Clinical Outcomes of Toric Implantable Collamer Lens implantation

Jae Moon Yoon; Sang Jung Moon; Kyung Hun Lee

doi:10.3341/jkos.2009.50.6.839

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Yoon, Moon, and Lee: Clinical Outcomes of Toric Implantable Collamer Lens implantation

Original Article

J Korean Ophthalmol Soc 2009;50(6):839-851.

Published online: 7 September 2009

DOI: https://doi.org/10.3341/jkos.2009.50.6.839

Clinical Outcomes of Toric Implantable Collamer Lens implantation

Jae Moon Yoon, MD, Sang Jung Moon, MD, Kyung Hun Lee, MD

Department of Ophthalmology, Sungmo Eye Hospital, Busan, Korea

Address reprint requests to Kyung Hun Lee, MD Department of Ophthalmology, Sungmo Eye Hospital #1078-7, Woo 2-dong, Haeundae-gu, Busan 612-823, Korea Tel: 82-51-743-0775, Fax: 82-51-743-0776, E-mail: sungmo@sungmo.co.kr

Received 20 March 2008 Accepted 25 March 2009

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 assess the efficacy of the Toric Implantable Collamer Lens (Toric ICL) to treat moderate to high myopic astigmatism.

Methods

Toric ICL was implanted in 77 eyes of 40 patients with myopia (spherical equivalent [SE] between 3.5 and 18.5 diopters [D]) and astigmatism between 1 and 6 D. The patients were followed up for at least 3 months. Uncorrected visual acuity (UCVA), refraction, best spectacle-corrected visual acuity (BSCVA), adverse events, and postoperative complications were evaluated.

Results

At 3months postoperatively, the proportion of eyes with 1.0 or better UCVA (56 eyes out of 77 eyes, 72.7%) was significantly greater than the proportion of eyes with preoperative 1.0 or better BSCVA (38 eyes out of 77 eyes, 49.4%). The mean manifest refractive cylinder dropped from 2.78D (±1.05) at baseline to 0.35D (±0.34) postoperatively, an 87.4% decrease in astigmatism. Mean manifest refraction SE (MRSE) improved from −9.93D (±2.66) preoperatively to 0.15D (±0.33) postoperatively. A total of 96.1% of eyes were predicted accurately to within ±0.75D of predicted MRSE. Mean improvement in BSCVA was 0.79lines; there were no eyes that lost two lines of BSCVA after 3 months postoperatively.

Conclusions

The results support the efficacy and predictability of Toric ICL implantation to treat moderate to high myopic astigmatism.

Keywords: Myopic astigmatism, Toric ICL, Toric Implantable Collamer Lens

References

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Figure 1.

Preoperative (pre-op) best spectacle-corrected visual acuity (BSCVA) versus 3-month postoperative uncorrected visual acuity (UCVA) for the Toric Implantable Collamer Lens cohort.

Figure 2.

Preoperative (pre-op) versus 3-month post-operative refractive cylinder for the Toric Implantable Collamer Lens cohort (D=diopters; MR=manifest refraction).

Figure 3.

Attempted vs achieved spherical equivalent The difference between achieved spherical equivalent and attempted spherical equivalent is within 1diopter in most cases.

Figure 4.

(A) Preoperative astigmatism. The yellow dots show preoperative astigmatism which consist of axis and diopter in the double angle scatter plot. It is scattered and the average of astigmatism is −2.75 diopter with 30.9° (B) 3-month postoperative astigmatism The yellow dots show postoperative astigmatism which consists of axis and diopter in the double angle scatter plot. It is not scattered but focused on zero point and the average of astigmatism is −0.35 diopter with 24.9°

Figure 5.

The amount of corrected astigmatism in each patient. In most of the patients, astigmatism decreased by about 86%.

Figure 6.

Spherical equivalent (MRSE=manifest refraction spherical equivalent).

Figure 7.

Best spectacle corrected visual acuity.

Figure 8.

