Posterior Chamber Phakic Intraocular Lenses for the Correction of Myopia: Factors Influencing the Postoperative Refraction

Posterior chamber phakic intraocular lens implantation is a refractive technique for the correction of myopia. This study aimed to identify those factors contributing to variability in postoperative refraction. Methods: This retrospective study evaluated 73 eyes (one eye per patient) implanted with myopic implantable collamer lenses (ICL). Eyes were divided into two groups, the low myopic group (LMG) (ICL > −9.5 DS) and the high myopic group (HMG) (ICL ≤ −9.5 DS), to compare the predictability, efficacy index, and postoperative refraction between groups. The association of postoperative refraction with anatomical, demographic, and optical features was assessed through correlation analysis and investigated using ray-tracing. Results: Postoperative refraction at 3 months for the whole group was close to emmetropia at −0.02 ± 0.37 DS, the LMG tended toward myopia and the HMG, toward hyperopia. The results showed that 65% and 54% of the eyes had postoperative refraction of within ±0.25 DS, respectively, in the LMG and HMG, and in both groups, 100% were within ±1.00 DS. ICL implantation had a higher efficacy index in the HMG (1.13 ± 0.15) than in the LMG (1.04 ± 0.15). Postoperative refraction was positively associated with the vault (R = 0.408) and negatively correlated with ICL power (R = −0.382). Conclusion: The predictability and effectiveness of ICL implantation is high in a wide range of myopias. Considering the expected vault and including accurate vertex measurements would contribute to improving the predictability of the results.

Implantable collamer lens versus small incision lenticule extraction for high myopia correction: A systematic review and meta-analysis

Purpose To compare the efficacy, safety, predictability and visual quality between implantable collamer lens (ICL) implantation and small incision lenticule extraction (SMILE) for high myopia correction in adults. Methods A systematic review and meta-analysis was conducted. A comprehensive literature search was done based on databases including PubMed, Science Direct, Embase, and the Cochrane Central Register of Controlled Trials. The efficacy index, safety index, changes in Snellen lines of corrected distance visual acuity (CDVA), predictability (difference between post-operative and attempted spherical equivalent error, SER), incidence of halos, and change in higher-order aberrations (HOAs) were compared. Mean difference (MD) and 95% confidence interval (CI) was used to estimate continuous outcomes, risk ratio (RR) and 95%CI was used to estimate categorical outcomes. Results Five observational studies involving 555 eyes were included in this review. Studies’ sample sizes (eyes) ranged from 76 to 197. Subjects’ refraction ranged from -6 diopter (D) to -12D. Study duration of most researches were 6 months or 12 months. Compared to SMILE, ICL implantation showed better efficacy index (MD=0.09, 95%CI:0.01 to 0.16) and better safety index (MD=0.08, 95%CI: 0.00 to 0.16). Compared with SMILE, more ICL-treated eyes gained one or more Snellen lines of CDVA (RR=1.54, 95%CI:1.28 to 1.86), more gained two or more lines (RR=2.09, 95%CI:1.40 to 3.13), less lost one or more lines (RR=0.17, 95%CI:0.05 to 0.63). There was no difference in predictability between two treatments, RRs of predictability of within ±0.5D and ±1D were 1.13 (95%CI: 0.94 to 1.36) and 1.00 (95%CI: 0.98 to 1.02). Compared with SMILE, ICL implantation came with a higher risk of halos [RR=1.79, 95%CI: 1.48 to 2.16] and less increase in total HOAs (MD=-0.23, 95%CI: -0.42 to -0.03). Conclusion Compared with SMILE, ICL implantation showed a higher risk of halos, but equal performance on SER control, and better performance on efficacy index, safety index, CDVA improvement and HOAs control. Overall, ICL implantation might be a better choice for high myopia correction in adults.

COVID-19 in the Republic of Belarus: pandemic features and the interim safety and efficacy assessment of the Gam-COVID-Vac vaccine

