Randomized, Multicenter Study to Assess the Effects of Different Doses of Sildenafil on Mortality in Adults With Pulmonary Arterial Hypertension.

BACKGROUND: Sildenafil, approved for pulmonary arterial hypertension (PAH), has a recommended adult dose of 20 mg TID, with a previously approved 5-mg TID dose by the US Food and Drug Administration. Safety concerns arose because of common off-label use of higher doses, particularly after pediatric data linked higher doses to increased mortality. To assess this, the Food and Drug Administration mandated a study evaluating the effects of various sildenafil doses on mortality in adults with PAH. METHODS: This randomized, double-blind study compared sildenafil at doses of 5, 20, or 80 mg TID in adults with PAH. The primary objective was noninferiority of 80 mg of sildenafil versus 5 mg for all-cause mortality. Secondary end points included time to clinical worsening and change in 6-minute walk distance at 6 months. Interim analyses were planned at 50% and 75% of the anticipated mortality events. Safety and tolerability were assessed in the intention-to-treat population. RESULTS: The study was halted after the first interim analysis, demonstrating noninferiority for 80 mg of sildenafil versus 5 mg. Of 385 patients enrolled across all dose groups, 78 died. The primary analysis showed a hazard ratio of 0.51 (99.7% CI, 0.22-1.21; P<0.001 for noninferiority) for overall survival comparing 80 mg of sildenafil with 5 mg. Time to clinical worsening favored 80 mg of sildenafil compared with 5 mg (hazard ratio, 0.44 [99.7% CI, 0.22-0.89]; P<0.001). Sildenafil at 80 mg improved 6-minute walk distance from baseline at 6 months compared with 5 mg (least square mean change, 18.9 m [95% CI, 2.99-34.86]; P=0.0201). No significant differences were found between 80 mg of sildenafil and 20 mg in mortality, clinical worsening, and 6-minute walk distance. Adverse event-related drug discontinuations were numerically higher with 80 mg of sildenafil. CONCLUSIONS: Sildenafil at 80 mg was noninferior to sildenafil at 5 mg when examining all-cause mortality in adults with PAH. Secondary efficacy end points favored 80 mg of sildenafil over 5 mg. On the basis of these findings, the Food and Drug Administration recently revoked the approval of 5 mg of sildenafil for adults with PAH, reinforced 20 mg TID as the recommended dose, and now allows dose titration up to 80 mg TID, if needed. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02060487.

LONG-TERM USE OF ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.

PURPOSE: Although pivotal trials have demonstrated efficacy of anti-vascular endothelial growth factor therapy in neovascular age-related macular degeneration, there is a paucity of clinical data about the long-term (>5 years) treatment. METHODS: Retrospective analysis of all patients with neovascular age-related macular degeneration who were actively treated, had received >40 anti-vascular endothelial growth factor injections, and were followed for ≥5 years. Snellen-corrected visual acuity, initial drug choice, and times elapsed between treatments were collected. Rates of endophthalmitis and outcomes of submacular hemorrhage were also evaluated. RESULTS: A total of 88 patients (162 eyes) met the inclusion criteria: the average patient age was 86.3 years with an average follow-up period of 7.6 years. The average total number of injections per eye was 69 (18.0 SD); a total of 11,208 injections were given throughout the study period, and 6 cases (0.05%) of endophthalmitis were observed. Overall, there was a clinical and statistical difference in average Snellen-corrected visual acuity at Injections #2,#3, #4, #5, #6, #10, and #20, as compared with baseline ( P = 0.03, P < 0.01, P = 0.02, P < 0.01, P = 0.01, P = 0.01, P < 0.01, respectively). Patients in the Snellen-corrected visual acuity subgroup 20/20 to 20/40 maintained vision until injection #30. Seven eyes experienced a visually significant submacular hemorrhage. CONCLUSION: This neovascular age-related macular degeneration cohort received on average eight anti-vascular endothelial growth factor injections per year for approximately 8 years; eyes with good (≥20/40) initial baseline vision maintained their visual acuity, whereas those with worse Snellen-corrected visual acuity (≤20/50) had a robust initial improvement that diminished with time. Most patients were maintained on the same initial drug of choice and the rate of endophthalmitis was low.

Does Primary Cleft Palate Repair by Furlow Z-Plasty Technique With a Buccinator Myomucosal Flap Change Speech and Middle Ear Outcomes?

