Clinical Outcomes of Plate-Haptic Diffractive Multifocal Toric IOL in Cataract Eyes with Long Axial Length and Corneal Astigmatism

doi:10.21203/rs.3.rs-4705686/v1

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Clinical Outcomes of Plate-Haptic Diffractive Multifocal Toric IOL in Cataract Eyes with Long Axial Length and Corneal Astigmatism

https://doi.org/10.21203/rs.3.rs-4705686/v1

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The prospective study is aimed to determine the clinical outcomes of plate-haptic diffractive multifocal toric intraocular lens (IOL) implantation in cataract patients with long axial length and corneal astigmatism. Visual outcomes, defocus curves, contrast sensitivity, rotational stability, vector changes of refractive astigmatism and patient satisfaction were assessed over 3 months. Vector analysis was performed by the Alpins method. A total of 36 eyes (18 patients) underwent cataract surgery with implantation of AT LISA toric 909M multifocal toric IOL. Postoperatively, mean refractive sphere and cylinder were reduced to 0.13 ± 0.23 and − 0.29 ± 0.32 diopter (D), respectively. Mean uncorrected distance and near visual acuities (logMAR) were 0.40 ± 0.10 and 0.19 ± 0.16, respectively. At 3 months, 91.7% of patients showed IOL rotation of less than 5 degrees. The difference vector was 0.34 ± 0.26 D, for a correction index of 0.93 ± 0.40 at 3 months. In summary, plate-haptic diffractive multifocal toric IOL improves distance and near visual functions and reduces refractive astigmatism in cataract patients with long axial length and corneal astigmatism.

Health sciences/Medical research/Study design/Clinical trials

Health sciences/Diseases/Eye diseases/Lens diseases

Multifocal toric IOL

Cataract surgery

Long axial length

Corneal astigmatism

Excessive growth of axial length results from anterior chamber depth, lens thickness, and vitreous chamber depth increases.¹ Long axial length generally correlates with high myopia, which accelerates cataract progression.^2,3 Besides, more than 30% cataract patients have corneal astigmatism over 1.0 diopter (D). Astigmatism correction is critical for ideal visual function.^4,5 Thus, in cataract patients with long axial length, refractive corrections of sphere and cylinder errors are essential for postsurgical visual outcomes.

Nowadays, cataract cases usually seek total visual rehabilitation and full independence from spectacles.⁶ Implantation of monofocal intraocular lens (IOL) causes the loss of accommodation, with the patients able to see clearly only at a certain distance. However, multifocal IOL is a useful option to widen the distance of clear vision, which can simultaneously correct ametropia and address presbyopia.^6–8 Combining the needs for astigmatism correction, diffractive multifocal toric IOL is designed to simultaneously compensate for corneal astigmatism and allow accommodation after cataract surgery.^9,10 In addition, the plate-haptic design allows the IOL to be tightly held in the capsular bag through 4 corners, which proves to be more stable in larger capsular bags in patients with long axial length.^11,12

The purpose of the current study was to assess visual outcomes and astigmatic changes after cataract surgery with the implantation of plate-haptic diffractive multifocal toric IOL in cataract patients with long axial length and corneal astigmatism. The clinical results of plate-haptic diffractive multifocal toric IOL for the treatment of cataract with long axial length and refractive astigmatism correction were obtained by a comprehensive analysis.

Demographic

The study enrolled 36 eyes of 18 patients (8 females and 10 males). The mean patient age was 62.7 ± 12.7 years (range 45.0 to 85.0 years). Preoperatively, mean axial length (AL) was 27.31 ± 2.20 mm (range 25.03 to 34.21 mm, Table 1). Mean anterior chamber depth (ACD) was 3.40 ± 0.32 mm (range 2.86 to 4.09 mm, Table 1). Mean angle Kappa was 0.27 ± 0.11 mm (rang 0.06 to 0.50 mm, Table 1). The root mean square of corneal high-order aberration for 4-mm diameter (HOA RMS) was 0.18 ± 0.08 mm (rang 0.00 to 0.38 mm, Table 1). True corneal astigmatism (ΔTK) for corneal astigmatism was − 1.75 ± 0.77 D (rang − 0.80 to -3.73 D, Table 1). The mean spherical power of the IOL was 8.97 ± 5.68 D (rang − 6.00 to 18.00 D, Table 1), and mean cylindrical power was 1.98 ± 0.91 D (rang 1.00 to 4.00 D, Table 1). Mean pupil diameter (PD) values were 2.88 ± 0.50 mm under the photopic condition and 4.41 ± 0.42 mm under the mesopic condition.