Objective. To study the COVID-19 pandemic features among the population of the Republic of Belarus from February 2020 to September 2021 and assess the safety (tolerance) and epidemiological efficacy of the Gam-COVID-Vac vaccine (Sputnik V). Materials and methods. A retrospective analysis of COVID-19 cases in the Republic of Belarus from the beginning of registration (February 28, 2020) to September 12, 2021 was performed. To assess the COVID-19 case detection dynamics, official registration data available on the website of the Ministry of Health of the Republic of Belarus were used. Vaccine safety (tolerance) and efficacy were assessed in an observational study. Safety (tolerance) was assessed by presence/absence of adverse reactions: general and local ones. The efficacy rate (E) and the epidemiological efficacy index (K) was calculated according to the formula: E(%)=100*(b-a)/b, K=b/a. Results. Our data show that The COVID-19 pandemic in the Republic of Belarus is characterized by successive development stages: the first is the absence of COVID-19 cases in the country; the second is the registration of individual infection cases that came from abroad followed by local pathogen spread among the country's population; the third is a local spread of COVID-19 among individuals who had contact with infected people; the fourth is the detection of cases where patients had no history of exposure to COVID-19 patients. As of calendar week 26, 2021 Delta variant of SARS-CoV-2 has become the prevalent in the country. Follow-up results in January-August 2021 showed that the Sputnik V vaccine was well tolerated, with 80,832 adverse reactions reported (2.99% (95% CI 2.9-3.0) of the total number of vaccine doses administered). In terms of severity, adverse reactions were mild (91.4% (95% CI 91.2-91.6)) and moderate (8.6% (95% CI 8.6-8.8)). The epidemiological efficacy rate was 96.3%, the epidemiological efficacy index was 26.7. Thus, the results obtained testify to high prophylactic efficacy of the Sputnik V vaccine. Conclusions. The COVID-19 pandemic in the Republic of Belarus is characterized by successive development stages: from no cases in early 2020 to detected cases where most individuals had no history of contact with COVID-19 patients; periods of rising and falling incidence. The Sputnik V vaccine has demonstrated a high safety profile and epidemiological efficacy throughout mass vaccination in the Republic of Belarus.

Comparative analysis of the clinical outcomes between wavefront-guided and conventional femtosecond LASIK in myopia and myopia astigmatism

AIM: To compare the clinical outcomes of wavefront guided femtosecond LASIK (WFG LASIK) and conventional femtosecond LASIK (NWFG LASIK) in eyes with myopia and myopia astigmatism. METHODS: This was a retrospective, nonrandomized, comparative investigation enrolling 236 eyes of 122 patients (18-50y) with low & moderate and high myopia. The WFG group including 97 eyes (50 patients) undergone WFG LASIK and the NWFG group including 139 eyes (72 patients) undergone conventional LASIK. Mean efficacy index, high order aberrations (HOAs), pupil size and the quality of visual questionnaire were evaluated 6mo postoperatively. RESULTS: There is no difference between WFG group (-0.054±0.049 in logMAR) and NWFG group (-0.040±0.056) in uncorrected distance visual acuity (UDVA) postoperatively. The myopia astigmatism is higher in WFG group than that in NWFG group (P<0.05). However, the mean efficacy index (MEI) in the WFG group (1.09±0.106) is better than that in the NWFG group (1.036±0.124; P<0.001). Increased HOAs were observed in NWFG group (0.30±0.196) than that in WFG group (0.146±0.188; P<0.001). The pupil size is larger in WFG group (5.15±0.76 mm) than that in NWFG group (4.32±0.52 mm). The patients are satisfied with the clinical surgery, yet WFG group showed better visual quality using the questionnaire survey. Meanwhile, high myopia would result in worse MEI, HOAs and visual quality than low & moderate myopia. CONCLUSION: WFG and NWFG FS-LASIK are both effective and safe procedures to correct low & moderate and high myopia, but WFG FS-LASIK gives a better postoperative MEI, aberrometric control and predictable outcome. Meanwhile, WFG FS-LASIK is better than NWFG FS-LASIK in correction of myopia astigmatism. Low & moderate myopia allow better clinical outcomes than high myopia using any surgical method.

Long-term Visual Quality after Small Incision Lenticule Extraction (SMILE) and Laser Epithelial Keratomileusis (LASEK) for Low Myopia

Background: Few studies have reported the visual outcomes of small-incision lenticule extraction (SMILE) and laser-assisted epithelial keratomileusis (LASEK) for myopia correction. This study aims to compare the visual quality and corneal wavefront aberrations after SMILE and LASEK for low-myopia correction.Methods: In this prospective study, we included 29 eyes of 29 patients who received SMILE, and 23 eyes of 23 patients who received LASEK between June 2018 and January 2019. The following measurements were assessed: uncorrected (UDVA) and corrected (CDVA) distance visual acuity, manifest refraction, corneal wavefront aberrations, and subjective visual quality. All patients were followed up for two years.Results: All procedures were uneventful. An efficacy index of 1.19 ± 0.17 was established in the SMILE group and 1.23 ± 0.20 in the LASEK group. No eyes lost more than two lines of CDVA. We found that 93% (27/29) of the treated eyes in the SMILE group and 91% (21/23) in the LASEK group had spherical equivalent (SE) within ± 0.25D. The increases in the total corneal spherical aberration and the corneal front spherical aberration were lower in the SMILE group than in the LASEK group (P < 0.01). In contrast, the increases in the total corneal vertical coma and the corneal front vertical coma in the SMILE group were greater than those in the LASEK group (P < 0.01).Conclusion: Both SMILE and LASEK have good safety, stability, and patient-reported satisfaction for low myopia. SMILE induced less corneal spherical aberration but greater vertical coma than LASEK.

