Prospective Randomized Clinical Trial Research Articles

Arthroscopic and open reconstruction of the posterolateral corner of the knee have equally good clinical results: first results of a prospective 12-month follow-up study.

Arthroscopic reconstruction techniques for higher-grade posterolateral corner (PLC) injuries (Fanelli Type B, PoLIS LI-B) have not yet been validated in clinical studies. The open reconstruction technique described by Arciero is well-established and showed good restoration of joint stability in previous studies. This study aimed to compare clinical outcomes of this established open surgery technique to a newly developed arthroscopic technique in a prospective randomized clinical trial. Between 2019 and 2021, this study focused on chronic high-grade PLC injuries (Fanelli Type B, PoLIS LI-B). Group A consisted of patients treated with conventional open surgery following Arciero's technique, while Group B included patients treated with Arciero's arthroscopic technique. All cases underwent additional PCL reconstruction. After a minimum 12-month follow-up, clinical scores and objective stability assessments were compared between the groups. In total, 26 (group A 12, group B 14) eligible patients with a mean follow-up of 14.9 ± 7.2 months were evaluated in the present study. Knee stability and patient-reported outcome scores (PROMS) were significantly improved when comparing pre- and post-operative values (p < 0.0001). No clinically relevant differences in PROMS (Lysholm: A 83.9 ± 11.4 vs. B 85.3 ± 13.8; IKDC: A 76.91 ± 12.6 vs. B 76.8 ± 15.7) were shown in both groups. Additionally, no statistically significant differences were detected between groups with respect to external rotation, range of motion and instrumental stability testing. Arthroscopic reconstruction showed significantly shorter operation time (p = 0.0109). There were no clinical failures or neurovascular complications of the surgical procedures. Both surgical techniques for isolated chronic PLC Fanelli Type B injuries significantly improved the knee stability, were equivalent with respect to PROMs and led to good clinical results. However, arthroscopic PLC reconstruction was associated with a shorter surgery time compared to open PLC reconstruction. Therefore, arthroscopic PLC reconstruction may be a viable option in the hands of an experienced surgeon. Prospective cohort study, II.

Mediating effect of gestational weight gain on the preventive effect of exercise during pregnancy on macrosomia: a randomized clinical trial.

We sought to investigate the impact of individualized exercise guidance during pregnancy on the incidence of macrosomia and the mediating effect of gestational weight gain (GWG). A prospective randomized clinical trial. A Hospital in Xingtai District, Hebei Province. Older than 20years of age, mid-pregnancy, and singleton pregnant women without contraindications to exercise during pregnancy. A randomized clinical trial was conducted from December 2021 to September 2022 to compare the effects of standard prenatal care with individualized exercise guidance on the incidence of macrosomia. Incidence of macrosomia. In all, 312 singleton women were randomized into an intervention group (N = 162) or a control group (N = 150). Participants who received individualized exercise guidance had a significantly lower incidence of macrosomia (3.73% vs. 13.61%, P = 0.002) and infants large for gestational age (9.94% vs. 19.73%, P = 0.015). However, no differences were observed in the rate of preterm birth (1.86% vs. 3.40%, P = 0.397) or the average gestational age at birth (39.14 ± 1.51 vs. 38.69 ± 1.85, P = 0.258). Mediation analysis revealed that GWG mediated the effect of exercise on reducing the incidence of macrosomia. Individualized exercise guidance may be a preventive tool for macrosomia, and GWG mediates the effect of exercise on reducing the incidence of macrosomia. However, evidence does not show that exercise increases the rate of preterm birth or affects the average gestational age at birth. The trial is registered at www.clinicaltrails.gov [registration number: NCT05760768; registration date: 08/03/2023 (retrospectively registered)].

Clinical outcomes of a modified ophthalmic viscosurgical device-free implantable collamer lens implantation.

