Effect of Cyclotorsion Compensation in Small Incision Lenticule Extraction Surgery for the Correction of Myopic Astigmatism: A Systematic Review and Meta-Analysis.

INTRODUCTION: Small incision lenticule extraction (SMILE) has made notable advancements in addressing myopic astigmatism. Nevertheless, the potential impact of cyclotorsion on surgical outcomes cannot be overlooked. This study aims to assess the effectiveness of cyclotorsion compensation technology in SMILE surgery for the correction of myopic astigmatism, examining its influence on postoperative visual quality. METHODS: A systematic review and meta-analysis were conducted. A comprehensive literature search was performed using databases, including PubMed, Web of Science, EMBASE, Cochrane Library, EBSCO, Scopus, CNKI, VIP, and Wan Fang. Studies meeting the criteria were selected and included. Data were independently extracted by three authors. Clinical outcome parameters were analyzed using Review Manager version 5.3. RESULTS: This meta-analysis included ten studies. The results showed that, compared with the control group (cyclotorsion compensation was not performed in SMILE), the following indicators in the cyclotorsion compensation group were: residual astigmatism (RA) [weighted mean difference (MD) = 0.73, 95% confidence interval (CI) + 0.26 to + 1.19, P = 0.002], spherical equivalent (SE) (MD = 1.99, 95% CI + 0.77 to + 3.21, P = 0.001), coma (MD = -0.06, 95% CI -0.08 to -0.04, P < 0.00001), higher-order aberrations (HOAs) (MD = -0.04, 95% CI -0.06 to -0.02, P < 0.0001), follow-up 6-month angle of error (AE) (MD = -2.67, 95% CI -3.71 to -1.63, P < 0.00001), and follow-up 6-month uncorrected distance visual acuity (UDVA) (MD = -0.05, 95% CI -0.08 to -0.01, P = 0.005), and the differences in results were statistically significant. However, the differences among correction index, index of success (IOS), targeted induced astigmatism (TIA), magnitude of error (ME), and spherical aberration (SA) were not statistically significant. CONCLUSION: Cyclotorsion compensation proves to be effective and predictable for correcting myopic astigmatism. The cyclotorsion compensation group demonstrated advantages over the control group in terms of postoperative residual astigmatism, and it induced fewer coma aberrations. Whether cyclotorsion compensation can lead to better visual quality remains to be seen, and further research on correcting myopic astigmatism through cyclotorsion compensation is warranted.

Impact of pupil and defocus ring intersection area on retinal defocus.

PURPOSE: With the rising prevalence of myopia, especially among the young, orthokeratology (Ortho-K) stands out as a promising approach, not only to reduce myopia but also to control the progression of axial length (AL). This study examined how the intersection area between the pupil and defocus ring influenced retinal defocus and axial growth after Ortho-K. METHODS: A case-control study was conducted with 100 participants (100 eyes). Both AL and the refraction difference value (RDV), that is, the peripheral refractive error measured with respect to the central value after wearing Ortho-K lenses, were determined. Subjects were categorised into two groups based on the size of the intersection area after 3 months of lens wear: Group A (<4.58 mm2 ) and Group B (≥4.58 mm2 ). RESULTS: Group B demonstrated significantly lower changes in AL and RDV at 30-40° and 40-53° compared with Group A after 3 months of lens wear (all p < 0.05). After 6 months of lens wear, Group B showed significantly lower changes in AL and RDV in the 40-53° region compared with Group A (all p < 0.05). Correlation analysis revealed that as the intersection area increased, the changes in AL and RDV at 0-53°, 30-40° and 40-53° eccentricity decreased after both 3 and 6 months of lens wear (all p < 0.01). CONCLUSIONS: A larger intersection area between the pupil and defocus ring within a certain time period can cause a greater amount of myopic defocus at 30-53° from the fovea. The results suggest that a larger intersection area might lead to more effective control of axial growth.

Deep neural network with self-attention based automated determination system for treatment zone and peripheral steepened zone in Orthokeratology for adolescent myopia.

