Corneal Stroma Analysis and Related Ocular Manifestations in Recovered COVID-19 Patients.

Purpose: The purpose of this study was to assess the impact of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) on corneal stroma characteristics, ocular manifestations, and post-recovery refractive surgery outcomes after varying recovery durations. Methods: Fresh corneal lenticules from patients with post-coronavirus disease 2019 (COVID-19; recovered within 135 days) and healthy controls (HCs) after small incision lenticule extraction (SMILE) surgery were obtained for experimental validation of SARS-CoV-2 susceptibility, morphological changes, and immune response of the corneal stroma. Corneal optical density (CD) was measured using the Pentacam HR. Corneal epithelium thickness (ET) and endothelium parameters were evaluated by wide-field optical coherence tomography (OCT) and non-contact specular microscopy (SP-1P), respectively. All the patients were assessed after SMILE surgery until 3 month of follow-up. Results: The cornea was susceptible to SARS-CoV-2 with the presence of SARS-CoV-2 receptors (CD147 and ACE2) and spike protein remnants (4 out of 58) in post-recovery corneal lenticules. Moreover, SARS-CoV-2 infection triggered immune responses in the corneal stroma, with elevated IL-6 levels observed between 45 and 75 days post-recovery, which were then lower at around day 105. Concurrently, corneal mid-stromal nerve length and branching were initially higher in the 60D to 75D group and returned to control levels by day 135. A similar trend was observed in CD within zones 0 to 2 and 2 to 6 and in the hexagonal cells (HEX) ratio in endothelial cells, whereas ET remained consistent. Notably, these changes did not affect the efficacy, safety, or predictability of post-recovery SMILE surgery. Conclusions: SARS-CoV-2 induces temporal alterations in corneal stromal morphology and function post-recovery. These findings provided a theoretical basis for corneal health and refractive surgery management in the post-COVID-19 milieu.

SmartSight Correction of Compound Myopic Astigmatism Treatments With Preoperative Astigmatism > 1.00 Diopter Using the SCHWIND ATOS: A Retrospective Case Series.

PURPOSE: To evaluate moderate to high astigmatism corrections on the outcomes of SmartSight lenticule extraction for myopic astigmatism with a new femtosecond laser system. METHODS: Two hundred ninety-two eyes consecutively treated for myopic astigmatism with astigmatism magnitude greater than 1.00 diopter (D) were evaluated at the 6-month follow-up visit. The mean age of the patients was 29 ± 6 years with a mean spherical equivalent of -5.06 ± 2.20 diopters (D) and a mean magnitude of refractive astigmatism of 1.74 ± 0.61 D. RESULTS: At 6 months, astigmatism was 0.10 ± 0.20 D. Uncorrected and corrected distance visual acuities (UDVA and CDVA, respectively) were both 0.0 ± 0.1 logMAR. Differences between postoperative UDVA and preoperative CDVA and the change in CDVA were both +0.4 ± 0.7 lines better than preoperatively (P < .0003). CONCLUSIONS: Lenticule extraction treatment using Smart-Sight is safe and efficacious at 6 months. Findings suggest that moderate to high astigmatism improves after SmartSight lenticule extraction in the treatment of myopic astigmatism. [J Refract Surg. 2024;40(5):e328-e335.].

Comparative Study of Primary SMILE, SMILE Enhancement, and Femtosecond Laser-Assisted LASIK on Higher Order Aberrations and Corneal Densitometry.

PURPOSE: To compare differences in corneal densitometry (CD) and higher order aberrations (HOAs) in eyes that underwent small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) for the treatment of myopia and myopic astigmatism at postoperative months 3, 6, and 12, and to evaluate their changes in a separate cohort of eyes after SMILE enhancement. METHODS: In this prospective, randomized, paired-eye clinical trial, consecutive eligible participants were randomized to undergo SMILE or FS-LASIK in either eye. Main outcome measures were CD and HOAs preoperatively and at 3, 6, and 12 months postoperatively. A separate cohort of consecutive patients who had SMILE and underwent enhancement were also included for comparison. RESULTS: For CD, no significant differences were found between SMILE and FS-LASIK up to month 12. For HOA measured by wavefront aberrometry, both SMILE and FS-LASIK had an increase in total root mean square (RMS) HOAs, spherical aberration (SA), and vertical coma up to month 12. SMILE had an additional increase in vertical quatrefoil, and FS-LASIK had an increase in horizontal coma at month 12. FS-LASIK had higher SA than SMILE, whereas SMILE had higher vertical quatrefoil than FS-LASIK at month 12. Central and posterior zone CD had significantly decreased after SMILE enhancement compared to after primary SMILE up to 2 years after enhancement. RMS HOAs, lower order aberrations, and SA were all increased after SMILE enhancement compared to after primary SMILE. CONCLUSIONS: SMILE induced lower SA but higher vertical quatrefoil than FS-LASIK at 1 year. Both SMILE and FS-LASIK had similar increases in RMS HOAs and vertical coma up to 1 year. There were no differences in CD between both groups. SMILE enhancement additionally had decreased central and posterior CD but greater RMS HOAs and SA compared to primary SMILE. [J Refract Surg. 2024;40(5):e291-e303.].

