Toric Implantable Collamer Lens for the Treatment of Myopic Astigmatism

Figures & data

Table 1 Preoperative Baseline Characteristics

Demographics	Mean ±SD (Range) | % (n)
Patients (n)	55
Age (years)	33 ± 8.25 (18–54)
Male/Female	38.2% (21)/61.8% (34)
Unilateral/Bilateral Implantation	14.6% (14)/85.4% (41)
Parameter	Mean ± SD (range) | % eyes (n)
Eyes (n)	96
OD/OS	51.0% (49)/49.0% (47)
UDVA*	1.77 ± 0.13 (1.18 to 1.80)
CDVA*	0.02 ± 0.07 (−0.13 to 0.48)
MRSE (D)	−10.31 ± 3.10 (−21.75 to −4.88)
Refracted Sphere (D)	−8.98 ± 3.04 (−20.0 to −2.75)
Refracted Cylinder (D)	−2.67 ± 1.02 (−5.75 to −1.00)
Axial length (mm)	26.74 ± 1.51 (24.09 to 31.61)
Aqueous Depth (mm)	3.78 ± 0.29 (2.96 to 4.49)
White-to-White (mm)	11.99 ± 0.41 (11.12 to 13.14)
Lenticular Rise (mm)	0.64 ± 0.15 (0.37 to 1.01)
Sulcus-to-Sulcus (mm)	11.61 ± 0.49 (10.39 to 12.73)
Corneal thickness (μm)	519.16 ± 34.05 (448 to 588)
Anterior chamber angle, Nasal	43.81 ± 6.45 (30.70 to 62.70)
Anterior chamber angle, Temporal	44.02 ± 7.69 (31.50 to 67.80)

Note: *Visual acuity reported as LogMAR.

Abbreviations: UDVA, uncorrected distance visual acuity; CDVA, corrected distance visual acuity; MRSE, manifest refraction spherical equivalent; D, diopters.

Table 2 Pre and Postoperative Visual Outcomes at Postoperative Time Points

Parameters	Pre-Operative	POD 1	1 wk	1 mo	3 mo	6 mo	12 mo
Number of eyes (patients)	96 (55)	96 (55)	93 (53)	85 (49)	75 (44)	46 (26)	46 (27)
UDVA*	1.77 ± 0.13 (1.18 to 1.80)	0.11 ± 0.22 (−0.15 to 1.30)	0.22 ± 0.28 (0.10 to 1.18)	0.31 ± 0.38 (0.00 to 1.18)	0.23 ± 0.36 (0.10 to 1.18)	0.10 ± 0.00 (0.10 to 0.10)	0.10 ± 0.00 (0.10 to 0.10)
CDVA*	0.02 ± 0.07 (−0.13 to 0.48)	0.14 ± 0.21 (−0.13 to 0.40)	0.01 ± 0.05 (−0.13 to 0.10)	0.10 ± 0.00 (0.10 to 0.10)	0.10 ± 0.00 (0.10 to 0.10)	0.10 ± 0.00 (0.10 to 0.10)	0.10 ± 0.00 (0.10 to 0.10)
MRSE (D)	−10.31 ± 3.10 (−21.75 to −4.88)	−2.75 ± 2.68 (−6.50 to +0.38)	−0.12 ± 0.47 (−2.00 to +0.63)	−0.24 ± 1.09 (−6.75 to +2.50)	−0.33 ± 1.12 (−6.75 to +2.00)	−0.13 ± 0.54 (−1.50 to +1.75)	−0.23 ± 0.47 (−1.25 to 1.50)
Refractive Sphere (D)	−8.98 ± 3.04 (−20.00 to −2.75)	−2.36 ± 2.83 (−6.50 to +0.75)	+0.24 ± 0.40 (−0.75 to +1.00)	+0.10 ± 1.06 (−6.25 to +3.00)	+0.01 ± 1.14 (−6.25 to +2.50)	+0.28 ± 0.64 (−0.75 to +3.00)	+0.14 ± 0.60 (−1.00 to +3.00)
Refractive Cylinder (D)	−2.67 ± 1.02 (−5.75 to −1.50)	−0.79 ± 0.68 (−1.75 to 0.00)	+0.24 ± 0.40 (−1.75 to 0.00)	−0.68 ± 0.43 (−2.25 to 0.00)	−0.68 ± 0.38 (−1.50 to 0.00)	−0.82 ± 0.52 (−2.50 to 0.00)	−0.73 ± 0.51 (−3.00 to −0.25)

Notes: *Visual acuity reported as LogMAR. Values reported as mean ± SD (range).