PURPOSE: The aim of this study is to develop an automatic model based on deep learning techniques for determining the Treatment Zone (TZ) and Peripheral Steepened Zone (PSZ) following Orthokeratology (OK) treatment. METHODS: A total of 1346 corneal topography maps were included in the study. A deep neural network based on the Segformer architecture was constructed to automatically detect TZ and PSZ. The model was optimized and trained multiple times, and the areas of TZ, PSZ, and TZ decentration were calculated based on the segmentation results. RESULTS: The mean Intersection over Union (mIoU) of the overall segmentation results of the model reached over 97% after multiple training with different optimization methods, and the IoU for the TZ and PSZ segmentation tasks were 98.08% and 94.54% in test set, respectively. Moreover, the model demonstrated high consistency with the expert annotation for the TZ segmentation, while a significant difference was found in the PSZ segmentation and expert annotation due to several interference factors. CONCLUSION: This study presents an efficient and repeatable system for clinical research, based on a deep neural network that accurately determines TZ and PSZ after OK treatment using the Segformer architecture. However, further deployment validation may be necessary.

Observation of peripheral refraction in myopic anisometropia in young adults.

AIM: To investigate the differences in retinal refraction difference values (RDVs) of adult patients with myopic anisometropia compared with those without myopic anisometropia, and to investigate the relationship between ocular biometric measurements and relative peripheral refraction. METHODS: This clinical observation study included 130 patients with myopia (-0.25 to -10.00 D) between October 2022 and January 2023 aged between 18 and 40y. The patients were divided into anisometropia (n=63; difference in binocular anisometropia ≥1.00 D) and non-anisometropia (n=67; difference in binocular anisometropia <1.00 D) groups accordingly. Ocular biometric measurements were performed by optical biometrics and corneal topography to assess the steep keratometry (Ks), flap keratometry (Kf), axial length (AL), corneal astigmatism (CYL; Ks-Kf), surface regularity index (SRI), surface asymmetry index (SAI), and central corneal thickness (CCT). The RDV was measured at five retinal areas from the fovea to 53 degrees (RDV-0-10, RDV-10-20, RDV-20-30, RDV-30-40, and RDV-40-53), the total RDV (TRDV) of 53 degrees, and four regions, including RDV-superior, RDV-inferior, RDV-temporal, and RDV-nasal. An analysis of Spearman correlation was carried out to examine the correlation between RDV and the spherical equivalent (SE) and ocular biological parameters. RESULTS: Within RDV-20-53, both groups showed relative hyperopic defocus, and the increase in RDV corresponds to the increase in eccentricity. In the myopic anisometropia group, the TRDV, RDV-20-53, RDV-superior, and more myopic eyes had significantly higher RDV-temporal values than less myopic eyes. (P<0.05). In the non-anisometropia group, there was no significant difference in the RDV between the more and less myopic eyes at different eccentricities (P>0.05). There was a negative correlation between SE and TRDV (r=-0.205, P=0.001), RDV-20-53 (r=-0.281, -0.183, -0.176, P<0.05), RDV-superior (r=-0.251, P<0.001), and RDV-temporal (r=-0.230, P<0.001), a negative correlation between CYL and RDV-10-30 (r=-0.147, -0.180, P<0.05), and a negative correlation between SRI and RDV-0-20 (r=-0.190, -0.170, P<0.05). AL had a positive correlation with RDV-20-30 (r=0.164, P=0.008) and RDV-temporal (r=0.160, P=0.010). CONCLUSION: More myopic eyes in patients with myopic anisometropia show more peripheral hyperopic defocus. Diopter and corneal morphology may affect peripheral retinal defocus.

Retinal Vascular Oxygen Saturation in a Sample of Chinese Myopic Adults.