BACKGROUND: Children with repaired cleft lip and palate may present with middle ear effusion and disturbed speech due to velopharyngeal (VP) insufficiency. Furlow Z-palatoplasty with a buccinator myomucosal flap is one of the effective surgical techniques for primary cleft palate repair and lengthening of the palate. PURPOSE OF THE STUDY: This study aimed to evaluate the effect of Furlow Z-palatoplasty with buccal myomucosal flap as a primary cleft palate repair technique on the VP function during speech and the Eustachian tube function. MATERIALS AND METHODS: Forty patients with non-syndromic cleft lip and palate aged 3 to 7 years surgically repaired with Furlow palatoplasty with a buccinator myomucosal flap were assessed. Perceptual speech assessment, nasopharyngoscopic examination, otoscopic examination, and tympanometry were done for all patients to assess the speech and middle ear function. RESULTS: The percentage of mild hypernasality was significant in 22.5% of children with repaired cleft lip and palate, while 77.5% showed no hypernasality. Speech intelligibility was normal in 77.5% and mildly affected in 22.5% of children with repaired cleft palate. Compensatory misarticulations were recorded in 12.5% of children. Nasopharyngoscopic examination revealed adequate VP closure in 75% of children with repaired cleft palate. Twenty-five percent of children with repaired cleft lip and palate had middle ear effusion and required myringotomy with insertion of tympanostomy tubes. CONCLUSION: Primary cleft palate repair with Furlow Z-palatoplasty with buccal myomucosal flap had beneficial effects on speech outcomes. It was associated with a low prevalence of middle ear effusion, and a low number of tympanostomy tubes were needed.

Treatment of anterior knee pain due to chondromalacia patellae with platelet-rich plasma and hyaluronic acid in young and middle-aged adults, a cohort study.

INTRODUCTION: Anterior knee pain commonly affects young women resulting in the declination of the quality of life. One of the possible pathologies causing this symptom is chondromalacia patellae (CMP). Although CMP is used to describe the softening of patellar articular cartilage, it remains a general descriptive term as it cannot be associated with a specific pathophysiologic mechanism. The objective of this study is to investigate the effect of injectable PRP on patients with anterior knee pain in absence of altered patellofemoral joint anatomy. METHODS: For this purpose, 43 patients of the affected population were recruited to participate in this non-randomized controlled trial, 28 patients in the injection group and 15 in the only-physiotherapy group. While patients in the experimental group received three PRP injections and one injection of hyaluronic acid (HA), comparators received the standard physical therapy regimen. The treatment choice was based on patients own decree. Patients between the ages of 18 to 50 years with anterior knee pain and positive Clarke´s sign were eligible for inclusion. Patients with evident anatomical abnormalities, chronic conditions affecting the knee and severe symptoms such as blocking, were excluded from the study. Patient related measures (PROMS) in the form of the VAS and the Kujala scores were the main outcome of interest. All outcomes were measured at baseline, and after 3 and 6 months after the treatment. RESULTS: Although an improvement was seen in both groups, a statistically significant difference favoring the injection of PRP over the physiotherapy-only group was observed (p < 0.001). The superiority of the therapeutic modality under investigation was observed at 3 and 6 months after the initial diagnosis was made. Furthermore, the results of this study revealed a significant improvement at 3 and 6 months when compared to baseline measures. The analysis of the patients age showed a negative correlation when baseline values were compared to measures at 3 and 6 months, meaning younger patients had more benefit from the treatment. DISCUSSION: The main results of this study affirm the positive effects of PRP and HA for the treatment of anterior knee pain described by previous research and the subsequent improvement of the quality of life. Relatively little information was found in the literature search regarding the therapeutic effects of PRP on anterior knee pain and chondropathies. While a previous radiologic study found no evidence regarding the effect of PRP, this study found a benefit when comparing PROMs between patient groups.

Evaluating the Reliability of MyotonPro in Assessing Muscle Properties: A Systematic Review of Diagnostic Test Accuracy.

Background and Objectives: Muscle properties are critical for performance and injury risk, with changes occurring due to physical exertion, aging, and neurological conditions. The MyotonPro device offers a non-invasive method to comprehensively assess muscle biomechanical properties. This systematic review evaluates the reliability of MyotonPro across various muscles for diagnostic purposes. Materials and Methods: Following PRISMA guidelines, a comprehensive literature search was conducted in Medline (PubMed), Ovid (Med), Epistemonikos, Embase, Cochrane Library, Clinical trials.gov, and the WHO International Clinical Trials platform. Studies assessing the reliability of MyotonPro across different muscles were included. A methodological quality assessment was performed using established tools, and reviewers independently conducted data extraction. Statistical analysis involved summarizing intra-rater and inter-rater reliability measures across muscles. Results: A total of 48 studies assessing 31 muscles were included in the systematic review. The intra-rater and inter-rater reliability were consistently high for parameters such as frequency and stiffness in muscles of the lower and upper extremities, as well as other muscle groups. Despite methodological heterogeneity and limited data on specific parameters, MyotonPro demonstrated promising reliability for diagnostic purposes across diverse patient populations. Conclusions: The findings suggest the potential of MyotonPro in clinical assessments for accurate diagnosis, treatment planning, and monitoring of muscle properties. Further research is needed to address limitations and enhance the applicability of MyotonPro in clinical practice. Reliable muscle assessments are crucial for optimizing treatment outcomes and improving patient care in various healthcare settings.