To investigate the efficacy and safety of a modified dual-incision ophthalmic viscosurgical device-free (OVD-free) method for implantable collamer lens (ICL) implantation in high myopic eyes. A total of 68 participants were enrolled in this prospective randomized clinical trial, including 33 in the OVD-free group and 35 in the standard group. Operation time and intraocular pressure (IOP) at 2 hours postoperatively were recorded. Visual acuity, refractive power, IOP, corneal endothelium parameters, and anterior segment parameters were assessed at 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively. Postoperative subjective visual quality at 3 months was recorded through a Quality of Vision (QoV) questionnaire. No significant differences in visual acuity, refractive outcomes, and corneal endothelial parameters were found, while the operation time was significantly shorter in the OVD-free group. Both groups showed a significant increase in IOP at 2 hours after surgery, but the increase in the OVD-free group was significantly smaller than that in the standard group. In addition, the frequency of ring-shaped dysphotopsia in the OVD-free group (15.15%) was significantly lower than that in the standard group (40%), and the severity and annoyance of this symptom were also significantly lower in the OVD-free group. The modified OVD-free ICL implantation is a safe, effective, and predictable method for myopia correction, which could be a better choice for short surgery time, better subjective visual perception, and low occurrence of IOP elevation.

Histologically Overt Stromal Response and the Risk of Progression after Radical Prostatectomy for Prostate Cancer.

Given the variable clinical course of prostate cancer and the limitations of current prognostic factors, this study was conducted to investigate the impact of a histologically overt stromal response (HOST-response) to prostate cancer on clinical outcomes after radical prostatectomy. This retrospective analysis utilized The Cancer Genome Atlas (TCGA) to evaluate data from individuals with a confirmed diagnosis of prostate cancer who underwent radical prostatectomy and had available pathology slides. These slides were assessed for the presence of a HOST-response, similar to desmoplasia. The primary endpoint was progression-free survival (PFS). A multivariable competing risk regression analysis was used to assess whether a significant association existed between HOST-response and PFS, adjusting for known prostate cancer prognostic factors. Among the 348 patients analyzed, 166 (47.70%) demonstrated a HOST-response. After a median follow-up of 37.87 months (IQR: 21.20, 65.50), the presence of a HOST-response was significantly associated with a shorter PFS (SDHR, 2.10; 95% CI, 1.26 to 3.50; p = 0.004), after adjusting for covariates. HOST-response in prostate cancer patients treated with radical prostatectomy is significantly associated with reduced PFS, suggesting a potential benefit from adjuvant therapy and highlighting the need for further investigation in a prospective randomized clinical trial.

Prospective Randomized Clinical Trial Evaluating Efficacy and Safety of A New Ophthalmic Viscosurgical Device In Patients Undergoing Cataract Surgery.

To evaluate the efficacy and safety of Bio-Hyalur LVD compared to Viscoat® ophthalmic viscosurgical device (OVD) in patients undergoing routine cataract surgery. Two tertiary eye care hospitals in Italy. Prospective randomized clinical trial. This study compared the outcomes of Bio-Hyalur LVD versus Viscoat® ophthalmic viscosurgical device in patients undergoing standard cataract surgery with phacoemulsification and intraocular lens implantation from January 2021 to April 2022. The primary outcome was mean change in IOP at 6 hours. Secondary outcomes included 1-, 7-, 30- and 90-day mean intraocular pressure (IOP), 7-, 30- and 90-day best corrected visual acuity, endothelial cell density (ECD), change in central corneal thickness (CCT) and complications including intraocular inflammation. A total of 84 eyes of 84 patients (n = 41 in the Bio-Hyalur LVD group and n = 43 in the Viscoat group) were screened, enrolled, randomized, and included in the analysis. Mean change in IOP was significantly higher in the Viscoat group than in the Bio-Hyalur LVD group 6 hours (p = 0.034), 7 days (p < 0.001), 30 days (p < 0.001) and 90 days (p = 0.003) postoperatively. Mean change in UDVA and CDVA was significantly higher in the Bio-Hyalur LVD group 30 and 90 after surgery. No significant differences in ECD, CCT and complication rates were observed between groups at any time point. Bio-Hyalur LVD OVD is safe and effective for use in patients undergoing routine cataract surgery. Bio-Hyalur LVD OVD did not confer a higher risk of postoperative increase in IOP.