Uneven Corneal Epithelial Redistribution After Femtosecond Laser-Assisted Lenticule Intrastromal Keratoplasty in Correcting Moderate-to-High Hyperopia.

PURPOSE: To evaluate the characteristic of corrective epithelial thickness after femtosecond laser-assisted lenticule intrastromal keratoplasty (LIKE) to correct moderate-to-high hyperopia. METHODS: The prospective case series study of the LIKE procedure was performed to correct moderate-to-high hyperopia. The epithelial thickness map was generated by anterior segment optical coherence tomography (AS-OCT) in the corneal central 9-mm zone. Keratometry and corneal higher order aberrations were analyzed by Pentacam (Oculus Optikgeräte GmbH) preoperatively and postoperatively. RESULTS: In the 26 eyes of 13 participants who underwent the LIKE procedure for moderate-to-high hyperopia, the attempted spherical equivalence (SEQ) was +6.50 ± 1.09 diopters (D). Compared to the preoperative epithelial thickness maps, the postoperative epithelial thickness had become significantly thinner in the central 5-mm zone; the difference was 6 to 7 µm. The paracentral epithelium performed nonuniform remodeling; the thinnest epithelial thickness was located in the inferotemporal section, which has the greatest difference from the superonasal; the difference between these two was approximately 3 µm. Through correlation analysis, it was found that the sections with thinner epithelium were significantly related to corneal curvature and corneal vertical coma. CONCLUSIONS: The LIKE procedure can be used to correct moderate-to-high hyperopia. This study further indicated the epithelial remodeling characteristic after the LIKE procedure: the central and paracentral corneal epithelial thickness becomes thinner, and the epithelial thickness distributes non-uniformly, which may be the important factor of the postoperative curvature asymmetric distribution and induction of corneal vertical coma. [J Refract Surg. 2024;40(5):e321-e327.].

In Vivo Corneal Biomechanical Response to Three Different Laser Corneal Refractive Surgeries.

PURPOSE: To compare the effects of three common refractive surgeries on corneal biomechanics. METHODS: Two hundred seven patients who had refractive surgery were included in this study, of whom 65 received transepithelial photorefractive keratectomy (tPRK), 73 received femtosecond laser-assisted laser in situ keratomileusis (FSLASIK), and 69 received small incision lenticule extraction (SMILE). Each patient had biomechanical measurements using the Corvis ST (Oculus Optikgeräte GmbH) preoperatively and at 3 and 6 months postoperatively. The measurements included five parameters expected to be associated with corneal biomechanics: deformation amplitude ratio at 2 mm (DAR2), integrated inverse radius (IIR), stiffness parameter at first applanation (SP-A1), highest concavity time (HCT), and the updated stress-strain index (SSIv2). The variations in these parameters postoperatively among the three surgeries, and their relationship with corneal thickness (CCT) and intraocular pressure measured by the Dynamic Contour Tonometer (DCT-IOP) were analyzed. RESULTS: SP-A1 decreased significantly from preoperatively to 3 months postoperatively in all three groups, whereas DAR2 and IIR increased significantly, all indicating stiffness losses. Between 3 and 6 months postoperatively, the results were inconsistent, with DAR2 decreasing (indicating stiffness increases) and IIR increasing (denoting stiffness decreases) in the FS-LASIK and SMILE groups. The decrease in SSIv2 (the only measure of corneal material stiffness) postoperatively was comparatively less pronounced at both 3 and 6 months postoperatively. On the other hand, HCT remained generally stable after all three surgeries. Unlike DAR2, IIR, and SP-A1, the changes postoperatively in stiffness parameters HCT and SSIv2 were independent of the corresponding changes in both DCT-IOP and CCT. CONCLUSIONS: Among the stiffness parameters considered, SSIv2 was not correlated with CCT or DCT-IOP, and holds promise for representing the corneal material stiffness and how it remains largely unaffected by refractive surgeries. Overall, FS-LASIK had the most significant impact on corneal stiffness, followed by SMILE, and finally tPRK. [J Refract Surg. 2024;40(5):e344-e352.].