Purpose: The aim of the study was to investigate the normal retinal vascular oxygen saturation and to elucidate the factors affecting it or associated with it in a Chinese population. Methods: This was a population-based observational cross-sectional study. Chinese myopic adults aged 18 to 45 years old were enrolled. Spherical equivalent (SE) and ocular biometry, including average keratometry (K), central corneal thickness, intraocular pressure, and axial length, were measured. The retinal arteriolar (SaO2) and venous (SvO2) oxygen saturation were measured after pupil dilatation. Results: A total of 1373 participants were enrolled, and the mean age, SE, SaO2, and SvO2, were 26.31 ± 6.93 years, -6.40 ± 3.12 D, 93.47% ± 1.58%, and 63.08% ± 4.46%, respectively. In the multivariate analysis, SaO2, SvO2, and retinal arteriovenous oxygen saturation difference (AVD) were significantly correlated with age (ß = 0.077, P = 0.006 for SaO2 and ß = 0.080, P = 0.006 for AVD) and SE (ß = 0.220, P < 0.001 for SaO2; ß = 0.131, P < 0.001 for SvO2; and ß = -0.050, P = 0.048 for AVD, respectively). Higher SaO2 was associated with larger K values (ß = 0.094, P = 0.001). Conclusions: SaO2 increased with older age, lower myopia, and larger K values, older age was associated with higher SaO2 and AVD, and SvO2 decreased with the deepening of myopia. Our present study provided normative values for healthy Chinese myopic adults with different myopic refractive errors.

Changes in relative peripheral refraction and optical quality in Chinese myopic patients after small incision lenticule extraction surgery.

PURPOSE: To observe changes in retinal refraction difference values (RDV) and aberrations after small incision lenticule extraction (SMILE) surgery and evaluate their correlations. METHODS: This study recruited 112 patients (112 eyes) who underwent SMILE for myopia. Participants were classified into the Low and Moderate Myopia group (LM, -0.50 to -6.0 D) and High Myopia group (HM, >-6.0 D) according to the central spherical equivalent (SE). RDVs in the five retinal eccentricities from 0° to 10°, 10° to 20°, 20° to 30°, 30° to 40°, and 40° to 53° are recorded as RDV-(0-10), RDV-(10-20), RDV-(20-30), RDV-(30-40), and RDV-(40-53), respectively; additionally, RDVs have four sectors, i.e., RDV-Superior (RDV-S), RDV-Inferior (RDV-I), RDV-Temporal (RDV-T), and RDV-Nasal (RDV-N). With a 3-month follow-up, changes in RDV (ΔRDV) and changes in aberrations [Δtrefoil, Δcoma, Δspherical aberration (SA), and Δtotal higher-order aberrations (HOA)] after surgery were recorded. RESULTS: No significant differences were observed in total RDV (TRDV), RDV-(0-53), RDV-S, RDV-I, RDV-N, trefoil, coma, and SA between the two groups before SMILE surgery. However, after SMILE, hyperopic defocus values [TRDV, RDV-(20-53), RDV-S, RDV-T, and RDV-N] in the LM group and hyperopic defocus values [TRDV, RDV-(20-53), RDV-S, and RDV-N] in the HM group were significantly lower at 3 months postoperatively than preoperatively, and the RDV-(40-53), RDV-S, and RDV-N were lower in the HM group than in the LM group. Aberrations [trefoil (vertical), coma, and HOA] in the LM group and aberrations (trefoil, coma, SA, and HOA) in the HM group were significantly higher at 3 months postoperatively than preoperatively, and the coma, trefoil(horizontal), SA, and HOA were higher in the HM group than in the LM group. In the multivariate analysis, ΔRDV-(40-53) was significantly correlated with ΔSA, and ΔRDV-T and ΔRDV-N were significantly correlated with Δcoma (horizontal). CONCLUSIONS: Our findings suggest that SMILE reduces retinal peripheral hyperopic defocus but introduces some higher-order aberrations, especially in people with high myopia refractive errors.

[Varieties systematization and standards status analysis of fermented Chinese medicine].

Fermented Chinese medicine has long been used. Amid the advance for preservation of experience, the connotation of fermented Chinese medicine has been enriched and improved. However, fermented Chinese medicine prescriptions generally contain a lot of medicinals. The fermentation process is complicated and the conventional fermentation conditions fail to be strictly controlled. In addition, the judgment of the fermentation end point is highly subjective. As a result, quality of fermented Chinese medicine is of great difference among regions and unstable. At the moment, the quality standards of fermented Chinese medicine are generally outdated and different among regions, with simple quality control methods and lacking objective safe fermentation-specific evaluation indictors. It is difficult to comprehensively evaluate and control the quality of fermented medicine. These problems have aroused concern in the industry and also affected the clinical application of fermented Chinese medicine. This article summarized and analyzed the application, quality standards, and the modernization of fermentation technology and quality control methods of fermented Chinese medicine and proposed suggestions for improving the quality standards of the medicine, with a view to improving the overall quality of it.