Table 1

Demographic information of cataract patients.
	Mean	±	SD	Median	Range
AL(mm)	27.31	±	2.20	26.76	25.03	,	34.21
ACD(mm)	3.40	±	0.32	3.42	2.86	,	4.09
LT(mm)	4.34	±	0.34	4.43	3.32	,	4.83
WTW(mm)	11.99	±	0.37	12.00	11.40	,	12.80
Angel Kappa (mm)	0.27	±	0.11	0.25	0.06	,	0.50
HOA RMS (mm)	0.18	±	0.08	0.17	0.00	,	0.38
TK1(D)	42.53	±	1.43	42.42	39.19	,	45.42
TK2(D)	44.27	±	1.22	44.41	42.20	,	46.46
Mean TK(D)	43.40	±	1.27	43.36	41.06	,	45.94
ΔTK(D)	-1.75	±	0.77	-1.51	-0.80	,	-3.73
IOL sphere (D)	8.97	±	5.68	9.25	-6.00	,	16.00
IOL cylinder (D)	1.98	±	0.91	2.00	1.00	,	4.00
AL, axial length; ACD, anterior chamber depth; LT, lens thickness; WTW, white-to-white distance; HOA RMS, root mean square of corneal high order aberration for 4-mm diameter; TK1, true keratometry of flat meridian; TK2, true keratometry of steep meridian; ΔTK, true corneal astigmatism; IOL sphere, sphere power of intraocular lens; IOL cylinder, cylinder power of intraocular lens.

Visual Outcomes

Table 2 showed the obtained visual and refractive results. Compared with preoperative manifest sphere (-6.66 ± 5.37 D, range − 18.00 to 1.75 D), manifest sphere at 1 day after surgery (0.11 ± 0.43 D, range − 0.75 to 2.00 D) showed a significant reduction (P < 0.05, Wilcoxon test). At 1 month, the manifest sphere (0.17 ± 0.29 D, range − 0.25 to 0.39 D) showed a modest shift (P < 0.05, Wilcoxon test). Compared with preoperative mean refractive cylinder (-1.88 ± 1.11 D, range − 4.00 to 0.00 D), mean refractive cylinder was significantly reduced 1 day (-0.26 ± 0.36 D, range − 1.00 to 0.00 D) after surgery (P < 0.05, Wilcoxon test). At 1 month, mean refractive cylinder (-0.31 ± 0.39 D, range − 1.50 to 0.00 D) showed a modest shift (P < 0.05, Wilcoxon test). Manifest sphere (0.13 ± 0.23 D, range − 0.25 to 0.75 D) and mean refractive cylinder (-0.29 ± 0.32 D, range − 1.00 to 0.00 D) had no significant changes at 3-month follow-up.

Table 2

Visual acuity (logMAR) and refraction data during follow-up.
		Pre-operation			Post-operation
		Pre-operation			1 D			1W			1M			3M
Sphere	Mean ± SD	-6.66	±	5.37	0.11	±	0.43*	0.06	±	0.22	0.17	±	0.29*	0.13	±	0.23
(D)	Median	-6.88			0.00			0.00			0.00			0.00
	Range	-18.00	,	1.75	-0.75	,	2.00	-0.25	,	1.00	-0.25	,	1.00	-0.25	,	0.75
Cylinder	Mean ± SD	-1.88	±	1.11	-0.26	±	0.36*	-0.15	±	0.29	-0.31	±	0.39*	-0.29	±	0.32
(D)	Median	-2.13			0.00			0.00			0.00			-0.13
	Range	-4.00	,	0.00	-1.00	,	0.00	-0.75	,	0.50	-1.50	,	0.00	-1.00	,	0.00
CDVA	Mean ± SD	0.36	±	0.24	0.06	±	0.10*	0.03	±	0.09	0.01	±	0.12*	-0.01	±	0.10
(LogMAR)	Median	0.30			0.02			0.00			0.00			0.00
	Range	0.05	,	1.00	-0.08	,	0.30	-0.18	,	0.22	-0.18	,	0.30	-0.18	,	0.22
UDVA	Mean ± SD		-		0.09	±	0.12	0.07	±	0.12	0.07	±	0.13	0.04	±	0.10*
(LogMAR)	Median				0.10			0.05			0.05			0.05
	Range				-0.08	,	0.52	-0.08	,	0.40	-0.18	,	0.40	-0.18	,	0.22
UIVA	Mean ± SD		-		0.21	±	0.12	0.19	±	0.12	0.21	±	0.11	0.22	±	0.14
(LogMAR)	Median				0.20			0.20			0.20			0.20
	Range				0.00	,	0.49	0.00	,	0.49	0.00	,	0.60	0.00		0.60
UNVA	Mean ± SD		-		0.20	±	0.14	0.22	±	0.14	0.15	±	0.16*	0.19	±	0.16*
(LogMAR)	Median				0.20			0.20			0.10			0.20
	Range				-0.08	,	0.40	0.00	,	0.60	-0.08	,	0.40	-0.08	,	0.70
CDVA, corrected distance visual acuity; UDVA, uncorrected distance visual acuity; UIVA, uncorrected intermediate visual acuity; UNVA, uncorrected near visual acuity.
1D, 1 day; 1W, 1 week after surgery; 1M, 1 month after surgery; 3M, 3 months after surgery.
*, P < 0.05, Wilcoxon test.