Association of myopia and astigmatism with postoperative ocular high order aberration after small incision lenticule extraction.

OBJECTIVE: To investigate the correlation between higher-order aberrations (HOA) after small incision lenticule extraction (SMILE) and the severity of myopia and astigmatism, along with the relevant factors. These findings will provide valuable insights for decreasing the occurrence of HOA after SMILE and enhancing visual quality. METHODS: A total of 75 patients (150 eyes) with myopia and astigmatism who underwent SMILE were categorized into four groups based on the severity of myopia and astigmatism: Myopia Group 1 (Group M1, spherical diopter ranged from -1.00 D to -4.00 D), Myopia Group 2 (Group M2, spherical diopter ranged from -4.10 D to -10.00 D), Astigmatism Group 1 (Group A1, cylindrical diopter ranged from 0 D to -1.00 D), and Astigmatism Group 2 (Group A2, cylindrical diopter ranged from -1.10 D to -3.00 D). A comprehensive assessment was performed to examine the association between HOA and various relevant factors, including a detailed analysis of the subgroups. RESULTS: Group M1 had significantly lower levels of total eye coma aberration (CA), corneal total HOA (tHOA), internal tHOA, and vertical CA ( Z 3 - 1 ) after SMILE than Group M2 (P < 0.05). Similarly, Group A1 had significantly lower levels of total eye tHOA, CA, trefoil aberration (TA), corneal tHOA, TA, and vertical TA ( Z 3 - 3 ) after SMILE than Group A2 (P < 0.05). Pearson correlation analysis indicated a statistically significant positive relationship between the severity of myopia/astigmatism and most HOA (P < 0.05). Subgroup evaluations demonstrated a notable increase in postoperative HOA associated with myopia and astigmatism in Groups M2 and A2 compared with the control group. Lenticule thickness, postoperative central corneal thickness (CCT), postoperative uncorrected distance visual acuity (UDVA), and postoperative corneal Km and Cyl were strongly correlated with most HOA. Age, eyes, and postoperative intraocular pressure (IOP) were only associated with specific HOA. CONCLUSION: HOA positively correlated with the severity of myopia and astigmatism after SMILE. However, this relationship was not linear. HOA after SMILE was influenced by various factors, and additional specialized investigations are required to establish its clinical importance.

[Alternative methods of surgical treatment of keratoconus]. / Al'ternativnye metody khirurgicheskogo lecheniya keratokonusa.

The introduction of early diagnostic methods for keratoconus into clinical practice has become the basis for the development of surgical treatment techniques for this pathology, such as corneal collagen crosslinking and interlamellar keratoplasty with implantation of intrastromal segments. The article analyzes the results of research by Russian and foreign specialists in these areas and presents the data on the combination of SMILE surgery and corneal crosslinking, the Rome protocol of corneal crosslinking, modifications of interlamellar keratoplasty, the use of femtosecond laser technologies, and some pilot studies. Modern requirements for ophthalmological care require a personalized approach to each patient, and therefore the surgeon should have a wide range of surgical methods of treatment applicable to different patient cohorts. The described methods of treatment, according to the authors, are the most promising.

Interface fluid syndrome caused by the corneal perforation injury after small incision lenticule extraction: a case report.

BACKGROUND: To report a case of interface fluid syndrome (IFS) following traumatic corneal perforation repair after small incision lenticule extraction (SMILE). CASE PRESENTATION: A 23-year-old woman, with a past history of SMILE, was struck in the left eye with a barbecue prod and subsequently underwent corneal perforation repair at local hospital. Primary wound repaired with a single 10 - 0 nylon suture at the area of leakage. After the surgery, her best corrected visual acuity (BCVA) was 20/30. Four days later, she presented at our hospital with blurred vision, and interface fluid syndrome (IFS) was diagnosed. Intraoperative optical coherence tomography (iOCT) was used to guide the resuturing of the corneal perforation in the left eye, followed by anterior chamber gas injection. At the first postoperative month, the BCVA was 20/25. The corneal cap adhered closely to the stroma, the surface became smooth. CONCLUSIONS: This case illustrates that any corneal perforation following lamellar surgery, including SMILE, may lead to IFS. It is crucial to consider the depth of corneal perforation, and intraoperative optical coherence tomography (iOCT) plays a unique role in the repair procedure.