Abbreviations: UDVA, uncorrected distance visual acuity; CDVA, corrected distance visual acuity; MRSE, manifest refraction spherical equivalent.

Table 3 Implant Characteristics

Parameter	Median (Range) | % Eyes (n)
Size (mm)
12.1	4.2% (4)
12.6	65.6% (63)
13.2	30.2% (29)
13.7	0% (0)
MRSE (D)	−10.50 (−5.75 to −15.00)
Refractive Sphere (D)	−12.00 (−6.50 to −16.00)
Refractive Cylinder (D)	2.50 (+1.00 to +4.00)

Abbreviations: MRSE, manifest refraction spherical equivalent; D, diopters.

Figure 1 Standard reporting of visual and refractive outcomes for eyes at three and twelve months following Toric ICL implantation. (A) Cumulative preoperative CDVA and postoperative UDVA; (B) difference between postoperative UDVA and CDVA; (C) change in CDVA; (D) attempted versus achieved MRSE; (E) accuracy of MRSE; (F) stability of MRSE over time.

Abbreviations: UDVA, uncorrected distance visual acuity; CDVA, corrected distance visual acuity; MRSE, manifest refraction spherical equivalent; D, diopter.

Figure 2 Outcomes of refractive astigmatism for eyes at three and twelve months following Toric ICL implantation. (A) Change in magnitude of refractive astigmatism pre- versus postoperatively. (B) Magnitude of TIA versus SIA. (C) Postoperative angle of error.

Abbreviations: TIA, target induced astigmatism; SIA, surgically induced astigmatism; D, diopters.

Figure 3 Preoperative and three month postoperative refractive astigmatism (n=65, D diopters).

Figure 4 Preoperative and twelve month postoperative refractive astigmatism (n=40, D diopters).

Figure 5 Mean subjective vault over postoperative time.

Figure 6 Mean measured IOP preoperatively and over postoperative time.

Figure 7 Percentage of eyes with reported dryness at postoperative follow-up (n = number of symptomatic eyes over eyes at follow-up).

Figure 8 Percentage of patients with reported glare/halos at postoperative follow-up (n = number of symptomatic eyes over eyes at follow-up).

Table 4 Toric ICL Outcomes Compared Between the Present Study and the Literature

Study	Year	Eyes	Time	MRSE ± SD (Range) D	Abs MRC* ± SD Range) D	UDVA 20/20 or Better (%)	% MRSE/MRC ± 0.50 D Intended	% MRSE/MRC ±1.00 D Intended	Safety Index	Efficacy Index
Present study	2021	96	Preop	−10.31 ± 3.10 (−4.88 to −21.75)	2.67 ± 1.02 (1.50 to 5.75)	–	–	–	–	–
		75	3 mo	−0.33 ± 1.12 (−6.75 to +2.00)	0.68 ± 0.38 (0.00 to 1.50)	62	77/44	95/89	1.14	0.92
		46	12 mo	−0.23 ± 0.47 (−1.25 to 1.50)	0.73 ± 0.51 (0.25 to 3.00)	74	79/49	93/86	1.10	0.98
FDA Clinical Endpoints^Citation8	2018	–	–	–	–	–	50/40	75/65	–	–
FDA Clinical Trial^Citation8	2018	210	Preop	−9.37 ± 2.67 (−2.38 to −19.50)	1.95 ± 0.84 (1.00 to 4.00)	–	–	–	–	–
		191	3 mo	0.13 ± 0.39 (−1.25 to +1.25)	0.52 ± 0.49 (0.00 to 3.00)	–	–	–	–	–
		194	12 mo	0.03 ± 0.46 (−2.25 to +1.00)	0.52 ± 0.48 (0.00 to 3.00)	81.9	76.9/69.1	97.4/92.3	–	–
Sanders et al^Citation5	2007	200	Preop	−9.36 ± 2.66	1.93 ± 0.84	–	–	–	–	–
		175	6 mo	–	–	–	71.3/53.4	97.1/86.2	–	–
		186	12 mo	0.05 ± 0.46	0.51 ± 0.48	83.1	76.9/48.4	97.3/85.5	–	–
Hyun et al^Citation14	2017	24	Preop	−10.68 ± 2.44 (−5.57 to −15.68)	2.50 ± 1.24 (1.00 to 5.25)	–	–	–	–	–
			Postop	−0.41 ± 0.48 (−1.50 to 0.56)	0.63 ± 0.33 (0.00 to 1.25)	62.5	–	–	1.14	1.06
Kamiya et al^Citation6	2013	50	Preop	−9.47 ± 2.91 (−3.00 to −17.25)	2.23 ± 1.09 (0.75 to 6.50)	–	–	–	–	–
			3 mo	0.05 ± 0.22	0.50 ± 0.43	94	–	–	1.21	1.02
			12 mo	−0.11 ± 0.32	0.57 ± 0.60	90	–	–	1.23	1.03
			36 mo	−0.22 ± 0.37	0.49 ± 0.41	86	82/92	98/94	1.16	0.94
Sheng et al^Citation30	2012	54	Preop	−12.08 ± 4.22 (−6.00 to −24.75)	1.88 ± 1.49 (1.00 to 5.50)	–	–	–	–	–
			8 mo	−0.41 ± 0.61	0.41 ± 0.61	72.2%	–	–	–	–