As for corrected distance visual acuity (CDVA), a significant improvement was found 1 day (0.06 ± 0.10, range − 0.08 to 0.30) after surgery (P < 0.05, Wilcoxon test). At 1 month, CDVA (0.01 ± 0.12, range − 0.18 to 0.30) was further improved (P < 0.05, Wilcoxon test). Uncorrected distance visual acuity (UDVA) showed significant improvement (0.04 ± 0.10, range − 0.18 to 0.22) at 3 months (P < 0.05, Wilcoxon test). Uncorrected intermediate visual acuity (UIVA) was stable after surgery with no significant changes during the remaining follow-up period. At 1 month, uncorrected near visual acuity (UNVA) was 0.15 ± 0.16 (range − 0.08 to 0.40) with a significant improvement (P < 0.05, Wilcoxon test). However, UNVA showed a modest reduction (0.19 ± 0.16, range 0.08 to 0.70) at 3 months (P < 0.05, Wilcoxon test).

Defocus curves at 3 months were illustrated in Fig. 1. Without distance correction, the curves showed two peaks of maximum vision, corresponding to near and distance focus. Besides, the binocular defocus curve showed better visual acuity in comparison with the monocular defocus curve at each step (P < 0.05, Paired t test).

Contrast Sensitivity Function

Figure 2 illustrated the contrast sensitivity function under mesopic conditions after surgery. There were no statistically significant changes in contrast sensitivity function (CSF) at any spatial frequency at 1 week, 1 month and 3 months. CSF tested at 2.5 m and 1.25 m showed no significant differences between glare and no-glare conditions. However, at various clinical visits, log contrast sensitivity (LogCS) values were higher at 1.25 m compared with 2.5 m at 12 cycles per degree (cpd) and 18 cpd under glare or no-glare conditions (P < 0.05, Wilcoxon test).

Rotational Stability

The absolute IOL rotation angles were 2.69 ± 6.17°, 2.25 ± 2.59° and 2.06 ± 2.35° at 1 week, 1 month and 3 months, respectively, with no statistical significance. Totally 91.7%, 94.4% and 91.7% of patients showed IOL rotation angles below 5° at 1 week, 1 month and 3 months, respectively (Fig. 3). One patient had IOL rotation at 37° at 1 week. An additional surgery was performed to realign the IOL axis in this patient. The IOL rotated 11° in the same direction at 1 month. At 3 months, the IOL had about 9° rotation compared with the primary design.

Vector Analysis of Refractive Astigmatism

Table 3 showed the vector analysis of refractive astigmatism using the Alpins vectorial method during the follow-up period. Target induced astigmatism (TIA) was 1.53 ± 0.88 D (Fig. 4A), and surgically induced astigmatism (SIA) levels were 1.49 ± 0.90 D, 1.50 ± 0.92 D and 1.53 ± 0.90 D at 1 week, 1 month and 3 months, respectively. SIA remained stable without significant changes during the follow-up period. However, SIA gradually tended to be closer to TIA until the 3-month visit (Fig. 4B). The difference between TIA and SIA showed no statistical significance.