RETINAL VASCULITIS OR VASCULAR OCCLUSION AFTER BROLUCIZUMAB FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Systematic Review of Real-World Evidence.

PURPOSE: Retinal vasculitis or vascular occlusion (RV/RO) have been reported after brolucizumab for neovascular age-related macular degeneration. This systematic literature review evaluated RV/RO events after brolucizumab in real-world practice. METHODS: Systematic literature searches identified 89 publications; 19 were included. RESULTS: Publications described 63 patients (70 eyes) with an RV/RO event following brolucizumab. Mean age was 77.6 years and 77.8% of patients were women; 32 eyes (45.7%) received one brolucizumab injection before RV/RO. Mean (range) time to event from last brolucizumab injection was 19.4 (0-63) days, with 87.5% of events occurring within 30 days. Among eyes with preevent and postevent visual acuity (VA) assessments, 22/42 eyes (52.4%) showed unchanged (±0.08 logMAR) or improved vision from last recorded preevent assessment at latest follow-up, whereas 15/42 eyes (35.7%) showed ≥0.30 logMAR (≥15 letters) VA reduction. Patients with no VA loss were on average slightly younger and had a higher proportion of nonocclusive events. CONCLUSION: Most RV/RO events reported after brolucizumab in early real-world practice occurred in women. Among eyes with VA measurements, approximately half experienced VA loss; overall, about one-third had VA reduction of ≥0.30 logMAR at latest follow-up, with indications of regional variations.

27-GAUGE PARS PLANA/PLICATA VITRECTOMY FOR PEDIATRIC VITREORETINAL SURGERY.

PURPOSE: To report on the feasibility of 27-gauge (G) vitrectomy for pediatric patients. METHODS: This study is an international, multicenter, retrospective, interventional case series. Participants were patients 17 years or younger who underwent 27-G vitrectomy for various indications. RESULTS: The records of 56 eyes from 47 patients were reviewed. Mean age was 5.7 ± 5.2 years. Diagnoses included retinopathy of prematurity (Stages 3 with vitreous hemorrhage, 4A, 4B, and 5), Terson's syndrome, traumatic macular hole, posterior capsular opacification, endophthalmitis, and others. Instruments used were the 27-G infusion, 27-G vitreous cutter, 27-G light pipe, and 27-G internal limiting membrane forceps. Instrument bending was noted in one (1.8%) case. There were no cases with intraoperative complications, infusion issues, or postoperative endophthalmitis. There were 67/145 (46%) sclerotomies that required suturing, of which most (51/145) were sutured out of precaution. There were four cases (7.1%) that required conversion to a larger gauge and three cases (5.3%) that developed postoperative hypotony. Mean visual acuity improved from logarithm of the minimum angle of resolution 1.32 (20/420) to 0.72 (20/105), after a mean follow-up of 125.1 days (P = 0.01). Anatomic success was achieved in 96.4% of eyes after a single surgery. CONCLUSION: Twenty-seven-gauge vitrectomy was safe and feasible in selected pediatric vitreoretinopathies. Further studies are warranted to examine indications and outcomes.

Authenticated Public Key Elliptic Curve Based on Deep Convolutional Neural Network for Cybersecurity Image Encryption Application.

The demand for cybersecurity is growing to safeguard information flow and enhance data privacy. This essay suggests a novel authenticated public key elliptic curve based on a deep convolutional neural network (APK-EC-DCNN) for cybersecurity image encryption application. The public key elliptic curve discrete logarithmic problem (EC-DLP) is used for elliptic curve Diffie-Hellman key exchange (EC-DHKE) in order to generate a shared session key, which is used as the chaotic system's beginning conditions and control parameters. In addition, the authenticity and confidentiality can be archived based on ECC to share the EC parameters between two parties by using the EC-DHKE algorithm. Moreover, the 3D Quantum Chaotic Logistic Map (3D QCLM) has an extremely chaotic behavior of the bifurcation diagram and high Lyapunov exponent, which can be used in high-level security. In addition, in order to achieve the authentication property, the secure hash function uses the output sequence of the DCNN and the output sequence of the 3D QCLM in the proposed authenticated expansion diffusion matrix (AEDM). Finally, partial frequency domain encryption (PFDE) technique is achieved by using the discrete wavelet transform in order to satisfy the robustness and fast encryption process. Simulation results and security analysis demonstrate that the proposed encryption algorithm achieved the performance of the state-of-the-art techniques in terms of quality, security, and robustness against noise- and signal-processing attacks.

