Comparative analysis of visual quality between unilateral implantation of a trifocal intraocular lens and a rotationally asymmetric refractive multifocal intraocular lens

INTRODUCTION

The Catquest-9SF questionnaire was used to evaluate visual function and satisfaction after cataract surgery since 2008.It consists of 9 items. Items A and B are global assessments about difficulty in daily life and vision satisfaction. Item C1-C7 are concerned with specific daily-life activities. There are 4 response options for each item: 4 =“very great difficulty or very dissatisfied”, 3 =“great difficulty or fairly dissatisfied”,2 =“some difficulty or fairly satisfied” and 1=“no difficulty or very satisfied”. Additional option “Cannot decide” is considered as missing data in analysis. Halo and glare symptoms were evaluated with a questionnaire. The response to the questionnaire was classified into: none, slight, moderate,and severe.

The first multifocal IOL on the market were manufactured in the late 1980s. Over the past 30y, multifocal IOLs have developed rapidly, but they are no more than diffractive,refractive or a combination of both. The previous refractive multifocal IOLs achieve multifocality by the design of annular zones that representing different refractive power and most of them are rotationally symmetric. These refractive models have many limitations, such as pupil dependence, high sensitivity for lens centration, intolerance to kappa angle, loss of contrast sensitivity, halos and glare. In order to modify limitations of traditional refractive multifocal IOLs, refractive multifocal IOLs with designs of rotational asymmetry have been introduced. This type of design makes light focus on one focal point for near in a particular sector and the other sector of lens is in charge of focal point for distance. So the refractive multifocal IOLs is good at near and distance vision, with similar contrast sensitivity to monofocal IOLs, independence of pupil size, low sensitivity to lens decentration and less photopsia than refractive concentric multifocal IOLs.

生：我今天特別開心，知道（魔方）一共有27塊，但是我看（魔方）轉動的時候，中間那個地方好像不動，我就想會不會少一塊，結果是真的少一塊！

The diffractive multifocal IOLs based on Huygens-Fresnel principle. The physical optics shows that light has both wave and particle characteristic. Light encounters obstacles, if the size of obstacles is close to or less than the wavelength, light diffraction occurs. There are concentric diffractive steps in the central zone of optic that can produce foci. Bifocal IOLs only has a focus for far and a focus for near, not for intermediate,therefore, in some situations, the intermediate vision may not live up to expectation. With the use of computers,laptops, ipads and smart phones, good intermediate vision is becoming more and more important for patients. The first trifocal diffractive IOL was released in 2010, which provide a significant improvement in the intermediate vision.

呂凌子說你這話我不愛聽！見過售后的，沒見過貴廠這樣售后的。客戶購買的是防盜門，防盜門任何一個部件出了問題都是防盜門的質量問題。防盜門出了質量問題我只能找防盜門生產廠家。怎么追究鎖具廠的責任是你們的事，我懶得管，也管不了！

力學性能要求：Rp0.2≥300MPa，Rm≥480MPa，A≥20%，AK V≥50J（20℃時）。超聲波無損檢測的檢驗等級按EN12680一級，質量等級按SN320第10部分進行驗收。

To our knowledge, this study is the first comparison between the performance of trifocal IOLs and rotationally asymmetric refractive multifocal IOLs in basis of visions at different distances, refractive outcomes, defocus curves, contrast sensitivity, quality of vision and optical phenomena after unilateral cataract surgery.

SUBJECTS AND METHODS

All procedures in the study measured up to the ethical standards of the local Ethics Committee and conform to the Helsinki Declaration and its subsequent amendments. Each patient was invited to enter the study and signed informed written consent. Clinical Trial Registry:ChiCTR1900022519.

Monocular defocus curves of both groups at 3mo postoperatively are shown in Figure 2. There were no significant statistical differences at any vergence between the trifocal group and the refractive multifocal group. The curves of both groups were almost identical and had two peaks. The first peak of visual acuity representing the best corrected distance visual acuity was obtained at 0.00 D. The second peak of visual acuity representing the best corrected near visual acuity at 40 cm was observed at -2.50 D. Due to the +1.66 D addition power for intermediate focus, the defocus curve of trifocal IOL is smoother than that of refractive multifocal IOL in the range of 0-2.5 D, with vision of 0.2 logMAR or better.