Clinical outcomes of epithelial basement membrane dystrophy after keratorefractive lenticule extraction.

PURPOSE: To determine the clinical outcomes of keratorefractive lenticule extraction (KLEx) in eyes with epithelial basement membrane dystrophy (EBMD) that developed after surgery. SETTING: Onnuri Smile Eye Clinic, Seoul, South Korea. DESIGN: Retrospective single-center study. METHODS: This study reviewed the medical records of 26 eyes of 16 patients who exhibited signs of EBMD after KLEx. Postoperatively, corneal findings and visual outcomes were evaluated. Statistical analyses were also performed on eyes without corneal complications after KLEx. RESULTS: Signs of EBMD were first observed within 1 week postoperatively in 22 eyes (84.6%): 6 eyes (23.1%) showed epithelial defects, 10 eyes (38.5%) showed subepithelial corneal opacity, 5 eyes (19.2%) showed diffuse lamellar keratitis, and 1 eye (3.9%) showed epithelial ingrowth. Symptoms such as pain, while corneal lesions were present, occurred in 21 eyes (80.8%). At 3 months postoperatively, 21 eyes (80.8%) showed no specific findings on slitlamp microscopy after medical treatment, 2 eyes (7.7%) showed subepithelial corneal opacity, 2 eyes (7.7%) showed corneal scar, and 1 eye (3.9%) showed epithelial ingrowth. Uncorrected distance visual acuity was 20/25 or better in 24 eyes (92.3%), and spherical equivalent was within ±1.0 D in 20 eyes (76.9%). The efficacy index of the EBMD group did not significantly differ from the control group, while the safety index was significantly lower. CONCLUSIONS: Manifestations of EBMD can occur after KLEx and can affect clinical outcomes. Most cases showed favorable results with appropriate nonsurgical treatment; however, some cases had long-term complications such as corneal scarring.

Comparison of refractive surgeries (SMILE, LASIK, and PRK) with and without corneal crosslinking: systematic review and meta-analysis.

Corneal crosslinking (CXL) is used for treating keratoconus and post-laser in situ keratomileusis ectasia. However, refractive surgery is not usually performed with prophylactic CXL. Therefore, we performed a meta-analysis comparing outcomes of refractive surgeries with vs without prophylactic CXL. We systematically searched databases for studies comparing refractive surgeries for myopic correction with vs without prophylactic corneal crosslinking. Review Manager 5.4.1 was used to perform statistical analysis. We included 2820 eyes from 28 studies. Compared with refractive surgery alone, surgery with prophylactic CXL resulted in decreased central corneal thickness, corrected distance visual acuity logMAR, and safety and efficacy indices. There were no significant differences in postoperative uncorrected distance visual acuity of 20/20 or better at ≥12 months and other visual outcomes among both groups. More randomized controlled trials with standard crosslinking protocols are needed to analyze the prophylactic use of crosslinking with refractive surgeries.

Ten-year outcomes following small incision lenticule extraction for up to -10Dioptres myopia.

CLINICAL RELEVANCE: More than 6 million small-incision lenticule extraction (SMILE) procedures have been performed worldwide since 2011. Therefore, its long-term safety and efficacy should be investigated. BACKGROUND: This study aimed to evaluate 10-year refractive outcomes, corneal stability, axial length, and wavefront aberrations in patients who underwent SMILE to correct myopia. METHODS: Thirty two patients (32 eyes) who underwent SMILE-based myopic correction. Corrected distance visual acuity, uncorrected distance visual acuity, corneal stability, axial length, and wavefront aberrations were evaluated preoperatively and at 1 month and 1, 5, and 10 years postoperatively. RESULTS: At 10 years postoperatively, the safety and efficacy indices for the patients included in this study were 1.19 ± 0.21 and 1.04 ± 0.27, respectively. For 26 (81%) and 30 eyes (94%), correction to within ±0.50 D and ±1.00 D of the target was achieved, respectively. Over the 10-year follow-up duration, a mean -0.32 ± 0.56 D regression was observed (-0.03 ± 0.06 D/year). Relative to baseline, horizontal and vertical comas significantly increased, as did the incidence of higher-order aberrations (all P < 0.001), whereas axial length and corneal elevation remained stable during follow-up. CONCLUSION: These results indicate that the SMILE-based correction for myopia of up to -10 Dioptres is safe, effective, and stable, with relatively constant wavefront aberrations and corneal stability over time after treatment.