Note: *MRC reported as absolute magnitude for comparison across studies.

Abbreviations: UDVA, uncorrected distance visual acuity; MRSE, manifest refraction spherical equivalent; D, diopter; MRC, manifest refractive cylinder.

Table 5 Comparison of Toric ICL Complications and Astigmatism Outcomes Between Present Study and Literature

Study	Year	Remove (# Eyes)	Replace (# Eyes)	Reposition (# Eyes)	Observed Rotation	TIA ± SD (Range) D	SIA ± SD (Range) D
Present	2021	0	0	2	≤ 5°: 87% 5–15°: 11% >15°: 2%	2.16 ± 0.86	1.75 ± 0.85
FDA Clinical Trial^Citation8	2018	3	1	1	≤ 5°: 94.3% ≤ 10°: 97.9%	–	–
Sanders et al^Citation5	2007	3	1	1	≤ 5°: 86.9% ≤ 10°: 92.3%	–	–
Hyun et al^Citation14	2017	–	–	–	≤ 5°: 70.8%	2.31 ± 1.24 (1.00 to 5.22)	2.11 ± 1.09 (0.75 to 4.50)

Abbreviations: TIA, target induced astigmatism; SIA, surgically induced astigmatism.

Visian® Toric ICL (Implantable Collamer® Lens) – P030016/S001 | FDA. Available from: https://www.fda.gov/medical-devices/recently-approved-devices/visianr-toric-icl-implantable-collamerr-lens-p030016s001. Accessed May 12, 2021

 Google Scholar

Sanders DR, Schneider D, Martin R, et al. Toric implantable collamer lens for moderate to high myopic astigmatism. Ophthalmology. 2007;114(1):54–61. doi:10.1016/j.ophtha.2006.08.049

 PubMed Web of Science ®Google Scholar

Hyun J, Lim DH, Eo DR, Hwang S, Chung ES, Chung TY. A comparison of visual outcome and rotational stability of two types of toric implantable collamer lenses (TICL): V4 versus V4c. PLoS One. 2017;12(8). doi:10.1371/journal.pone.0183335

 Web of Science ®Google Scholar

Kamiya K, Shimizu K, Kobashi H, Igarashi A, Komatsu M. Three-year follow-up of posterior chamber toric phakic intraocular lens implantation for moderate to high myopic astigmatism. PLoS One. 2013;8(2). doi:10.1371/journal.pone.0056453

 Web of Science ®Google Scholar

Sheng XL, Rong WN, Jia Q, et al. Outcomes and possible risk factors associated with axis alignment and rotational stability after implantation of the Toric implantable collamer lens for high myopic astigmatism. Int J Ophthalmol. 2012;5(4):459–465. doi:10.3980/j.issn.2222-3959.2012.04.10

 PubMed Web of Science ®Google Scholar