This study consisted of 60 eyes of 60 patients suffering unilateral cataract surgery with implantation of IOL between July 2018 and June 2020 at Xi’an Forth Hospital, Xi’an, China.Inclusion criteria included: agerelated cataract, corneal astigmatism ＜1.0 D, corneal higherorder aberration ＜0.3 μm, kappa angle ＜0.3 mm, alpha angle＜0.3 mm. Exclusion criteria included: corneal degeneration,glaucoma, ischemic optic neuropathy, retinal and macular diseases, lens subluxation, previous corneal and intraocular surgery. The ophthalmologist recommended a specific type of IOL according to patient’s occupation, habits, hobbies and demands. There were two groups: patients receiving a trifocal IOL AT LISA tri 839MP (trifocal IOL group) and a rotationally asymmetric refractive IOL LS-313 MF30 (refractive multifocal IOL group).

2.2輸卵管線形造口取胚術:主要治療方式:在患者輸卵管系膜對側,沿著患者輸軟管長軸將各層組織切開,其長度在2cm左右,將妊娠物取出后,對患者進行止血,可采用腸線進行縫合,也可不行縫合,等待其自愈。該手術方式適用于保留生育功能的患者[9]

All surgeries in this study were phacoemulsification, operated by the same surgeon, with a Stellaris platform (Bausch & Lomb Incorporated, USA).Topical anaesthesia was used in all surgeries. The procedures included a 2.2-mm incision on the steep meridian according to the keratometry obtained in IOL Master 700 (Carl Zeiss Meditec, Germany) preoperatively, a continuous central circular capsulorhexis (approximately 5.5 mm diameter),hydrodissection, phacoemulsification, aspiration of cortex,implantation of IOL. Postoperatively, a topical treatment included a combination of antibiotics and steroids (levofloxacin hydrochloride 0.5%, 4 times a day for 2wk, tobramycin 0.3%and dexamethasone 0.1%, 4 times a day for 2wk).

All postoperative refraction were carried out with OPD Scan III. Refractive cylinders in both groups were roughly the same,but the spherical dioptre in refractive multifocal group was more myopic than that in trifocal group. Since the calculation of spherical equivalent is based on spherical dioptre, a similar result was found in spherical equivalent. Why is there a difference about spherical dioptre evaluated by auto refractometer between trifocal IOL and refractive multifocal IOL? van der Lindenreported that after implantation of rotationally asymmetric multifocal IOL, the spherical dioptre with automated refraction was+0.98 D more myopic than subjective manifest refraction.Compared to subjective manifest refraction, the spherical equivalent with automated refraction was +1.11 D more myopic. Albarrán-Diegofound a similar result that the difference between automated refraction and subjective manifest refraction was about 1.25 D in rotationally asymmetric refractive multifocal IOL. We can infer from the above studies that spherical refraction measuring with auto refractometer may cause mean error of +1.0 D approximately in rotationally asymmetric multifocal IOL.In our study, the difference of mean spherical dioptre between trifocal IOL and refractive multifocal IOL was+0.83±0.60 D. The reason for pseudomyopia with auto refractometer in the sector-shaped addition multifocal IOLs may lie in its geometrical asymmetry. Two different refractive surfaces in these IOLs yield two foci in pupil area. Therefore, for the emmetropia implanted with refractive multifocal IOL, auto refractometer detects two refractions of 0.00 D and -2.5 D and results in an average of about -1.25 D. In addition to refractive measuring inaccuracy, other differences caused by geometrical asymmetry is worthy of further study.

