korean Ophthalmol Soc > v.56(7) > 1010020

Seong, Choi, Choi, and Kim: Clinical Outcomes of Foldable Iris-Fixed Phakic Intraocular Lens and Change in Corneal Endothelial Cell Density

Abstract

Purpose:

To evaluate the efficacy, safety, stability and complications of the foldable iris-fixated phakic intraocular lens (Artiflex®, Ophtec BV, Groningen, Netherlands) implantation for the correction of myopia with astigmatism.

Methods:

The present study included 40 eyes of 20 patients who underwent Artiflex lens implantation, and 20 eyes of 10 patients who underwent Toric Artiflex lens implantation and were followed up for 1 year. We retrospectively examined visual acuity, re-fraction, any changes in astigmatism, efficacy, safety and corneal endothelial cell density. A correlation coefficient analysis of the factors that affected the changes was performed.

Results:

The mean preoperative refractive spherical equivalent was -9.18 ± 2.27 D and reached -0.45 ± 0.45 D at 1 year after surgery. Postoperatively, 99.9% of the eyes showed improved visual acuity of more than 0.8. In patients with Toric Artiflex lens implantation, the preoperative mean astigmatism was -2.67 ± 0.87 D, and at 1 year postoperatively -0.76 ± 0.40 D, showing a statistically significant decrease ( p < 0.001). The preoperative mean endothelial cell density was 2,850 ± 230 cells/mm2 and de-creased 1.3% on the final follow-up (2,812 ± 261 cells/mm2) but without statistical significance ( p = 0.456). Statistically significant correlation was not observed between endothelial cell loss and anterior chamber depth (r2 = -0.146, p = 0.267).

Conclusions:

Implantation of the iris-fixed intraocular lenses, Artiflex and Toric Artiflex, was safe and effective for correcting high myopia and astigmatism.

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Figure 1.
Efficacy. Postop = postoperation; UDVA = un-corrected distance visual acuity; Preop = preoperation; CDVA = corrected distance visual acuity.
jkos-56-1020f1.tif
Figure 2.
Preoperative and postoperative spherical equivalent.
jkos-56-1020f2.tif
Figure 3.
Stability: time course of manifest spherical equiv-alent after operation.
jkos-56-1020f3.tif
Figure 4.
Preoperative and postoperative refractive astigmatism.
jkos-56-1020f4.tif
Figure 5.
Postoperative changes in endothelial cell density.
jkos-56-1020f5.tif
Table 1.
Patient demographics
Characteristics Mean ± SD Range
Age (years) 28.6 ± 7.6 20 to 48
Gender (Female, %) 41 (68) -
ACD (mm) 3.25 ± 0.21 3.00 to 3.89
Spherical equivalent (D) -9.18 ± 2.27 -14.78 to -5.5
Cylinder (D) -2.68 ± 0.87 -1.50 to -4.50
Preoperative ECD (cells/mm2) 2,850 ± 230 2,165 to 3,352

Values are presented as mean ± SD unless otherwise indicated.

ACD = anterior chamber depth; ECD = endothelial cell density.

Toric Artiflex® inserted patient (20 eyes).

Table 2.
Preoperative and postoperative mean visual acuity, spherical equivalent and cylinder
Preoperative 3 months 6 months 1 year p-value
UCVA 0.71 ± 0.15 0.01 ± 0.03 0.01 ± 0.03 0.01 ± 0.03 <0.001
SE -9.18 ± 2.27 -0.64 ± 1.52 -0.52 ± 0.36 -0.45 ± 0.45 <0.001
Cylinder -2.67 ± 0.87 -1.01 ± 0.33 -0.81 ± 0.52 -0.76 ± 0.40 <0.001

Values are presented as mean ± SD.

UCVA = uncorrected visual acuity; SE = spherical equivalent.

log MAR.

Table 3.
Preoperative and postoperative coefficient of variation and percentage of hexagonal cells
Period Eyes (n) Mean ± SD p-value Mean ± SD p-value
CV CV change Hex cells (%) Hex cell change (%)
Preoperation 60 61.64 ± 20.54 NA NA 56.57 ± 10.84 NA NA
Postoperation
3 months 60 57.11 ± 22.36 -4.53 ± 23.08 0.134 57.60 ± 10.96 1.03 ± 10.50 0.142
6 months 60 56.93 ± 17.63 -4.71 ± 24.54 0.101 57.88 ± 10.91 1.32 ± 10.70 0.092
1 year 60 58.74 ± 32.39 -2.90 ± 26.58 0.402 58.17 ± 12.00 1.60 ± 10.73 0.108

Values are presented as mean ± SD unless otherwise indicated.

CV = coefficient of variation; Hex = hexagonal; NA = not applicable.

Paired t-test between post and preoperative measurements.

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