Predictability of the Achieved Lenticule Thickness in Keratorefractive Lenticule Extraction for Myopia Correction.

PURPOSE: To assess the predictability between the SCHWIND ATOS femtosecond laser (SCHWIND eye-tech-solutions) read-out and achieved lenticule thickness measured using MS-39 anterior segment optical coherence tomography (ASOCT; CSO) at the corneal vertex at postoperative 1 day and 1 and 3 months of follow-up. METHODS: This retrospective case series included 130 eyes of 65 consecutive patients who were treated with SmartSight (SCHWIND eye-tech-solutions) lenticule extraction. Sixty-four percent of patients were women with a mean spherical refraction of -4.98 ± 1.19 diopters (D) and mean astigmatism of 0.53 ± 0.64 D. The measurements were performed using AS-OCT with the Phoenix Software v 4.1.1.5. Lenticule thickness was obtained by the subtraction method between preoperative and postoperative total corneal thickness. RESULTS: A lower reduction in central corneal thickness (CCT) compared to the laser read-out for all three follow-up visits can be observed. Essentially, the reduction in CCT was identical at 3 months versus 1 month. The reduction in CCT was lowest at postoperative 1 day. Examining the 1- and 3-month data (essentially equivalent), one can see a best fit of y = 0.94 x -7 µm. CONCLUSIONS: The reduction in CCT was stable from 1 month of follow-up. The stable reduction in CCT was -6% (-1.5% after accounting for design decisions) and -7 µm lower than the respective laser read-out. The findings are predictable, showing a certain level of the lenticules becoming slightly thinner than their respective laser read-outs. [J Refract Surg. 2023;39(11):728-735.].

Corneal remodeling after SMILE for moderate and high myopia: short-term assessment of spatial changes in corneal volume and thickness.

PURPOSE: To evaluate the early corneal remodeling and its influencing factors after Small incision lenticule extraction (SMILE) for moderate and high myopia. METHODS: This was a retrospective study. Pre- and post-operative (1 week and 1, 3, 6 months) corneal volume (CV), mean keratometry (Km), and corneal thickness (CT) were measured by Scheimpflug tomography. CT at the central, thinnest point, and on concentric circles of 2, 4, and 6 mm diameter was recorded to assess corneal thickness spatial profile (CTSP) and percentage of thickness increase (PTI) in the moderate and high myopia groups, and to explore possible influencing factors. RESULTS: After SMILE, the peripheral CT decreased in the moderate myopia group and central corneal thickness (CCT) increased in the high myopia group at 1 month compared to 1 week (all P < 0.05). The CV, Km and CT were significantly increased at 3 months compared to 1 month (all P < 0.05), but there was no significant change at 6 months compared to 3 months for both groups (all P > 0.05). Patients with high myopia showed greater corneal thickness changes (△CT) and higher PTI than moderate myopia (all P < 0.05). Regression analysis revealed that in addition to refraction, peripheral PTI was negatively correlated with CCT in the moderate myopia group (4 mm: ß = -0.023, P = 0.001; 6 mm: ß = -0.050, P < 0.001), as well as in the high myopia group (4 mm: ß = -0.038, P < 0.001; 6 mm: ß = -0.094, P < 0.001). Moreover, peripheral PTI in the moderate myopia group was negatively correlated with age (4 mm: ß = -0.071, P = 0.003; 6 mm: ß = -0.162, P < 0.001). CONCLUSIONS: After SMILE, the CV, Km, and CTSP showed dynamic changes in the early stage, which stabilized after 3 months. Compared to the moderate myopia group, the high myopia group experienced slower corneal stabilization. The change in PTI at 6 months after SMILE may be related to higher preoperative refraction, thinner CCT and younger age.

Central corneal distortion after small-incision lenticule extraction.