Table 3

Vector analysis using the Alpins vectorial method during follow-up.
		1 W			1M			3M
SIA (D)	Mean ± SD	1.49	±	0.90	1.50	±	0.92	1.53	±	0.90
	Median	1.34			1.34			1.40
	Range	0.00	,	3.28	0.00	,	3.75	0.00	,	3.28
DV (D)	Mean ± SD	0.26	±	0.20	0.40	±	0.35 †	0.34	±	0.26
	Median	0.18			0.26			0.26
	Range	0.01	,	0.80	0.03	,	1.66	0.03	,	1.20
TRQ (D)	Mean ± SD	-0.08	±	0.21	-0.08	±	0.37	-0.08	±	0.30
	Median	0.18			0.00			-0.02
	Range	-0.65	,	0.43	-1.23	,	0.50	-0.80	,	0.74
FE (D)	Mean ± SD	1.47	±	0.91	1.44	±	0.95	1.50	±	0.91
	Median	1.34			1.34			1.39
	Range	0.00	,	3.28	-0.11	,	3.75	0.00	,	3.28
CI	Mean ± SD	0.95	±	0.44	0.99	±	0.46	0.93	±	0.40
	Median	1.00			1.01			1.01
	Range	0.00	,	2.80	0.00	,	2.80	0.00	,	1.86
SIA, surgically induced astigmatism; DV, difference vector; TRQ, torque; FE, flattening effect; CI, correction index.
1W, 1 week after surgery; 1M, 1 month after surgery; 3M, 3 months after surgery.
†, P < 0.05, Paired t test.

The difference vector (DV) was significantly higher at 1 month (0.40 ± 0.35 D) compared with 1 week (0.26 ± 0.20 D) (P < 0.05, Paired t test). At 3 months, the DV was 0.34 ± 0.26 D (Fig. 4C). Flattening effect (FE) values were 1.47 ± 0.91 D, 1.44 ± 0.95 D and 1.50 ± 0.91 D at 1 week, 1 month and 3 months, respectively. The FE showed a lower trend compared with SIA at all postoperative visits without significant differences. The correction index (CI) was stable with no significant changes after surgery, with a value of 0.93 ± 0.40 at 3 months.

Questionnaires and Visual Quality

At 3 months, the mean overall Visual Function Index-14 (VF-14) score was 96.2 ± 4.9. Satisfaction levels for visual acuity were 88.9%, 83.3% and 66.7% for far, intermediate and near distances, respectively (Fig. 5A). Totally 88.9% of patients required no spectacles at far and intermediate distances. A total of 66.7% of patients used no spectacle for near visual tasks (Fig. 5B). 61.1% of patients had no halo and glare perception. As for starburst, 77.8% patients did not feel disturbed (Fig. 5C). Totally 94.4% of patients would choose the same IOL again, and 94.4% of patients would recommend the IOL and surgery to their families and friends (Fig. 5D).

With the development of IOL design, visual function and patient satisfaction after cataract surgery are improving. Instead of correcting visual acuity at a fixed distance using monofocal IOL, multifocal IOL can compensate for presbyopia at near distance. Combined with the toric design, multifocal toric IOL allows surgeons to have more precise control of astigmatism and increases predictability. The current study demonstrated the clinical outcomes of multifocal toric IOL for cataract treatment in patients with long axial length and corneal astigmatism.

In this study, CDVA and UDVA were significantly improved after cataract surgery with the implantation of multifocal toric IOL. Generally, the refractive error is large in the long axial length.^13,14 A previous study reported that long axial length was associated with a greater possibility of hyperopia shift after cataract surgery. Traditional IOL formulas, such as Haigis-L and SRK-T, were recommended for IOL power calculation in patients with long axial length.¹⁵ In addition, newly published reports suggest that the Barrett Universal II formula based on the True-K value is useful for IOL power calculation for long axial length eyes.^15–17 The current study had similar results, using the Barrett Universal II formula for multifocal toric IOL calculation, with approximately 83.3% of the patients having postoperative spherical equivalent ranging from − 0.25 D to + 0.25 D. Almost all patients were close to the emmetropic status after cataract surgery, which was the base for improved UIVA and UNVA.

The defocus curve is a convincing tool for evaluating the visual performance of multifocal IOL using different levels of defocus.¹⁸ The defocus curves in the current study showed two peaks of maximum vision, corresponding to near (2.50 to 3.00 D defocus level) and distance (0.00 D defocus level) focus. As to the visual performance of intermediate distance, vision results were also within the acceptable range. Alió et al. reported similar defocus curve results after the implantation of AT LISA toric 909M multifocal toric IOL.^6,19 Therefore, this multifocal toric IOL could provide a wide range of functional vision for long axial patients, covering the most working distances in daily life.