Efficacy Prediction of Four Pharmaceutical Formulations for Intramammary Administration Containing Aloe vera (L.) Burm. f. Combined With Ceftiofur or Cloxacillin in Lactating Cows as an Alternative Therapy to Treat Mastitis Caused by Staphylococcus aureus

Synergy or additive effect between Aloe vera (L.) Burm.f. and beta-lactam (β-lactam) antibiotics has been reported against Staphylococcus aureus, one of the most important etiological agents of cow mastitis. The goal of the present study was to predict the efficacy of intramammary formulations containing the Aloe vera gel extract in the combination with cloxacillin or ceftiofur at low concentrations in lactating cows as an alternative therapy. Each quarter of 20 healthy Holstein Friesian lactating cows were treated with a single dose of one of the following formulations, corresponding to one of these treatment groups: A1, A2, A3, and A4. A1 and A2 contained cloxacillin at 0.25 and 0.5 mg/ml, whereas A3 and A4 contained ceftiofur 0.25 and 0.5 mg/ml, respectively. In addition, all formulations contained 600 mg/ml of an alcoholic extract of Aloe vera. Milk samples were taken at predefined time points. Antibiotics and aloin (active compound of Aloe vera) concentrations were assessed by liquid chromatography mass spectrometry system (LC-MS/MS). Pharmacokinetic profiles were obtained, and the efficacy index, the fraction of dosing interval in which the antimicrobial concentration remains above the minimum inhibitory concentrations (MICs) (T &gt; MIC) for each formulation, was calculated considering MIC values against Staphylococcus aureus ATCC 29213 as obtained for the combination Aloe vera + antibiotic and aloin concentration in the extract. Mammary gland safety assessment was performed for each combination. Values of the main efficacy index for this study, T &gt; MIC (h) for Aloe vera were 23.29, 10.50, 27.50, and 13.89, whereas for cloxacillin or ceftiofur were 19.20, 10.9, 19.74, and 15.63, for A1, A2, A3, and A4, respectively. Only A1 and A3 reached aloin and antibiotic recommended values as predictors of clinical efficacy for cloxacillin, ceftiofur, and aloin (50, 70, and 60%, respectively), assuming a dose interval of 24 h. The efficacy index values obtained suggest that A1 and A3 might be an effective therapy to treat bovine mastitis caused by S. aureus after a single dose. Nevertheless, further trials in S. aureus mastitis clinical cases are mandatory to confirm the efficacy of Aloe vera formulations.

Comparative Evaluation of the Visual and Refractive Outcomes Following SMILE, FS-LASIK, and T-PRK Surgery: A Retrospective, Non-Blinded Clinical Study

Background: To comparatively evaluate of the visual and refractive outcomes after small-incision lenticule extraction (SMILE), femtosecond laser-assisted in situ keratomileusis (FS-LASIK), and transepithelial photorefractive keratectomy (T-PRK) surgery.Methods: This was a retrospective, case-series, non-blinded clinical study. Consecutive eligible patients underwent SMILE, FS-LASIK, and T-PRK at the Department of Ophthalmology of Peking Union Medical Hospital, a tertiary referral center. All myopic patients were treated with corneal refractive surgery (SMILE, FS-LASIK, and T-PRK) using the VisuMax (Carl Zeiss Meditec AG, Jena, Germany) 500-kHz femtosecond laser system and the Amaris 750S excimer laser platform (SCHWIND eye-tech solutions, Kleinostheim, Germany). Visual and topographic astigmatism changes at 6 months were the main outcome measure. Secondary outcomes were the efficacy index at 1, 3, and 6 months postoperatively.Results: We recruited 75 consecutive patients (mean age, 27.88 ± 5.76 years; 68% women; all Asian) with no significant differences between groups in terms of preoperative demographic data, except in preoperative spherical equivalent (SE) (-5.54 ± 1.86 D, -5.64 ± 1.66 D, and -3.78 ± 1.30 D, respectively; P<0.001), astigmatism (1.24 ± 1.62 D, 1.16 ± 0.75 D, and 0.72 ± 0.42 D, respectively; P=0.008), and residual bed thickness (313.08 ± 32.18 μm, 427.59 ± 30.69 μm, and 427.09 ± 41.07 μm, respectively; P<0.001). A superior efficacy index was shown in SMILE and FS-LASIK compared to T-PRK 1 month after surgery.Conclusions: The results from this retrospective, non-blind, case-series clinical study suggest that all of the corneal refractive surgery options are safe and effective. However, while SMILE and FS-LASIK procedures have equal visual outcomes, they have superior efficacy index values in the early postsurgical period.