Retinal Vascular Oxygen Saturation in Adults With Anisometropia.

Purpose: This study aimed to examine the differences of retinal oxygen saturation between the paired eyes in anisometropia and to further explore the relation between retinal oxygenation and myopia. Methods: This was an observational cross-sectional study, with 124 adults with anisometropia included. According to the interocular differences in spherical equivalent (SE), individuals with a difference ≥3.0 D belonged to the ΔSE ≥ 3.0 D group, and those with a difference ≥1.5 D and <3.0 D belonged to the ΔSE <3.0 D group. The ΔSE ≥ 3.0 D group contained 61, and the ΔSE < 3.0 D group contained 64. All were performed examinations of retinal oximetry, SE, axial length (AL), intraocular pressure, central corneal thickness and average keratometry. Results: The median SE and AL were -5.06 (-7.22 ∼ -3.41) D and 25.54 (24.73 ∼ 26.62) mm in the "ΔSE < 3 D" group and -4.25 (-6.88 ∼ -2.09) D and 25.52 (24.49 ∼ 26.45) mm in the other group. The retinal arterial oxygen saturation (SaO2) was 93.97% ± 1.26% in the less myopic eyes and 93.18% ± 1.53% (P < 0.001) in the more myopic eyes. In multivariate analyses, SE and AL were both significantly associated with the SaO2. Conclusions: The SaO2 between anisometropic myopic eyes was different, and it was associated with SE and AL. Translational Relevance: This study demonstrates a relationship between myopia and retinal vascular oxygenation through a novel retinal oximeter.

Characterization of the high-affinity anti-CTLA-4 monoclonal antibody JS007 for immune checkpoint therapy of cancer.

Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) is a critical inhibitory checkpoint molecule, and monoclonal antibodies (mAbs) targeting CTLA-4 that restore anti-tumor T cell immunity have achieved clinical success. Here, we report a humanized IgG1 mAb, namely JS007, with high binding affinity to CTLA-4. JS007 shows superior binding affinity and T-cell activating efficiency over ipilimumab. Moreover, it demonstrates substantial in vivo tumor suppression efficacy at low doses. The crystal structure of JS007/CTLA-4 complex (PDB: 8HIT) shows JS007 adopts a heavy-chain-dominant binding mode, and mainly contacts the BC loop, DE loop and FG loop of CTLA-4. Notably, two Tyr residues (VH-Y100 and VL-Y32) from the complementarity-determining region loops insert into the two cavities formed by the residues from the loops of CTLA-4, which may contribute to the stabilization of the binding. Comparative analysis with other anti-CTLA-4 mAbs indicates that the double "wedge-into-hole" binding mode is unique for JS007 and may be responsible for the high-affinity binding to CTLA-4. These findings have provided an important molecular understanding of the high-affinity CTLA-4 blockade mAbs and shed light on future development of agents targeting CTLA-4.

[Reflections on supervision strategies of new Tibetan drug registration].

Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.

Opportunities and hurdles to European market access for multi-herbal traditional Chinese medicine products: An analysis of EU regulations for combination herbal medicinal products.

TCM herbal remedies are popular among European patients. However, a very limited number of TCM products have been approved as herbal medicinal products (HMPs) in Europe. Multi-herbal TCM products, the most prevalent form of medication in TCM practice, are even rare. This indicates multi-herbal TCM products are facing considerable obstacles in the access to EU market. To further identify such obstacles, we make a systematic analysis of current advances in both EU herbal monographs and combination HMPs granted in member states and present main features of the regulation as well as challenges for multi-herbal TCM products. The results show the EU is open to combination HMPs based on TCM or other non-European traditions. The regulation allows appropriate flexibility in the range of drug extraction rations, variation in concentrations of extraction solvent and number of herbal drugs presented in the product, if plausible pharmacological effects could be justified. Meanwhile, to guarantee the safety and efficacy based on medicinal usage, especially to justify the rationale or plausibility of the combination, is the key element for well-established use or traditional use combination HMPs. Additionally, EU herbal monographs also have great value in their marketing procedure. Nonetheless, there are many challenges in the European market access of multi-herbal TCM products which lies in quality control, safety and efficacy evaluation and others e.g., practical standard for full marketing authorization. Enforced scientific research and communication among research institutions, industries and authorities are necessary to further facilitate the access of multi-herbal TCM products to EU market. The results of this article may provide guidance for HMPs based on TCM or other non-European traditions with intention to entering EU market.