Preoperative (pre-op) versus 3-month post-operative best spectacle-corrected visual acuity (BSCVA) for the Toric Implantable Collamer Lens cohort.

Figure 9.

BSCVA line changes Preoperative versus 3-month postoperative line change in best spectacle-corrected visual acuity (BSCVA) for the Toric Implantable Collamer Lens cohort.

Figure 10.

Scheimpflug photographs shows rotation of ICL. (A) First attack of rotation, postoperative 130 days. The rotation is about 45° clockwise from the initial position. (B) Second attack of rotation, postoperative 60 days after correction. The rotation is about the same as in the first attack.

Figure 11.

Time sequence displacement of Toric ICL during surgical procedure that have rotational problem after surgery. (A) Axis alignment. (B) 5°clockwise rotation from the axis marker. (C) Correction of the misalignment by Vukich ICL manipulator during surgery. (D) At the end of the surgery, there was still 5° clockwise tilting even after repeated axis alignment.

Figure 12.

Four forms of vaulting as visualized with the Scheimpflug camera. (A) No central vaulting and no peripheral vaulting. (B) Low central vaulting and no peripheral vaulting. (C) Moderate central vaulting and partial/asymmetrical peripheral vaulting. (D) Marked central vaulting and complete peripheral vaulting.

Table 1.

Manifest refraction cylinder, the toric implan-table collamer lens

Cylinder	Preoperative <n(%)>	3 months <n(%)>
≤ 0.25D^*	0 (0)	55 (71)
≤ 0.50D	0 (0)	63 (82)
≤ 1.00D	2 (2)	74 (96)
≤ 1.50D	9 (12)	77 (100)
≤ 2.00D	23 (30)	77 (100)
≤ 3.00D	57 (74)	77 (100)
≤ 4.00D	65 (84)	77 (100)
≤ 5.00D	76 (99)	77 (100)
≤ 6.00D	77 (100)	77 (100)
Mean	−2.78D	−0.35D
SD^†	1.05	0.34
Range	−1D to-6D	0D to-1.25D
Total	77	77

^* D=diopters

^† SD=standard deviatiation.

Table 2.

Predictability of manifest refraction spherical equivalent, attempted versus achieved

	1 day <n(%)>	1 week <n(%)>	1 month <n(%)>	3 months <n(%)>
≤0.25D^*	24 (31.2)	30 (39.0)	33 (42.9)	31 (40.3)
≤0.5D	49 (63.6)	58 (75.3)	59 (76.6)	64 (83.1)
≤0.75D	64 (83.1)	73 (94.8)	73 (94.8)	74 (96.1)
≤1.0D	73 (94.8)	75 (97.4)	75 (97.4)	75 (97.4)
≤1.5D	75 (97.4)	77 (100)	77 (100)	77 (100)
≤2.0D	77 (100)	77 (100)	77 (100)	77 (100)
Overcorrected>1D	3 (3.9)	2 (2.6)	2 (2.6)	2 (2.6)
Undercorrected>1D	1 (1.3)	0 (0)	0 (0)	0 (0)
Total	77	77	77	77

^* D=diopters.

Table 3.

Accuracy of cylinder to target, the visian toric implantable collamer lens

Cylinder	1 week (n=77)	3 months (n=77)
Attempted change± SD^*	2.78±1.05	2.78±1.05
Achieved change± SD	2.39±0.97	2.43±1.00
% achieved within±0.5D of attempted	6/77 (79.2)	63/77 (81.8)
% achieved within±1.0D of attempted	72/77 (93.5)	74/77 (96.1)

^* D = diopters.

Table 4.