Contrast sensitivity is a concern after multifocal IOL implantation surgery. In the present study, CSF was tested under low mesopic condition, which was similar with previous studies.^6,20 During the postoperative follow-up period, CSF showed no significant changes. At each clinical visit, LogCS was higher for 1.25 m compared with 2.5 m at high spatial frequency (12 cpd and 18 cpd) under glare or no-glare conditions. Montés-Micó et al. reported better CSF for high spatial frequency at near distance after multifocal implantation.²¹ Besides, the overall CSF results were comparable with those of Ogawa et al. using the same AT LISA toric 909M multifocal toric IOL for cataract treatment in patients with long axial length.³ Thus, corroborating previous reports, CSF results were acceptable after multifocal toric IOL implantation in cataract patients with long axial length.

To determine the effectiveness of the astigmatism correction of multifocal toric IOL for cataract patients with long axial and corneal astigmatism, the Alpins method was used to perform vector analysis.^22,23 In this study, the magnitudes of SIA and TIA were close without statistically significant differences. The DV was significantly changed at 1 month compared with 1 week, which might be due to one patient accepted surgery to realign the IOL axis. The CI remained slightly less than 1.0 indicating a trend of undercorrection, which was helpful for maintaining the visual function caused by customary astigmatism axial.²⁴ Similarly, Alió et al. reported the AT LISA toric 909M IOL had a slight trend of overcorrection of refractive astigmatism.⁶ Bellucci et al. showed the residual refractive astigmatism with average value of 0.50 D after implantation of the AT LISA toric 909M IOL.⁹ The clinical results confirmed that even in patients with long axial length, the AT LISA toric 909M IOL could achieve stable and predictable astigmatism correction.

The rotational stability of the AT LISA toric 909M IOL was evaluated with a slit lamp. Our results showed more than 90% of patients had IOL rotation less than 5°. Bellucci et al. reported 95.8% of patients implanted with the AT LISA toric 909M IOL showed no rotation over 5°.⁹ With the same IOL, Alió et al. reported a rotation of 3.10 ± 5.44°.⁶ In the current study, only one patient underwent a further surgery to realign the IOL axis. This patient had a wider WTW (12.8 mm) and a thicker LT (4.21 mm). Usually, capsular bags are larger in cases with long axial length compared with normal eyes.²⁵ Axial length is significantly and positively associated with rotational stability.^26,27 In terms of toric IOL implantation in patients with long axial length, IOL rotational stability remains challenging. More attention should be paid to these biased biometric parameters. However, this study firstly reported the excellent rotational stability of the AT LISA toric 909M IOL in patients with long axial length. This phenomenon might be due to its plate-haptic design and hydrophilic acrylic material with a hydrophobic surface, which could keep IOL stable 1 to 7 days after implantation.^9,28 Moreover, the digital tracking system for intraoperative toric IOL alignment was efficient in improving axial precision.²⁹ The image-guided positioning technology helps ensure refractive outcomes.³⁰

There were limitations in this study. Due to strict inclusion criteria for multifocal toric IOL implantation, the number of eligible patients with long axial length was limited. Thus, we enrolled patients with axial length over 25.0 mm. Future study should be more stringent for axial length. Besides, rotational stability was assessed with a slit lamp, which might be limited in precision. In the future, objective assessments using commercial systems would provide more convincing data.

In conclusion, plate-haptic diffractive multifocal toric IOL implantation improves distance and near visual functions and reduces astigmatism in cataract patients with long axial length and corneal astigmatism, which is helpful to reduce dependence on spectacles and increase patient satisfaction after cataract surgery.

Subjects

This prospective study was approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine and followed the tenets of the Declaration of Helsinki. All patients were fully informed about the surgical process, the IOL, and possible outcomes. Signed informed consent was obtained from all subjects. Complete ocular examinations were performed before the cataract surgery, including a review of medical and family histories, corrected distance visual acuity (CDVA) assessment, slit-lamp evaluation, fundoscopy findings, mesopic and photopic pupil diameter (PD) measurements, endothelial cell count (Tomey EM-4000; Tomey Co, Nagoya, Japan) and contrast sensitivity function (CSV-1000E; Vector Vision Co, Greenville, Ohio, USA). Ocular biometric indexes were evaluated with a corneal tomography Pentacam HR system (OCULUS Optikgeräte GmbH, Wetzlar, Germany) and an IOLMaster 700 (Carl Zeiss Meditec AG, Jena, Germany), including true keratometry (TK), true corneal astigmatism (ΔTK), angle Kappa, the root mean square of corneal high-order aberration for 4-mm diameter (HOA RMS), axial length (AL), anterior chamber depth (ACD), lens thickness (LT) and white-to-white distance (WTW).