Physical Layer Authenticated Image Encryption for IoT Network Based on Biometric Chaotic Signature for MPFrFT OFDM System.

In this paper, a new physical layer authenticated encryption (PLAE) scheme based on the multi-parameter fractional Fourier transform-Orthogonal frequency division multiplexing (MP-FrFT-OFDM) is suggested for secure image transmission over the IoT network. In addition, a new robust multi-cascaded chaotic modular fractional sine map (MCC-MF sine map) is designed and analyzed. Also, a new dynamic chaotic biometric signature (DCBS) generator based on combining the biometric signature and the proposed MCC-MF sine map random chaotic sequence output is also designed. The final output of the proposed DCBS generator is used as a dynamic secret key for the MPFrFT OFDM system in which the encryption process is applied in the frequency domain. The proposed DCBS secret key generator generates a very large key space of 22200. The proposed DCBS secret keys generator can achieve the confidentiality and authentication properties. Statistical analysis, differential analysis and a key sensitivity test are performed to estimate the security strengths of the proposed DCBS-MP-FrFT-OFDM cryptosystem over the IoT network. The experimental results show that the proposed DCBS-MP-FrFT-OFDM cryptosystem is robust against common signal processing attacks and provides a high security level for image encryption application.

Time Reduction for SLM OFDM PAPR Based on Adaptive Genetic Algorithm in 5G IoT Networks.

In this paper, a new peak average power and time reduction (PAPTR) based on the adaptive genetic algorithm (AGA) strategy is used in order to improve both the time reduction and PAPR value reduction for the SLM OFDM and the conventional genetic algorithm (GA) SLM-OFDM. The simulation results demonstrate that the recommended AGA technique reduces PAPR by about 3.87 dB in comparison to SLM-OFDM. Comparing the suggested AGA SLM-OFDM to the traditional GA SLM-OFDM using the same settings, a significant learning time reduction of roughly 95.56% is achieved. The PAPR of the proposed AGA SLM-OFDM is enhanced by around 3.87 dB in comparison to traditional OFDM. Also, the PAPR of the proposed AGA SLM-OFDM is roughly 0.12 dB worse than that of the conventional GA SLM-OFDM.

Bioequivalence Studies of Sildenafil Citrate Orodispersible Film Administered with and without Water vs ViagraⓇ Film-Coated Tablets in Healthy Male Volunteers.

Background: Orodispersible film (ODF) formulation offers ease of use, convenience of administration, and other advantages, especially for patients who have difficulty in swallowing or are on liquid restriction compared with conventional oral formulations for the treatment of erectile dysfunction. Objectives: These studies compared the bioequivalence of 50 mg sildenafil citrate ODF formulation (test drug) with the marketed 50 mg sildenafil citrate film-coated tablet (FCT) (ViagraⓇ; Pfizer, New York, NY) (reference drug), with and without water in 2 randomized cross-over studies. Methods: Two randomized cross-over studies were conducted. The first study explored the bioequivalence of test drug administered with and without water compared with the reference drug with water. The second study investigated the bioequivalence of test drug, without water, compared with the reference drug with water. Forty-two and 80 healthy male volunteers were recruited in the first and second study, respectively. All volunteers fasted for 10 hours pre-dose. A 1-day washout period between doses was observed. Blood samples were collected at both before (up to 120 minutes before dosing) and after dosing (at different intervals up to 14 hours) stages. Statistical analyses on pharmacokinetic parameters were performed. Safety and tolerability for both the formulations were evaluated. Results: In the first study, bioequivalence was demonstrated for sildenafil citrate ODF administered with water when compared with the ViagraⓇ FCT. The ratios of adjusted geometric means (90% confidence interval (CI)) were maximum plasma concentration: 1.02 (94.91-108.78) and area under the plasma concentration-time curve: 1.09 (104.49-113.21) for sildenafil citrate ODF administered with water vs ViagraⓇ FCT. These ratios were within the bioequivalence acceptance range of 80% to 125%, indicating that the bioequivalence criteria were met. The pharmacokinetic parameters for the second study also showed bioequivalence for sildenafil citrate ODF (without water) compared with ViagraⓇ FCT. The ratios of adjusted geometric means (90% CI) were maximum plasma concentration: 1.02 (95.47-109.36) and area under the plasma concentration-time curve: 1.06 (103.42-108.40) for sildenafil citrate ODF administered without water vs ViagraⓇ FCT. Adverse events in both the studies occurred at similar rates for the 2 formulations and were mild in intensity. Conclusions: These results suggest that the new ODF formulation can be used interchangeably with the marketed FCT formulation. Sildenafil citrate ODF administered with and without water met bioequivalence criteria compared with ViagraⓇ FCT administered with water under fasted conditions in healthy adult male volunteers. The new ODF formulation can be used as a suitable alternative to the conventional oral solid dosage form.