Targeted bile acid profiles reveal the liver injury amelioration of Da-Chai-Hu decoction against ANIT- and BDL-induced cholestasis.

Multiple types of liver diseases, particularly cholestatic liver diseases (CSLDs) and biliary diseases, can disturb bile acid (BA) secretion; however, BA accumulation is currently seen as an important incentive of various types of liver diseases' progression. Da-Chai-Hu decoction (DCHD) has long been used for treating cholestatic liver diseases; however, the exact mechanisms remain unclear. Currently, our study indicates that the liver damage and cholestasis status of the α-naphthylisothiocyanate (ANIT)-induced intrahepatic cholestasis and bile duct ligation (BDL)-induced extrahepatic cholestasis, following DCHD treatment, were improved; the changes of BA metabolism post-DCHD treatment were investigated by targeted metabolomics profiling by UPLC-MS/MS. DCHD treatment severely downregulated serum biochemical levels and relieved inflammation and the corresponding pathological changes including necrosis, inflammatory infiltration, ductular proliferation, and periductal fibrosis in liver tissue. The experimental results suggested that DCHD treatment altered the size, composition, and distribution of the BAs pool, led the BAs pool of the serum and liver to sharply shrink, especially TCA and TMCA, and enhanced BA secretion into the gallbladder and the excretion of BAs by the urinary and fecal pathway; the levels of BAs synthesized by the alternative pathway were increased in the liver, and the conjugation of BAs and the pathway of BA synthesis were actually affected. In conclusion, DCHD ameliorated ANIT- and BDL-induced cholestatic liver injury by reversing the disorder of BAs profile.

Post-Ortho-K Corneal Epithelium Changes in Myopic Eyes.

The study is aimed at evaluating corneal epithelial thickness changes associated with overnight orthokeratology (ortho-K). In this retrospective study, epithelial thickness was measured using optical coherence tomography (OCT) before and after 1 day, 1 week, 1 month, and 3 months ortho-K nightly lens wear. Compared with pre-orthokeratology measurements, central (2 mm) corneal epithelium thickness was significantly reduced at 1 day, 1 week, 1 month, and 3 months with ortho-K (P < 0.05). Paracentral (2 mm~5 mm annular ring) epithelial thickness was also significantly reduced at superior temporal, inferior temporal, temporal, and inferior locations after ortho-K (P < 0.05), while midperipheral (5 mm~6 mm annular ring) epithelial thickness was greater post- than pre-ortho-K at superior, superior temporal, inferior temporal, inferior, and inferior nasal locations (P < 0.05). In other zones, superior, superior nasal, nasal, and inferior nasal in paracentral annular ring and temporal and superior nasal in midperipheral ring, epithelial thickness underwent no significant change. Ortho-K lens wear caused the central corneal epitheliums to thin. The temporal half zones become thinner in paracentral zones and thicker in midperipheral zones.

Comparison of clinical outcome of small-incision lenticule intrastromal keratoplasty and FS-LASIK for correction of moderate and high hyperopia.