A 33-year-old woman with a prior history of small-incision lenticule extraction (SMILE) presented with gradual deterioration of vision in her right eye since the surgery. She had undergone bilateral SMILE for myopic correction (-7.00 diopters [D] in the right eye and -6.00 D in the left eye) 3 weeks prior. SMILE was performed with a Zeiss VisuMax femtosecond laser system, with a cap thickness of 120 µm, a cap diameter of 7.50 mm, and a lenticule diameter of 6.50 mm. At the completion of the surgery, loose epithelium was noted at the SMILE incision bilaterally, and bandage contact lenses were placed in both eyes. On the first postoperative day, the patient's uncorrected distance visual acuity (UDVA) was 20/40 in both eyes. The bandage lenses were removed from both eyes, with the epithelium intact. At the first-week postoperative visit, her visual acuity was recorded as 20/30 in the right eye and 20/20 in the left eye. She noticed her vision in the right eye was not as sharp as that in her left eye. She denied experiencing any pain, redness, or ocular surface irritations. She was advised to return to the clinic for a 1-month postoperative visit and continue with aggressive lubrication in both eyes. However, a week later, the patient returned for an emergency visit, citing significant central visual distortion in the right eye and difficulty working on the computer. At this visit, her UDVA and corrected distance visual acuity (CDVA) was 20/50 in the right eye and 20/15 in the left eye at both near and far distances. A slitlamp examination revealed mild central changes in the right eye. She once again denied any pain, redness, or irritation. She was advised to continue with artificial tears and return to the office in 1 week for further observation of the central distortion in her right eye. Upon returning to the clinic at the third postoperative week, the patient still complained of central visual changes in the right eye, with a visual acuity of 20/70. Further slitlamp examination revealed a nonspecific central haze in the same eye, but there was no corneal staining or signs of epithelial defects. Anterior segment ocular coherence tomography (AS-OCT) and NIDEK topography were performed, showing the same central distortion in the right eye (Figures 1 and 2JOURNAL/jcrs/04.03/02158034-202311000-00016/figure1/v/2023-10-18T004638Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202311000-00016/figure2/v/2023-10-18T004638Z/r/image-tiff). Based on the examination and images provided, what is your working medical diagnosis? What other medical conditions are in your differential diagnosis? What medical and/or surgical interventions would you recommend, if any?

Electron beam-irradiated donor cornea for on-demand lenticule implantation to treat corneal diseases and refractive error.

The cornea is the major contributor to the refractive power of the eye, and corneal diseases are a leading cause of reversible blindness. The main treatment for advanced corneal disease is keratoplasty: allograft transplantation of the cornea. Examples include lenticule implantation to treat corneal disorders (e.g. keratoconus) or correct refractive errors. These procedures are limited by the shelf-life of the corneal tissue, which must be discarded within 2-4 weeks. Electron-beam irradiation is an emerging sterilisation technique, which extends this shelf life to 2 years. Here, we produced lenticules from fresh and electron-beam (E-beam) irradiated corneas to establish a new source of tissue for lenticule implantation. In vitro, in vivo, and ex vivo experiments were conducted to compare fresh and E-beam-irradiated lenticules. Results were similar in terms of cutting accuracy, ultrastructure, optical transparency, ease of extraction and transplantation, resilience to mechanical handling, biocompatibility, and post-transplant wound healing process. Two main differences were noted. First, ∼59% reduction of glycosaminoglycans resulted in greater compression of E-beam-irradiated lenticules post-transplant, likely due to reduced corneal hydration-this appeared to affect keratometry after implantation. Cutting a thicker lenticule would be required to ameliorate the difference in refraction. Second, E-beam-sterilised lenticules exhibited lower Young's modulus which may indicate greater care with handling, although no damage or perforation was caused in our procedures. In summary, E-beam-irradiated corneas are a viable source of tissue for stromal lenticules, and may facilitate on-demand lenticule implantation to treat a wide range of corneal diseases. Our study suggested that its applications in human patients are warranted. STATEMENT OF SIGNIFICANCE: Corneal blindness affects over six million patients worldwide. For patients requiring corneal transplantation, current cadaver-based procedures are limited by the short shelf-life of donor tissue. Electron-beam (E-beam) sterilisation extends this shelf-life from weeks to years but there are few published studies of its use. We demonstrated that E-beam-irradiated corneas are a viable source of lenticules for implantation. We conducted in vitro, in vivo, and ex vivo comparisons of E-beam and fresh corneal lenticules. The only differences exhibited by E-beam-treated lenticules were reduced expression of glycosaminoglycans, resulting in greater tissue compression and lower refraction suggesting that a thicker cut is required to achieve the same optical and refractive outcome; and lower Young's modulus indicating extra care with handling.

An Efficient Technique for the Long-term Preservation of SMILE Lenticules Using Desiccation.