LONG-TERM VISUAL OUTCOMES AND THE TIMING OF SURGICAL REPAIR OF FOVEA-SPLITTING RHEGMATOGENOUS RETINAL DETACHMENTS.

PURPOSE: To evaluate the visual outcomes and the affect of timing of surgical repair of fovea-splitting rhegmatogenous retinal detachments. METHOD: A retrospective, consecutive cohort from multiple surgeons at a single center. Fovea status (fovea-on, fovea-splitting, or fovea-off) was classified by preoperative optical coherence tomography. The primary outcome measure was the visual acuity at the last follow-up that was further correlated with the timing of surgical repair. RESULTS: One hundred and ninety-five eyes were included with 62 fovea-on, 65 fovea-splitting, and 68 fovea-off detachments. The mean preoperative logarithm of the minimum angle of resolution visual acuity for fovea-on, fovea-splitting, and fovea-off groups was 0.16 ± 0.21, 0.70 ± 0.56, and 1.67 ± 0.87, respectively (P = <0.001). Mean postoperative logarithm of the minimum angle of resolution visual acuity for fovea-on, fovea-splitting, and fovea-off groups were 0.07 ± 0.13, 0.10 ± 0.15, and 0.20 ± 0.22, respectively (P = <0.001). A statistically significant difference in mean postoperative logMAR visual acuity was found between fovea-off and fovea-on groups (P = 0.003) and between fovea-off and fovea-splitting groups (P = 0.013), however not between fovea-on and fovea-splitting groups (P = 0.827). Visual acuity improved when repair was performed earlier after presentation for fovea-on (R = 0.378, P = 0.002) and fovea-off groups (R = 0.277, P = 0.022), but not for the fovea-splitting group (R = 0.089, P = 0.481). CONCLUSION: We described the favorable visual outcomes of surgery for fovea-splitting rhegmatogenous retinal detachment and correlated these with the timing of surgical repair, which may help guide the management of this urgent, vision-threatening condition.

Autologous Retinal Transplantation for Primary and Refractory Macular Holes and Macular Hole Retinal Detachments: The Global Consortium.

PURPOSE: To report the anatomic and functional outcomes of autologous retinal transplantation (ART). DESIGN: Multicenter, retrospective, interventional, consecutive case series. PARTICIPANTS: One hundred thirty eyes of 130 patients undergoing ART for the repair of primary and refractory macular holes (MHs), as well as combined MH-rhegmatogenous retinal detachment (MH-RRD), between January 2017 and December 2019. METHODS: All patients underwent pars plana vitrectomy and ART, with surgeon modification of intraoperative variables. A large array of preoperative, intraoperative, and postoperative data was collected. Two masked reviewers graded OCT images. Multivariate statistical analysis and subgroup analysis were performed. MAIN OUTCOME MEASURES: Macular hole closure rate, visual acuity (VA), external limiting membrane and ellipsoid zone (EZ) band integrity, and alignment of neurosensory layers (ANL) on OCT. RESULTS: One hundred thirty ART surgeries were performed by 33 vitreoretinal surgeons worldwide. Patient demographics were: mean age of 63 ± 6.3 years, 58% female, 41% White, 23% Black, 19% Asian, and 17% Latino. Preoperative VA was 1.37 ± 0.12 logarithm of the minimum angle of resolution (logMAR; Snellen equivalent, approximately 20/500), which improved significantly to 1.05 ± 0.09 logMAR (Snellen equivalent, approximately 20/225; P < 0.001) after surgery (mean follow-up, 8.6 ± 0.8 months). Autologous retinal transplantation was performed for primary MH repair in 27% of patients (n = 35), for refractory MH in 58% of patients (n = 76; mean number of previous surgeries, 1.6 ± 0.2), and for MH-RRD in 15% of patients (n = 19). Mean maximum MH diameter was 1470 ± 160 µm, mean minimum diameter was 840 ± 94 µm, and mean axial length was 24.6 ± 3.2 mm. Overall, 89% of MHs closed (78.5% complete; 10% small eccentric defect), with a 95% closure rate in MH-RRD (68.4% complete; 26.3% small eccentric defect). Visual acuity improved by at least 3 lines in 43% of eyes and by at least 5 lines in 29% of eyes. Reconstitution of the EZ (P = 0.02) and ANL (P = 0.01) on OCT were associated with better final VA. Five cases of ART graft dislocation (3.8%), 5 cases of postoperative retinal detachment (3.8%), and 1 case of endophthalmitis (0.77%) occurred. CONCLUSIONS: In this global experience, patients undergoing ART for large primary and refractory MHs and MH-RRDs achieved good anatomic and functional outcomes, with low complication rates despite complex surgical pathologic features.