網絡語言的出現對漢語言的語法結構產生了一定的影響，使漢語言文字和詞語的組合出現了混亂的情況，如“我靠”“我暈”“犀利哥”“你在玩什么東東呀”“哥做的不是作業，做的是煩惱”等等。這樣一來，漢語言就變得不夠規范和標準了。網絡語言在現階段十分發達，人們在網絡聊天的過程中經常出現錯別字，人們形成了打錯字的習慣，如“一往情深”寫成“一網情深”等。這樣，就會讓人們的閱讀變得更加困難，錯誤的語句或者詞匯就會讓語法規律不夠完善，也會減少語言自身的原有韻味。[1]

SPSS software 23.0 for windows was used for statistical analysis. The normal distribution of all data was tested by Shapiro-Wilk test. When the data were normally distributed, the Student’s-test was used to analyze the comparison between groups. When the data didn’t conform to the normal distribution, the Mann-Whitneytest was used.The Fisher exact test was used to assess sex and questionnaire about halo and glare between groups. Differences were considered statistically significant with avalue less than 0.05.

The data of visual acuity in previous studies are used as parameters in sample-size calculation. A study by Bilbao-Calabuigshows monocular uncorrected near visual acuity (UNVA) at 3mo postoperatively was 0.07±0.10 logMAR in AT LISA tri839 MP IOL. The monocular UNVA of LS-313 MF30 IOL was 0.16±0.14 logMAR in another study.Assuming that a significance level is 0.05 and a test power is 0.8, the sample size is calculated with the above parameters(PASS for windows, version15.0). Thirty eyes were required in each group.

All patients had a comprehensive preoperative ophthalmological examination containing visual acuity, intraocular pressure, slit-lamp, fundoscopy, corneal topography, endothelial cell count analysis and biometry with IOL Master 700. Uncorrected and corrected visual acuity at 5 m,80 and 40 cm were all tested by decimal chart under photopic condition. Then the visual acuity was converted to logarithm of the minimum angle of resolution (logMAR) for analysis.

A large sample study reported that Barrett universal II formula had the highest accuracy for eyes with axial length ＞25.0 mm,followed by Olsen and Haigis formula. In 2018, Barrett universal II and Olsen were unavailable in our hospital. Due to overcorrection of hyperopic outcomes, the Wang-Koch adjustment for eyes with axial length ＞25.0 mm resulted in myopic errors, especially for Haigis formula. The modified Wang-Koch adjustment for longer eyes performed better only for Holladay 1but not for SRK/T. For the above reasons,we chose Haigis formula without adjustment to calculate the IOL power and the target refraction was closest to emmetropia.Follow up examinations were carried out at 1d, 1 and 3mo postoperatively. Three months after surgery, additional measurements were performed including refraction with the OPD Scan III (Nidek Co. Ltd., Japan), contrast sensitivity with RM800 Contrast Sensitivity unit (Raymon Photoelectricity Tech.Co., China), defocus testing, Catquest-9SF questionnaire and questionnaire about optical phenomena. Monocular contrast sensitivity was evaluated with and without glare under photopic condition. Defocus testing was conducted monocularly, under photopic conditions, by adding lens from-4.0 D to +1.0 D in gradient of 0.5 D over distance-corrected refraction.

Presbyopia is a global problem impacting on more than a billion people. The incidence of uncorrected presbyopia is up to 34% in developed countries, and it is as high as 50%of the population over the age of 50 in developing countries.In 2015, there were 1.8 billion presbyopia patients worldwide,of which 826 million suffered from near vision impairment due to myopia and they had no or insufficient vision correction.Now available modalities for correcting presbyopia include spectacles, contact lenses, surgical approaches, pharmaceuticals and ciliary muscle electrostimulation. Scleral expansion,implantation of intraocular lens (IOL), inlays and laser refractive surgery are surgical approaches that have been carried out for years. Implantation of IOL is an effective alternative of presbyopia correction for people with cataract.According to the types of substitutes for lens, four strategies have been described: pseudophakia with monofocal IOLs,accommodative IOLs, multifocal IOLs, and extended depth of focus (EDOF) IOLs.

Lentis Mplus LS-313 MF30 is a rotationally asymmetric segmental refractive multifocal IOL, with a posterior aspheric distance vision zone and anterior +3.00 D sector-shaped near vision zone. It is a single-piece biconvex hydrophilic IOL with hydrophobic surface. Its overall length is 11.0 mm, too. It has a 6.0 mm optic with a 360° sharp posterior optic edge reducing the incidence of posterior capsular opacity. A flat haptic strengthens stability.

定理2 若定理1得證且公式φRNS.sec成立，則RNS協議具有機……