PURPOSE: To evaluate a desiccation protocol for the long-term preservation of human small incision lenticule extraction (SMILE) lenticules and to study their integration in an in vivo rabbit model. METHODS: Lenticules were retrieved after SMILE procedures in patients, then desiccated according to a novel protocol. Histologic and electron microscopic analyses were performed. Six rabbit eyes received grafts with an inlay technique, which consisted of inserting a desiccated lenticule into a stromal pocket. Rabbits were killed at different times between 6 and 24 weeks. Rabbit corneas were analyzed using optical coherence tomography, histology, and DAPI staining. RESULTS: Microscopic analysis of desiccated lenticules showed a preserved stromal architecture after rehydration. A decellularization of the lenticules after desiccation was observed without any chemical treatment. All rabbit corneas remained clear after grafting human lenticules and no rejection occurred. Optical coherence tomography showed regular lenticular implantation and no decrease in lenticule thickness. Histologic analysis showed no inflammatory infiltration around lenticules and no nuclear material inside lenticules after 6 months. CONCLUSIONS: A favorable integration of desiccated human SMILE lenticules in rabbit corneas was observed. The refractive issue of lenticular implantation must be investigated next. Clinical trials are needed to evaluate the use of desiccated SMILE lenticules to treat hyperopia or keratoconus in humans. [J Refract Surg. 2023;39(7):491-498.].

Subjective patient-reported visual quality after small-incision lenticule extraction and its correlation to the objective one.

PURPOSE: The purpose of the study was to characterize the subjective visual quality and satisfaction following small-incision lenticule extraction (SMILE) and to identify its influential factors. SETTING: Peking University Third Hospital, Beijing, China. DESIGN: This was a retrospective observational study. METHODS: Patients who had simultaneous binocular SMILE for myopia and myopic astigmatism were included 6 months postoperatively, and the patient-reported outcome questionnaire was employed for the assessment of visual quality in real-life situations. Examinations with SIRIUS combined corneal topography and tomography were performed including the parameters of Strehl ratio (SR), corneal higher-order aberrations (HOAs) within 6.0-mm area, kappa angel, and thinnest corneal thickness. Decentration and effective optical zone (EOZ) were measured based on a tangential pre-post-operation difference map. Binary logistic regression analysis was performed for predictors of patient-reported visual quality. RESULTS: Clinical data from 97 cases were analyzed retrospectively. Overall satisfaction was 96.91% (94/97). Fluctuation in vision and glare is the most frequent and dominant visual symptoms. SR value increased non-significantly compared with preoperative (P> 0.05). A statistically significant (P < 0.05) increase in total HOAs, spherical aberration, and coma was noted. SR and HOAs were not correlated with the degree of visual symptoms (P > 0.05). No objective parameter was found to be associated with patient-reported visual quality after SMILE (P> 0.05). CONCLUSION: The high patient-reported satisfaction confirmed the ideal effect on visual quality following SMILE in real-life situations, though some objective optical performances were not satisfying. It is very tolerant toward patients' conditions and mild deviations, and this study did not find factors affecting visual performances.

Comparative analysis of visual outcomes following small-incision lenticule extraction with or without cyclotorsion compensation in eyes with high astigmatism: Contralateral eye study.

Purpose: To compare the visual outcomes in patients undergoing small-incision lenticule extraction (SMILE) for correction of myopic astigmatism (≥-1.50 D) with or without manual cyclotorsion compensation. Methods: A prospective, double-blinded, randomized, contralateral study was conducted in the refractive services of a tertiary eye care center. Eligible patients with bilateral high myopic astigmatism (≥1.5 D) and intraoperative cyclotorsion (≥5°) undergoing SMILE between June 2018 and May 2019 were included. Cyclotorsion compensation was performed using triple centration method before femtosecond laser delivery. Uncorrected and corrected distance visual acuity (UDVA and CDVA, respectively) measurement, manifest refraction, slit-lamp biomicroscopy, and corneal tomography were performed preoperatively and at 1 and 3 months' postoperative visit. Astigmatic outcomes were analyzed using Alpins criteria. Results: A total of 30 patients (60 eyes) were included in this study. The patients underwent bilateral SMILE surgery, with manual cyclotorsion compensation in one eye (CC group, n = 30 eyes) and no cyclotorsion compensation in the other eye (NCC group, n = 30 eyes). Preoperative astigmatism and intraoperative cyclotorsion were -2.0 D and 7.03° ± 1.06° (CC) and -1.75 D and 7.24° ± 0.98° (NCC) (P = 0.472 and 0.240, respectively). No significant differences were noted in mean refractive spherical equivalent (MRSE), UDVA, CDVA, and refractive error between the two groups at 3 months' postoperative visit. Astigmatic outcomes measured using Alpins criteria demonstrated no significant difference between the two cohorts. Conclusion: The cyclotorsion compensation technique provided no additional advantage in terms of astigmatic outcomes or postoperative visual quality, in eyes with high preoperative astigmatism and intraoperative cyclotorsion.