FEATURES AND OUTCOMES OF EYES THAT UNDERWENT SURGICAL REPAIR OF RHEGMATOGENOUS RETINAL DETACHMENTS AFTER BEING TREATED FOR ACUTE ENDOPHTHALMITIS.

PURPOSE: To evaluate the etiology, clinical course, and outcomes of eyes that suffered postendophthalmitis rhegmatogenous retinal detachments. METHODS: A retrospective, consecutive case series was conducted of patients managed at Associated Retinal Consultants P.C. from January 2013 to December 2019. Patients were identified as having had endophthalmitis by ICD-9/10 codes. Those with endophthalmitis and/or rhegmatogenous retinal detachment not managed at Associated Retinal Consultants from January were excluded. RESULTS: Charts of 413 patients were reviewed and 19 met inclusion criteria. Incidence of rhegmatogenous retinal detachment following infectious endophthalmitis was 4.6%. The most common inciting events for endophthalmitis was intravitreal injection (9 of 19) and cataract surgery (7 of 19). Fifteen of 19 patients were treated with an injection of intravitreal antibiotics and 4 underwent immediate vitrectomy with antibiotic injection. Biopsy cultures were obtained in 18 of 19 patients and yielded positive growth in 12 (66.7%). Seventeen of the 19 eyes were operable. Final retinal reattachment rate was 88.2% (15 of 17). Mean final logMAR visual acuity was 1.58 (Snellen 20/765). Factors associated with worse final visual acuity after surgical repair included preceding intravitreal injection (P = 0.001), streptococcus species (P = 0.024), presence of proliferative vitreoretinopathy (P = 0.015), and use of silicone oil during primary rhegmatogenous retinal detachment repair (P = 0.010). CONCLUSION: Rhegmatogenous retinal detachments following endophthalmitis occur infrequently. Although most eyes can be repaired surgically, visual outcomes are often poor, particularly in eyes that were infected with streptococcal species and had associated proliferative vitreoretinopathy.

REFRACTIVE OUTCOMES AFTER SUTURELESS INTRASCLERAL FIXATION OF INTRAOCULAR LENS WITH PARS PLANA VITRECTOMY.

PURPOSE: To evaluate the refractive outcomes of sutureless intrascleral fixation of intraocular lens with pars plana vitrectomy. METHOD: A retrospective, consecutive cohort from multiple surgeons of a single center. Primary outcomes included spherical equivalent (SEQ) and change in SEQ (ΔSEQ) from preoperative intraocular lens power calculations. Secondary outcomes included refractive outcomes of fixation at 1.5 mm, 2 mm, and 2.5 mm posterior to the limbus. RESULTS: In total, 84 eyes of 80 patients were included. Preoperative logarithm of the minimum angle of resolution visual acuity was 1.21 ± 0.68 (20/320). The mean follow-up time was 2.33 ± 1.36 years. At 3 months, SEQ was -0.50 ± 1.59 D and ΔSEQ was 0.58 ± 1.49 D. At 1 year, SEQ was -0.55 ± 1.32 D and ΔSEQ was 0.39 ± 1.42 D. At the last follow-up, logarithm of the minimum angle of resolution visual acuity was 0.34 ± 0.34 (20/40), SEQ was -0.51 ± 1.44 D, and ΔSEQ was 0.57 ± 1.27 D. There was no difference between SEQ or ΔSEQ throughout follow-up (P = 0.97 and P = 0.96, respectively). At fixation distances more posterior to the limbus, mean ΔSEQ was more hyperopic at 3 months, 1-year, and the last follow-up (P = 0.02, P = 0.01, and P = 0.006, respectively). CONCLUSION: Refractive outcomes for sutureless intrascleral fixation of intraocular lens with pars plana vitrectomy were favorable and showed stability postoperatively. These results may aid surgeons achieve better desired refractive outcomes for this technique.