Inclusion criteria were visually significant cataract requiring a surgical refractive solution for far and near distance vision, AL over 25.0 mm, ΔTK over 0.75 D, angle Kappa within 0.5 mm, and HOA RMS within 0.5 mm. Exclusion criteria were glaucoma, retinal disease, irregular corneal astigmatism, corneal disease, uveitis, neurophthalmic disease, abnormality of the iris, zonules or lens, or a history of ocular trauma or surgery.

Intraocular Lenses and Surgical Technique

AT LISA toric 909M is a plate-haptic diffractive bifocal IOL with hydrophobic surface properties. It is a foldable IOL made of hydrophilic acrylate material with 25% water content. Its refractive index is 1.46, with an A-constant of 118.3. It is a single-piece of 4-haptic design with a total diameter of 11.0 mm, an optic diameter of 6.0 mm, and an angulation of 0 degree. The anterior surface loads the aspheric and toric components. The posterior surface bears the diffractive structures providing a near addition (ADD) of + 3.75 D at the IOL plane. The theoretical transmitted light is distributed 35% and 65% to near and distant focus, which is independent from pupil size. The Barrett Universal II formula based on True-K value was used for IOL power calculation.

The same chief surgeon (W.X.) uneventfully performed all surgeries by microincision phacoemulsification with the main incision of 2 mm. Topical anesthesia with 0.5% Alcaine was used for all cases. Callisto Eye System (Carl Zeiss Meditec AG, Jena, Germany) was used to mark the 135° main incision and 45° side incision, to guide the 5-mm diameter capsulorhexis and to align the IOL axis. After capsulorhexis and phacoemulsification, the posterior capsule was polished. The IOL was inserted in the capsular bag through a 2.0-mm incision with an AT.Smart Cartridge set (Carl Zeiss Meditec AG, Jena, Germany) and an AT.Shooter A2-2000 injector (Carl Zeiss Meditec AG, Jena, Germany). Viscoelastics were removed, and the incisions were sealed by hydration. Postoperative topical therapy applied 0.5% levofloxacin, 1% prednisolone and 0.1% diclofenac sodium.

Clinical Evaluations

Postoperatively, patients were assessed at 1 day, 1 week, 1 month and 3 months. At 1 day, CDVA, uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), intraocular pressure, and the integrity of the anterior segment were examined.

At 1 week, 1 month and 3 months, the analysis also encompassed subjective and objective refractions. IOL rotation was assessed with a slit lamp by checking the axis of IOL markers. Contrast sensitivity function (CSF) under monocular statues tested at 2.5 m and 1.25 m under mesopic conditions with and without glare. Absolute values of log contrast sensitivity (LogCS) were obtained for spatial frequencies of 3.0 cycles per degree (cpd), 6.0 cpd, 12.0 cpd, and 18.0 cpd. The vector analysis of refractive astigmatic changes was performed by the Alpins vectorial method at the corneal plane.^22,23 The following vectors were evaluated, including target induced astigmatism (TIA), surgically induced astigmatism (SIA), difference vector (DV), torque (TRQ), flattening effect (FE), and correction index (CI).

Additionally, at 3 months postoperatively, defocus curves were analyzed to characterize near and intermediate visual functions. The curves were obtained under monocular and binocular statuses without distance correction (UDVA). Plus lenses were added in 0.50 D steps from + 2.00 D to -4.00 D, and visual acuity was recorded for each type of blur. Visual Function Index-14 (VF-14) was used to evaluate the degree of difficulty in performing 14 vision-targeted daily activities.³¹ The VF-14 scores range between 0 and 100, representing the worst and best possible functions, respectively. All patients completed a self-developed questionnaire for different test distances, including the satisfaction of visual acuity (from “0 [never] to “4 [always]”) and the frequency of spectacle usage (from “0 [unsatisfied]” to “4 [very satisfied]”). Besides, patients also evaluated the incidence rates of photic phenomena, including halo, glare, starburst, and others (from “0 [none]” to “4 [severe]”). Finally, patients were asked two questions: “Would you choose the same IOL again?” (Yes/No) and “Would you recommend the current IOL to your family and friends?” (Yes/No).

Statistical Analysis

Visual acuity data were expressed in the logMAR notation. Data analysis was performed with the Statistical Package for the Social Sciences software (SPSS ver. 17; IBM, Armonk, NY, USA). The Kolmogorov-Smirnov test was used to check the data normality. Parameters with normal distribution were compared by the paired t test between preoperative and postoperative data or between consecutive postoperative visits. For parameters with skewed distribution, the Wilcoxon rank sum test was used to examine differences. Statistical significance was defined as P < 0.05.