Higher-order aberrations and visual quality after incision lenticule extraction surgery with intraoperative angle kappa adjustments between small and large kappa patients: A 2-year follow-up.

Purpose: To evaluate the postoperative visual outcomes, that is, corneal higher-order aberrations (HOAs) and visual quality, of patients with an angle kappa greater than 0.30 mm who underwent angle kappa adjustment during small-incision lenticule extraction (SMILE) 2 years after surgery compared to eyes with an angle kappa less than 0.30 mm. Methods: This was a retrospective study and included 12 patients from October 2019 to December 2019 who underwent the SMILE procedure for correction of myopia and myopic astigmatism and had one eye with a large kappa angle and another eye with a small kappa angle. Twenty-four months after surgery, an optical quality analysis system (OQAS II; Visiometrics, Terrassa, Spain) was used to measure the modulation transfer function cutoff frequency (MTFcutoff), Strehl2D ratio, and objective scatter index (OSI). HOAs were measured with a Tracey iTrace Visual Function Analyzer (Tracey version 6.1.0; Tracey Technologies, Houston, TX, USA). Assessment of subjective visual quality was achieved using the quality of vision (QOV) questionnaire. Results: At 24 months postoperatively, the mean spherical equivalent (SE) refraction was - 0.32 ± 0.40 and - 0.31 ± 0.35 in the S-kappa group (kappa <0.3 mm) and the L-kappa group (kappa ≥0.3 mm), respectively (P > 0.05). The mean OSI was 0.73 ± 0.32 and 0.81 ± 0.47, respectively (P > 0.05). There was no significant difference in MTFcutoff and Strehl2D ratio between the two groups (P > 0.05). Total HOA, coma, spherical, trefoil, and secondary astigmatism were not significantly different (P > 0.05) between the two groups. Conclusion: Adjustment of angle kappa during SMILE helps reduce the decentration, results in less HOAs, and promotes visual quality. It provides a reliable method to optimize the treatment concentration in SMILE.

Refractive Outcome After Corneal Lenticule Implantation Ex Vivo Non-Human Study.

PURPOSE: To evaluate changes in corneal refractive parameters after implantation of a stromal lenticule of different thickness. We assume that the refractive outcome depends on the optical power of the used lenticule. METHODS: We conducted an ex-vivo non-human study on 33 normotonic porcine eyeballs divided into two groups, for 4D and 8D human lenticule implantation. Corneal stromal lenticules were obtained as a by-product from a laser procedure ReLEx SMILE. We evaluated corneal refractive parameters measured on Oculus Pentacam© device before and immediately after the intrastromal lenticule implantation. RESULTS: There was no statistically significant difference in corneal refractive parameters between the eyeball groups before lenticule implantation. In both groups, the intrastromal implantation in the depth of 300um led to a significant increase of central corneal pachymetry and corneal anterior steepening. In the 4D group the average central corneal pachymetry increased from 903 ± 124.59 to 1230 ± 148.99 (p = 0.0022) and in 8D group from 733.35 ± 69.60 to 1109 ± 161.64 (p = 0.0008). Induced changes in other studied parameters were not statistically significant, Kmax changed from 45.57 ± 2.78 to 72.07 ± 16.83 (p = 0.0094) and Km front from 40.72 ± 1.60 to 48.87 ± 5.83 (p = 0.0037) in 4D group and in the 8D group average Kmax increased from 42.22 ± 1.54 to 62.95 ± 12.67 (p = 0.0001) and K2 front 40.46 ± 1.64 to 51.51 ± 9.63 (p = 0.0037). There were no significant differences in refractive changes between the 4D and 8D groups after lenticule implantation. CONCLUSION: Intrastromal corneal lenticule implantation induces changes in corneal refractive parameters. In both groups, the implantation induced a significant increase of an anterior corneal steepening without any significant influence on posterior corneal flattening. Corneal lenticule implantation did not lead to any significant change of corneal astigmatism. However, in order to have more precise data for future clinical applications we need to continue with the experiments and verify the results on human corneas.