PERIPHERAL RETINAL ANGIOGRAPHIC FINDINGS IN MACULAR TELANGIECTASIS TYPE 2.

PURPOSE: To evaluate the retinal periphery in patients with idiopathic juxtafoveal telangiectasis or macular telangiectasis Type 2 (MacTel2), using widefield fluorescein angiography. METHODS: Single-center, retrospective, observational case series of 50 eyes of 50 patients with MacTel2 and 50 eyes of 50 age-matched controls. RESULTS: Thirty-seven eyes in the MacTel2 group (74%) showed peripheral capillary nonperfusion or dropout, compared with 37 eyes in the control group (74%, P = 1.0). Morphologically, the MacTel2 group trended toward having a higher proportion of pruning-type capillary dropout (44%) compared with controls (28%), but this was not statistically significant (P = 0.12). Patients with MacTel2 had a higher incidence of microaneurysms compared with controls (MacTel2 56%; controls 42%; P = 0.048), independent of age or systemic risk factors. There was no difference in the incidence of venous-venous shunts (MacTel2 10%; controls 10%; P = 1.0), arteriovenous shunts (MacTel2 14%; controls 18%; P = 0.60), venous tortuosity (MacTel2 60%; controls 66%; P = 0.58), or arterial tortuosity (MacTel2 54%; controls 68%; P = 0.20), which was mild in most cases. CONCLUSION: We note a high incidence of peripheral vascular and retinal findings in both patients with MacTel2 and age-matched controls, using widefield fluorescein angiography. Patients with MacTel2 had significantly more microaneurysms, independent of age or other systemic risk factors.

CLINICAL OUTCOMES AND TREATMENT COURSE OF EYES WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION FOLLOWING THE DEVELOPMENT OF ENDOPHTHALMITIS.

PURPOSE: To evaluate the clinical course of patients with neovascular age-related macular degeneration (nAMD) after developing endophthalmitis during their treatment with intravitreal injections. METHODS: Multicenter, retrospective series. RESULTS: From April 2013 to October 2018, 196,598 intravitreal anti-vascular endothelial growth factor (VEGF) injections were performed, with 75 cases of endophthalmitis (incidence 0.0381%). There was no association between intravitreal anti-VEGF drug (P = 0.29), anesthetic method (P = 0.26), povidone concentration (P = 0.22), or any intraprocedure variable and endophthalmitis incidence. Seventy-two patients (96%) were treated with intravitreal tap and inject , while 3 underwent immediate pars plana vitrectomy. After endophthalmitis resolution, 17 patients (22.7%) were not re-treated for nAMD (in 10 cases due to inactive disease; follow-up, 115 ± 8.4 weeks). Patients required less frequent anti-VEGF injections after infection (7.4 ± 0.61 weeks vs. 11.5 ± 1.8 weeks; P = 0.004). Preinfection logarithm of the minimum angle of resolution visual acuity was 0.585 ± 0.053 (∼20/77). It worsened with endophthalmitis (1.67 ± 0.08, ∼20/935; P < 0.001) and again on postendophthalmitis treatment day 1 (1.94 ± 0.064; count fingers; P < 0.001), but improved after reinitiating nAMD therapy (1.02 ± 0.11; ∼20/209; P < 0.001). Better visual acuity on postendophthalmitis week 1 (P = 0.002) and reinitiation of nAMD treatment (P = 0.008) were associated with better final visual acuity, and streptococcal culture with worse visual acuity (P = 0.028). The postendophthalmitis treatment interval was associated with the anti-VEGF drug used (aflibercept = ranibizumab > bevacizumab; P < 0.001). CONCLUSION: Patients with nAMD required fewer injections after endophthalmitis, suggesting a biological change in disease activity. Neovascular age-related macular degeneration became quiescent in 13.3% of eyes. Most achieved better outcomes with anti-VEGF reinitiation.

Phosphodiesterase Type-5 Inhibitor Prescription Patterns in the United States Among Men With Erectile Dysfunction: An Update.