The amount of corrected astigmatism in each patient

Patient number	Preop astigmatism (D)	Postop astigmatism at 3 months (D)	Amount of corrected astigmatism (%)
1	−5	0	100.0
2	−4.5	0	100.0
3	−4.5	0	100.0
4	−3.25	0	100.0
5	−3	0	100.0
6	−3	0	100.0
7	−3	0	100.0
8	−2.75	0	100.0
9	−2.75	0	100.0
10	−2.5	0	100.0
11	−2.5	0	100.0
12	−2.5	0	100.0
13	−2.25	0	100.0
14	−2.25	0	100.0
15	−2.25	0	100.0
16	−2.25	0	100.0
17	−2	0	100.0
18	−2	0	100.0
19	−1.5	0	100.0
20	−4.75	−0.25	94.7
21	−4.5	−0.25	94.4
22	−3.25	−0.25	92.3
23	−3.25	−0.25	92.3
24	−3	−0.25	91.7
25	−3	−0.25	91.7
26	−3	−0.25	91.7
27	−3	−0.25	91.7
28	−3	−0.25	91.7
29	−2.75	−0.25	90.9
30	−2.5	−0.25	90.0
31	−2.5	−0.25	90.0
32	−2.5	−0.25	90.0
33	−2.5	−0.25	90.0
34	−2.5	−0.25	90.0
35	−2.5	−0.25	90.0
36	−2.5	−0.25	90.0
37	−4.75	−0.5	89.5
38	−4.5	−0.5	88.9
39	−2.25	−0.25	88.9
40	−2.25	−0.25	88.9
41	−2	−0.25	87.5
42	−2	−0.25	87.5
43	−2	−0.25	87.5
44	−2	−0.25	87.5
45	−2	−0.25	87.5
46	−2	−0.25	87.5
47	−2	−0.25	87.5
48	−3.75	−0.5	86.7
49	−1.75	−0.25	85.7
50	−1.75	−0.25	85.7
51	−1.75	−0.25	85.7
52	−1.75	−0.25	85.7
53	−3.25	−0.5	84.6
54	−3	−0.5	83.3
55	−1.5	−0.25	83.3
56	−1.5	−0.25	83.3
57	−1.5	−0.25	83.3
58	−1.5	−0.25	83.3
59	−1.5	−0.25	83.3
60	−1.5	−0.25	83.3
61	−4.25	−0.75	82.4
62	−5	−1	80.0
63	−2.5	−0.5	80.0
64	−2.5	−0.5	80.0
65	−2.5	−0.5	80.0
66	−6	−1.25	79.2
67	−4.5	−1	77.8
68	−4.5	−1	77.8
69	−4	−1	75.0
70	−3	−0.75	75.0
71	−3.5	−1	71.4
72	−3.5	−1	71.4
73	−3	−1	66.7
74	−2	−0.75	62.5
75	−2.75	−1.25	54.5
76	−1	−0.75	25.0
77	−1	−1.25	−25.0
Total	−2.78	−0.35	86.14

Table 5.!

The relation between axis misalignment and vault

		Axis misalignment				Total
			<5°	5°∼10°	≥10°	
Vault		V1	3	0	0	3
		V2	53	2	1	56
		V3	12	1	2	15
		V4	2	1	0	3
	Total		70	4	3	77

Pearson chi-square test p=0.130 (p>0.05).

Table 6.

Summary of key efficacy variables, the Toric Implantable Collamer Lens (ICL) vs. Spherical ICL

	Visian Toric ICL, 3 months postoperatively in Korea^§	Visian Toric ICL, 12 months postoperatively in U.S.	Spherical ICL, 3 months postoperatively in Korea^Π	Spherical ICL, 12 months postoperatively in U.S.	U.S. FDA targets
UCVA^*					
1.0 better	72.7%	83.1%	38.6%	50.4%	
0.5 better	96.1%	95.6%	61.4%	91.0%	85%(75%)^#
Predictability (MRSE^†)					
Attempted vs. achieved					
±0.50D^‡	83.1%	76.9%	81.9%	67.5%	50%(30%)^#
±1.00D	97.4%	97.3%	97.6%	88.2%	75%(60%)^#
±2.00D	100%	100%	100%	98.1%	

^* UCVA=uncorrected visual acuity

^† MRSE=manifest refraction spherical equivalent

^‡ D=diopter

^§ This study

^Π Chun et al⁹ study

^# (for laser refractive surgery>7D of myopia).

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