Competing interests

The authors declare no competing interests.

Clinical trial number

NCT04833491.

Funding

support:

Author Contribution

Conceptualization: Wen XU, Zhe XU and Shuang NI; Data curation: Zhe XU, Jingwen WANG, Shuang NI, Jingwei XU, Jianxia FANG, Sha ZHU; Investigation: Zhe XU and Ce SHI; Writing - original draft: Zhe XU, Ce SHI and Wen XU.

Acknowledgement

The authors would like to acknowledge the technical support from Carl Zeiss Meditec AG for this manuscript.

Data Availability

The datasets generated and analyzed during the current study are not publicly available due to data protection regulations but are available from the corresponding author on reasonable request.

Tideman, J. W. et al. Association of axial length with risk of uncorrectable visual impairment for europeans with myopia. JAMA Ophthalmol 134, 1355–1363, doi:10.1001/jamaophthalmol.2016.4009 (2016).
Leske, M. C., Wu, S. Y., Nemesure, B. & Hennis, A. Risk factors for incident nuclear opacities. Ophthalmology 109, 1303–1308, doi:10.1016/s0161-6420(02)01094-1 (2002).
Ogawa, T., Shiba, T. & Tsuneoka, H. Usefulness of implantation of diffractive multifocal intraocular lens in eyes with long axial lengths. J Ophthalmol 2015, 956046, doi:10.1155/2015/956046 (2015).
Hashemi, H. et al. Global and regional estimates of prevalence of refractive errors: Systematic review and meta-analysis. J Curr Ophthalmol 30, 3–22, doi:10.1016/j.joco.2017.08.009 (2018).
Sigireddi, R. R. & Weikert, M. P. How much astigmatism to treat in cataract surgery. Curr Opin Ophthalmol 31, 10–14, doi:10.1097/icu.0000000000000627 (2020).
Alió, J. L., Piñero, D. P., Tomás, J. & Plaza, A. B. Vector analysis of astigmatic changes after cataract surgery with implantation of a new toric multifocal intraocular lens. J Cataract Refract Surg 37, 1217–1229, doi:10.1016/j.jcrs.2010.12.064 (2011).
Alió, J. L. et al. Optical analysis, reading performance, and quality-of-life evaluation after implantation of a diffractive multifocal intraocular lens. J Cataract Refract Surg 37, 27–37, doi:10.1016/j.jcrs.2010.07.035 (2011).
Zhu, Y., Zhong, Y. & Fu, Y. The effects of premium intraocular lenses on presbyopia treatments. Adv Ophthalmol Pract Res 2, 100042, doi:10.1016/j.aopr.2022.100042 (2022).
Bellucci, R. et al. Visual acuity and refraction with a diffractive multifocal toric intraocular lens. J Cataract Refract Surg 39, 1507–1518, doi:10.1016/j.jcrs.2013.04.036 (2013).
Chen, X., Xu, J., Chen, X. & Yao, K. Cataract: Advances in surgery and whether surgery remains the only treatment in future. Adv Ophthalmol Pract Res 1, 100008, doi:10.1016/j.aopr.2021.100008 (2021).
Zhu, X., He, W., Zhang, K. & Lu, Y. Factors influencing 1-year rotational stability of AcrySof Toric intraocular lenses. Br J Ophthalmol 100, 263–268, doi:10.1136/bjophthalmol-2015-306656 (2016).
Zhu, X., Meng, J., He, W., Rong, X. & Lu, Y. Comparison of the rotational stability between plate-haptic toric and C-loop haptic toric IOLs in myopic eyes. J Cataract Refract Surg 46, 1353–1359, doi:10.1097/j.jcrs.0000000000000259 (2020).
Bernardes, J., Raimundo, M., Lobo, C. & Murta, J. N. A comparison of intraocular lens power calculation formulas in high myopia. J Refract Surg 37, 207–211, doi:10.3928/1081597x-20201123-01 (2021).
Petermeier, K. et al. Intraocular lens power calculation and optimized constants for highly myopic eyes. J Cataract Refract Surg 35, 1575–1581, doi:10.1016/j.jcrs.2009.04.028 (2009).
Kane, J. X. & Chang, D. F. Intraocular lens power formulas, biometry, and intraoperative aberrometry: A review. Ophthalmology 128, e94-e114, doi:10.1016/j.ophtha.2020.08.010 (2021).
Melles, R. B., Holladay, J. T. & Chang, W. J. Accuracy of intraocular lens calculation formulas. Ophthalmology 125, 169–178, doi:10.1016/j.ophtha.2017.08.027 (2018).