Toric phakic IOLs in keratoconus—evaluation of preoperative parameters on the outcome of phakic anterior chamber lens implantation in patients with keratoconus

Purpose To evaluate the influence of the type of the keratectasia and preoperative keratometry readings on the efficacy of implantation of iris-fixated phakic anterior chamber intraocular lenses (pIOL) in patients with keratoconus. Methods In this retrospective study, iris-fixated pIOLs (Artisan/Artiflex (Ophtec®), Verisyse/Veriflex (AMO®)) were implanted in 38 eyes of 22 patients with stable keratoconus. Thirty-six eyes underwent corneal crosslinking (CXL) prior to the lens implantation. The refractive outcome was evaluated 6 weeks postoperatively and the influence of preoperative refraction and topo- and tomographical factors were analyzed. Results The mean postoperative uncorrected distance visual acuity (UDVApost) was 0.25 ± 0.15 logMAR and was not statistically different from the mean preoperative corrected distance visual acuity (CDVApre), which was 0.24 ± 0.13 logMAR. Twenty-seven eyes (71%) reached UDVApost/CDVApre ≥ 1 (efficacy index), whereas patients with PMD-like ectasia (n = 14) showed significantly (p = 0.003) higher efficacy index (100%) than patients diagnosed with keratoconus (n = 24) (54%). Higher eccentricity of the maximum posterior elevation showed a significant beneficial influence on the efficacy index (p = 0.021). Furthermore, a higher Amsler-Krumeich stage and preoperative MAE were correlated with a worse UDVApost. The mean absolute spherical equivalent was significantly decreased from 5.71 ± 4.96 D to 1.25 ± 1.20 D (p < 0.001). No significant difference was found in endothelial cell count. Conclusion The results indicate that the implantation of phakic iris-fixated anterior chamber IOLs is a reasonable refractive option for patients with keratoconus. Keratoconus patients with a pellucidal marginal degeneration (PMD)-like appearance ectasia seem to benefit most from such procedures.

Epi-Bowman keratectomy versus alcohol-assisted photorefractive keratectomy: wound healing and complications

Purpose: In Epi-Bowman Keratectomy™ (EBK), a new dynamic multi-blade single-use device (Epi-Clear™, Orca Surgical, Israel) is utilized to remove the epithelium by sweeping movements across the corneal surface. Epithelial cells are discarded. Alcohol or other chemical agents are not utilized. We wanted to compare clinical results of Epi-Clear photorefractive kertectomy (PRK) to alcohol-assisted PRK. Study design: Retrospective, comparative study. Methods: Consecutive case series: Adult patients seeking laser vision correction of myopia or myopic astigmatism without ocular diseases or prior surgery were included. The Epi-Clear PRK group comprised 50 consecutive eyes of 27 patients and the PRK group 50 eyes of 25 patients. Results: No intraoperative complications occurred. Epi-Clear PRK: At day 1, day 4, and 3 months, uncorrected distance visual acuity (UDVA) was 0.41/0.47/0.93 (decimal scale); epithelial defect diameter was 4.7/0.2/0 (mm); pain level was 3.8/0.3/0 (visual analogue scale, 0–10), respectively. At 3 months, efficacy index was 0.86 and spherical aberrations were unchanged. Three eyes (6%) showed (presumably sterile) infiltrates. PRK: At day 1, day 4, and 3 months, UDVA was 0.56/0.46/1.15; epithelial defect diameter was 6.3/0.2/0 (mm); pain level was 5.0/0.3/0, respectively. At 3 months, efficacy index was 1.1 and spherical aberrations were unchanged. Conclusion: The new method of epithelial debridement with Epi-Clear before laser ablation seems to offer fast epithelial removal without nicking Bowman’s layer (as observed with the laser microscope). However, we found significantly inferior results of Epi-Clear PRK compared to alcohol-assisted PRK. Furthermore, after Epi-Clear PRK corneal infiltrates as a new type of postoperative complication were observed.