BACKGROUND: While phosphodiesterase type-5 inhibitors (PDE5Is) are highly effective for the treatment of erectile dysfunction (ED) and well tolerated, updated data on prescription patterns have been limited in real-world settings. AIM: To describe men in the United States who are prescribed PDE5Is for ED treatment and to evaluate patterns of initiation, switching, and treatment overlap. METHODS: This retrospective claims study used MarketScan Commercial and Medicare Supplement Databases from January 1, 2010, to December 31, 2015, to identify initial PDE5I claims (index date) for sildenafil, tadalafil, and/or vardenafil. Adults aged ≥18 years with ED were identified between July 1, 2010, and December 31, 2014, allowing for a 6-month preindex and 12-month follow-up period from the index date. OUTCOMES: Outcomes included patient demographics and treatment-related patterns after treatment initiation. RESULTS: A total of 106,206 identified patients met all inclusion criteria. Of these, 51,694, 40,193, and 14,319 had initial claims for sildenafil, tadalafil, and vardenafil, respectively. Mean age was 50.35 years, and comorbidities included dyslipidemia (44.17%), hypertension (43.09%), diabetes (15.32%), and depression (10.61%). More patients (48.67%) initiated on sildenafil than tadalafil (37.85%) or vardenafil (13.48%). Rate of switching was lower in the 60 days after the end of day supply of the initial prescription in the sildenafil cohort (2.71%) compared with the tadalafil (2.81%) and vardenafil (3.88%) cohorts (P < .001 for sildenafil vs tadalafil or vardenafil). Treatment overlap was lower in the sildenafil cohort (0.35%) than in the tadalafil (0.75%) and vardenafil (0.62%) groups (P < .001 for sildenafil vs tadalafil or vardenafil). CLINICAL IMPLICATIONS: These findings provide insight into updated patterns of PDE5I prescriptions in the United States and may aid in clinical decision-making. STRENGTHS & LIMITATIONS: Strengths include the large sample size, long data coverage period, and the real-world nature of the study. Limitations include the retrospective study design, use of data collected with a primary focus of claims, and lack of further details regarding reasons that drive switching. Actual rates of ED and impact on prescription patterns may be underestimated because the claims database only captured patients electing to visit a health-care provider. CONCLUSION: Among men with ED in the United States, rates of switching and treatment overlap were low for all PDE5Is but were found to be the lowest for sildenafil compared with tadalafil and vardenafil. Mulhall JP, Chopra I, Patel D, et al. Phosphodiesterase Type-5 Inhibitor Prescription Patterns in the United States Among Men With Erectile Dysfunction: An Update. J Sex Med 2020;17:941-948.

Integrated care for the management of ageing-related non-communicable diseases: current gaps and future directions.

Due to the increase in the older population in Europe and associated rise in the absolute number of persons with Non-Communicable Diseases (NCDs), it is becoming increasingly important to find ways to promote healthy ageing, which is defined as the process of developing and maintaining the functional ability that enables well-being in older age. Older persons with NCDs can have complex care needs due to the increased risk of frailty, multimorbidity, and polypharmacy. However, current health systems in Europe often provide fragmented care for older people with NCDs; many receive disjointed care from numerous specialists or via different levels of care. In the current article, we discuss barriers and challenges in implementing integrated care models in European settings for older NCD patients. Specifically, we discuss the need for greater use of case managers in the care and treatment persons with complex care needs as well as the lack of training and education in healthcare professionals on topics related to multimorbidity, frailty, and polypharmacy. We discuss the limitations that arise from the current focus on disease-specific guidelines and care models that do not take comorbid conditions into account, and the lack of good quality evidence that evaluates the effectiveness of integrated care interventions, especially in European health settings. We highlight the importance of evaluating and monitoring mental health in conjunction with somatic symptoms in NCD patients and discuss the integral role of information and communication technology in healthcare to streamline integrated care processes and help to achieve better outcomes for patients.

Prevalence and impact of lower urinary tract symptoms: Results of the epic survey in Egypt.

AIMS: To estimate the prevalence of lower urinary tract symptoms (LUTS), including overactive bladder (OAB), and urinary incontinence (UI), in Egypt and the impact on patients' quality of life. METHODS: A population-based, cross-sectional survey (EPIC) was conducted with a random sample of adults aged ≥18 years. Prevalence estimates were based on 2002 International Continence Society definitions. RESULTS: A total of 3600 adult men and women participated in the survey; 86% of them experienced ≥1 LUTS: storage symptoms were more frequently reported (75%) than voiding (52%) or postmicturition (42%) symptoms. The most prevalent storage symptom was nocturia (defined as ≥1 time per night) in 70% of the population. UI was reported by 21% (mixed UI [MUI]: 9%; stress UI [SUI]: 4%; urgency UI [UUI]: 5%; other UI: 3%), and 30% met criteria for OAB. Despite the high prevalence of LUTS, few individuals with UUI, MUI, SUI, or OAB took prescription medicine (12%) or consulted a healthcare professional about their symptoms (23%). CONCLUSION: High prevalence rates of LUTS and OAB were found in adult men and women in Egypt, although low healthcare utilization and low prescription medication use for symptoms were observed.