Clinical Outcomes of Foldable Iris-Fixed Phakic Intraocular Lens and Change in Corneal Endothelial Cell Density

San Seong; Chul Myung Choi; Tae Hoon Choi; Se Kyung Kim

doi:10.3341/jkos.2015.56.7.1020

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

Original Article

J Korean Ophthalmol Soc 2015;56(7):1020-1027.

Published online: 27 August 2015

DOI: https://doi.org/10.3341/jkos.2015.56.7.1020

Clinical Outcomes of Foldable Iris-Fixed Phakic Intraocular Lens and Change in Corneal Endothelial Cell Density

San Seong, M.D, Chul Myung Choi, M.D, PhD, Tae Hoon Choi, M.D, PhD, Se Kyung Kim, M.D

Nune Eye Hospital, Seoul, Korea

Address reprint requests to Se Kyung Kim, MD Nune Eye Hospital, #404 Seolleung-ro, Gangnam-gu, Seoul 135-841, Korea Tel: 82-2-1661-1175, Fax: 82-2-2086-1175 E-mail: sekyungkim@naver.com

* This study was presented as an e-poster at the 112th Annual Meeting of the Korean Ophthalmological Society 2014.

Received 17 October 201411 March 2015 Accepted 4 June 2015

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: Artiflex, Foldable, Intraocular lens, Iris-fixed, Toric artiflex

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Figure 1.

Efficacy. Postop = postoperation; UDVA = un-corrected distance visual acuity; Preop = preoperation; CDVA = corrected distance visual acuity.

Figure 2.

Preoperative and postoperative spherical equivalent.

Figure 3.

Stability: time course of manifest spherical equiv-alent after operation.

Figure 4.

Preoperative and postoperative refractive astigmatism.

Figure 5.

Postoperative changes in endothelial cell density.

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^∗
Period	Eyes (n)	CV	CV change	p-value^∗	Hex cells (%)	Hex cell change (%)	p-value^∗
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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