AIM: To compare the clinical outcome of small-incision lenticule intrastromal keratoplasty (sLIKE) and femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for correction of moderate and high hyperopia. METHODS: A case-controlled clinical study was performed. Twenty right eyes of 20 moderate and high hyperopia patients underwent sLIKE (sLIKE group) and 22 right eyes of 22 moderate and high hyperopia patients underwent FS-LASIK (FS-LASIK group) were enrolled in this study from October 2015 to October 2017. Visual acuity, refractive error, corneal thickness, and keratometry were compared between the groups before and 1y postoperatively. RESULTS: The postoperative uncorrected near visual acuity (UNVA) and uncorrected distance visual acuity (UDVA) were improved in the two groups. The UNVA reached J1 in 15 eyes (75.0%) in the sLIKE group and 5 eyes (22.7%) in the FS-LASIK group 1y after surgery (χ 2=11.476, P=0.001). The UDVA was equal or better than the preoperative CDVA in 16 eyes (80.0%) in the sLIKE group and 8 eyes (36.4%) in the FS-LASIK group, respectively (χ 2=8.145, P=0.004). No eyes lost any line of best-corrected visual acuity (BCVA) in either group. The amount of postoperative residual hyperopia in the sLIKE group was significantly less than in the FS-LASIK group (Z=-2.841, P=0.004). The postoperative keratometry and corneal thickness were significantly higher in the sLIKE group than in the FS-LASIK group (t=4.411, 10.279, P<0.001). The SRI and SAI of the sLIKE group were significantly higher than that in the FS-LASIK group. There was no statistically significant difference in mean decentration between the two groups. CONCLUSION: sLIKE has better visual and refractive outcome than FS-LASIK for correction of moderate and high hyperopia.

[Thoughts on path of R&D and registration of innovative traditional Chinese medicine with synchronous transformation of "series prescriptions"].

Since the implementation of drug registration in China, the classification of Chinese medicine has greatly met the needs of public health and effectively guided the transformation, inheritance, and innovation of research achievements on traditional Chinese medicine(TCM). In the past 30 years, the development of new Chinese medicine has followed the registration transformation model of " one prescription for single drug". This model refers to the R&D and registration system of modern drugs, and approximates to the " law-abiding" medication method in TCM clinic, while it rarely reflects the sequential therapy of syndrome differentiation and comprehensive treatment with multiple measures. In 2017, Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices released by the General Office of the CPC Central Committee and the General Office of the State Council pointed out that it is necessary to " establish and improve the registration and technical evaluation system in line with the characteristics of Chinese medicine, and handle the relationship between the traditional advantages of Chinese medicine and the requirements of modern drug research". Therefore, based on the development law and characteristics of TCM, clinical thinking should be highlighted in the current technical requirements and registration system of research and development of Chinese medicine. Based on the current situation of registration supervision of Chinese medicine and the modern drug research in China, the present study analyzed limitations and deficiency of " one prescription for single drug" in the research and development of Chinese medicine. Additionally, a new type of " series prescriptions" was proposed, which was consistent with clinical thinking and clinical reality. This study is expected to contribute to the independent innovation and high-quality development of the TCM industry.

[Current situation and problems of national standards for Chinese medicinal materials].

To learn the current situation and strengthen the management of national standards for Chinese medicinal materials, we sorted out the relevant national standards. According to incomplete statistics, there are 1 185 kinds of Chinese medicinal materials, including 1 024 kinds of plant medicines, 106 kinds of animal medicines, and 54 kinds of mineral medicines, in addition to ethnic medicinal materials with different functions. The relevant standards include 819 Pharmacopoeia standards, 342 standards issued by the Ministry of Health or National Medicinal Products Administration, 7 standards for new medicinal materials, and 17 standards for imported medicinal materials. In this paper, the sources of standards as well as the distribution of families and genera and the distribution of medicinal parts of medicinal materials are analyzed. The suggestions are as follows:(1)to improve the coordination among different national standards of Chinese medicinal materials;(2)to improve the standardization and controllability of relevant standards;(3)to revise the issued standards for Chinese medicinal materials(including Tibetan, Uygur, and Mongolian medicinal materials).

Small incision lenticule extraction (SMILE) combined with allogeneic intrastromal lenticule inlay for hyperopia with astigmatism.