Chen, Y., Wei, L., He, W., Lu, Y. & Zhu, X. Comparison of Kane, Hill-RBF 2.0, Barrett Universal II, and Emmetropia Verifying Optical Formulas in eyes with extreme myopia. J Refract Surg 37, 680–685, doi:10.3928/1081597x-20210712-03 (2021).
Plaza-Puche, A. B. & Alio, J. L. Analysis of defocus curves of different modern multifocal intraocular lenses. Eur J Ophthalmol 26, 412–417, doi:10.5301/ejo.5000780 (2016).
Alió, J. L. et al. Visual and optical performance with two different diffractive multifocal intraocular lenses compared to a monofocal lens. J Refract Surg 27, 570–581, doi:10.3928/1081597x-20101223-01 (2011).
Mendicute, J. et al. Toric intraocular lens versus opposite clear corneal incisions to correct astigmatism in eyes having cataract surgery. J Cataract Refract Surg 35, 451–458, doi:10.1016/j.jcrs.2008.11.043 (2009).
Montés-Micó, R., España, E., Bueno, I., Charman, W. N. & Menezo, J. L. Visual performance with multifocal intraocular lenses: mesopic contrast sensitivity under distance and near conditions. Ophthalmology 111, 85–96, doi:10.1016/s0161-6420(03)00862-5 (2004).
Alpins, N. Astigmatism analysis by the Alpins method. J Cataract Refract Surg 27, 31–49, doi:10.1016/s0886-3350(00)00798-7 (2001).
Alpins, N. A. A new method of analyzing vectors for changes in astigmatism. J Cataract Refract Surg 19, 524–533, doi:10.1016/s0886-3350(13)80617-7 (1993).
Abulafia, A., Hill, W. E., Franchina, M. & Barrett, G. D. Comparison of methods to predict residual astigmatism after intraocular lens implantation. J Refract Surg 31, 699–707, doi:10.3928/1081597x-20150928-03 (2015).
Zhu, X. & Lu, Y. Detection and influencing factors of capsular bag distention syndrome after cataract surgery using the Pentacam Scheimpflug system. Am J Ophthalmol 156, 1134–1140.e1134, doi:10.1016/j.ajo.2013.07.028 (2013).
Visser, N., Nuijts, R. M., de Vries, N. E. & Bauer, N. J. Visual outcomes and patient satisfaction after cataract surgery with toric multifocal intraocular lens implantation. J Cataract Refract Surg 37, 2034–2042, doi:10.1016/j.jcrs.2011.05.041 (2011).
Patnaik, J. L. et al. Association between axial length and toric intraocular lens rotation according to an online toric back-calculator. Int J Ophthalmol 15, 420–425, doi:10.18240/ijo.2022.03.08 (2022).
Werner, L. Intraocular lenses: overview of designs, materials, and pathophysiologic features. Ophthalmology 128, e74-e93, doi:10.1016/j.ophtha.2020.06.055 (2021).
Mayer, W. J. et al. Comparison of visual outcomes, alignment accuracy, and surgical time between 2 methods of corneal marking for toric intraocular lens implantation. J Cataract Refract Surg 43, 1281–1286, doi:10.1016/j.jcrs.2017.07.030 (2017).
Hura, A. S. & Osher, R. H. Comparing the Zeiss Callisto Eye and the Alcon Verion Image Guided System toric lens alignment technologies. J Refract Surg 33, 482–487, doi:10.3928/1081597x-20170504-02 (2017).
Khadka, J. et al. Translation, cultural adaptation, and Rasch analysis of the visual function (VF-14) questionnaire. Invest Ophthalmol Vis Sci 55, 4413–4420, doi:10.1167/iovs.14-14017 (2014).

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Clinical Outcomes of Plate-Haptic Diffractive Multifocal Toric IOL in Cataract Eyes with Long Axial Length and Corneal Astigmatism

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Abstract

Figures

INTRODUCTION

RESULTS

Demographic

Visual Outcomes

Contrast Sensitivity Function

Rotational Stability

Vector Analysis of Refractive Astigmatism

Questionnaires and Visual Quality

DISCUSSION

METHODS

Subjects

Intraocular Lenses and Surgical Technique

Clinical Evaluations

Statistical Analysis

Declarations

Competing interests

Funding

Author Contribution

Acknowledgement

Data Availability

References

Additional Declarations

Status:

Version 1