PURPOSE: To quantitatively evaluate outcomes after small incision lenticule extraction (SMILE) combined with allogeneic intrastromal lenticule inlay for hyperopia with astigmatism. METHODS: It's a retrospective cohort study. Twenty-four eyes of 15 patients with more than 0.75 diopters (D) of astigmatism in hyperopic eyes were enrolled in this study. The hyperopic eye with astigmatism was first treated with SMILE to correct astigmatism; then a lenticule was extracted from a donor myopic eye and subsequently implanted into the hyperopic eye with astigmatism. Patients were examined preoperatively and 1 day, 1 week, 1,3 months and 1 year after surgery. The main outcome measures were the uncorrected and corrected distance visual acuity (UDVA and CDVA), uncorrected near visual acuity (UNVA), spherical equivalent (SE), corneal topography, anterior segment optical coherence topography (OCT) and ocular response analyzer (ORA) parameters: corneal hysteresis (CH) and corneal resistance factor (CRF). Repeated-measures analyses of variance (ANOVA) and post hoc tests were used to analyze data of different follow-up visits. RESULTS: The mean preoperative cylinder was 1.95±1.04(D). The UDVA (from 0.37±0.23 to 0.09±0.09), UNVA (from 0.49±0.21 to 0.08±0.06), SE (from +7.42±3.12 to -0.75±0.79) and astigmatism (+1.95±1.04 to -0.65±0.63) postoperatively were obviously better than those before surgery. Five eyes (26.3%) gained one line of CDVA, and 3 eyes (15.8%) gained two lines of CDVA one year after surgery compared with preoperative levels. The average corneal curvature was changed from (43.19±4.37) D to (49.19±3.87) D one year after surgery. The anterior segment OCT images of corneas with lenticule inlays at each follow-up visit showed that the implanted lenticule was shaped like a crescent in the corneal stroma. The CH and CRF didn't change significantly after surgery (p = 0.189 and p = 0.107respectively). CONCLUSIONS: SMILE combined with intrastromal lenticule inlay can be used to correct high hyperopia with astigmatism with good safety, efficacy and reproducibility.

[Research and development strategies of new Chinese medicines based on new regulations].

In recent years, only a small number of new Chinese medicines have been approved for marketing, which has embodied the bottleneck in the development of the Chinese medicine industry. To tackle this problem, the National Medical Products Administration has issued a series of regulations and technical requirements. In the context of new regulations, this study deeply explored the research and development strategies of new Chinese medicines under the guidance of the new classification of drug registration, and discussed the key technical issues in the research and development.

Evaluation of preoperative dry eye in people undergoing corneal refractive surgery to correct myopia.

AIM: To investigate the incidence of preoperative dry eye and related factors in patients undergoing corneal refractive surgery to correct myopia. METHODS: A total of 141 patients with myopia who underwent corneal refractive surgery were surveyed by questionnaires, tear film break-up time (BUT) test, Schimer I test (SIt), corneal fluorescein staining (FL) test and diagnosed according to the currently recognized domestic diagnostic criteria for dry eye. Correlation analysis of factors such as age, gender, regular wearing of contact lens (CL), diopter (spherical equivalent), corneal thickness, and corneal curvature that may affect the onset of dry eye was carried out to clarify the main influencing factors. RESULTS: There were 64 patients (45.39%) diagnosed with dry eye. The male patients (20.31%) was significantly less than that of non-dry eye subjects (41.56%; χ 2=7.260, P=0.007); the proportion of patients with dry eye wearing CL (81.25%) was significantly higher than that of non-dry eye subjects (51.95%; χ 2=13.234, P<0.001); the median diopter level of dry eye patients was -6.59 (IQR: -8.87, -4.58) D, and the median diopter level of non-dry eye subjects was -5.69 (IQR: -7.15, -4.03) D. The diopter level of dry eye patients was significantly higher (Z=-2.086, P=0.019). However, the age, best corrected visual acuity, and intraocular pressure of dry eye patients were not statistically different from those of non-dry eye subjects (t=-0.257, -0.383 and 0.778, P=0.798, 0.702, and 0.438); the corneal thickness and corneal curvature (K1 and K2) were also not statistically different either (Z=-1.487, -1.036 and -1.707, P=0.137, 0.300, and 0.088). The research further analyzes the three significant factors in the single factor analysis (gender, CL wear, and diopter) in a multi-factor way: CL wear and diopter were the influencing factors of dry eye disease. Among them, CL wear increased the risk of dry eye by 2.934 times compared with no CL wear; for every 1 D increase in diopter, the risk of dry eye increased by 0.761 times. CONCLUSION: Preoperative dry eye is relatively common in patients who undergo corneal refractive surgery to correct myopia, especially in patients who have a history of CL wear and a high diopter level before surgery. Therefore, it is necessary to carry out preoperative screening and timely treatment of dry eye to obtain the best treatment outcome and postoperative satisfaction.