Effects of antioxidant supplementation for polycystic ovary syndrome

Introduction and purpose: Polycystic ovary syndrome is the most common endocrinopathy in women, with a prevalence ranging from 10% to 13%. Oxidative stress and decreased antioxidant levels contribute to the development of various diseases, and one of them is polycystic ovary syndrome. The aim of this review is to provide an overview of the current knowledge about the effects of antioxidant administration in PCOS treatment. A brief description of the state of knowledge: Oxidative stress is an imbalance between increased levels of reactive oxygen species and a decreased efficiency of antioxidant mechanisms, which can potentially cause damage. The harmful effects of free radicals might be neutralized by antioxidants obtained from the diet, such as polyphenols, vitamins C, and E. These compounds improve several aspects of the PCOS pathomechanism, including hormonal imbalance, glucose metabolism, lipid profile, and ovarian functionality. Conclusions: The outcomes of all the reviewed studies in this paper indicate that antioxidants such as resveratrol, curcumin, vitamin C and E, N-acetylcysteine, and melatonin have therapeutic potential in the management of PCOS. However, currently antioxidant therapies cannot be recommended in PCOS therapy since there is a need for more prospective randomized clinical trials on a larger sample to establish a long-term effects of antioxidants supplementation in PCOS, the optimal dosage, and finally to assess which antioxidant is the most efficient in PCOS treatment.

Effects of antioxidant supplementation for polycystic ovary syndrome

Introduction and purpose: Polycystic ovary syndrome is the most common endocrinopathy in women, with a prevalence ranging from 10% to 13%. Oxidative stress and decreased antioxidant levels contribute to the development of various diseases, and one of them is polycystic ovary syndrome. The aim of this review is to provide an overview of the current knowledge about the effects of antioxidant administration in PCOS treatment. A brief description of the state of knowledge: Oxidative stress is an imbalance between increased levels of reactive oxygen species and a decreased efficiency of antioxidant mechanisms, which can potentially cause damage. The harmful effects of free radicals might be neutralized by antioxidants obtained from the diet, such as polyphenols, vitamins C, and E. These compounds improve several aspects of the PCOS pathomechanism, including hormonal imbalance, glucose metabolism, lipid profile, and ovarian functionality. Conclusions: The outcomes of all the reviewed studies in this paper indicate that antioxidants such as resveratrol, curcumin, vitamin C and E, N-acetylcysteine, and melatonin have therapeutic potential in the management of PCOS. However, currently antioxidant therapies cannot be recommended in PCOS therapy since there is a need for more prospective randomized clinical trials on a larger sample to establish a long-term effects of antioxidants supplementation in PCOS, the optimal dosage, and finally to assess which antioxidant is the most efficient in PCOS treatment.

Abstract PO4-13-04: Added Value from Patient Advocates in a Translational Working Group: the COMET Study

Abstract Introduction: A phase III multicenter prospective randomized clinical trial called “Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET)” (NCT02926911) assesses the risks/benefits of active monitoring (AM) versus surgery for women with low-risk ductal carcinoma in situ (DCIS). It is funded by the Patient-Centered Outcomes Research Institute and enrolled 997 women between 06/30/17 and 01/13/23. Research Patient Advocates (PAs) have been embedded from the study design stage and continue to provide guidance as part of the COMET leadership team. The COMET biobank is funded by independent foundations and is managed through monthly Translational Working Group (TWG) meetings. The TWG includes PAs, clinicians, pathologists, radiologists, and researchers from multiple institutions who discuss topics like categorization of biospecimens into discovery/validation sets; development of a pathology workflow/sample tracking process; use of small samples; and potential areas of future research/technologies that may improve DCIS diagnostics, prognostics, and care management. Methods: The TWG leveraged the existing Alliance Foundation Trials, LLC biobank infrastructure and facilitates the collection, submission, storage and analysis/use of blood, tissue, and breast images collected at specified timepoints and stored in central tissue/image repositories. PAs are active and integral in the TWG, assisting with logistical issues (contracts, transfer agreements, resource requests); communicating with sites; identifying study topics and biomarkers relevant to diverse patients; providing guidance on commercial predictive/prognostic tests; promoting effective stewardship of samples; ensuring overall focus remains on advancing clinical utility; and reporting translational study results to trial participants who agreed to donate samples/images. Results: Over 90% of requested samples/images have been submitted by ˃85 sites. Each patient’s biospecimens and pathology images are linked and de-identified for research. Use of artificial intelligence (AI) is being considered to assist in sample review. TWG members have complementary areas of expertise/experience and promote active stewardship for effective management of these scarce resources. PAs have played key roles concerning equitable data-sharing and acceleration of data and material transfer agreements. They have also been active in development of standards for discovery/training sets, validation test sets; communication procedures for patient cases that progress to future breast events; ways to catalog technologies (e.g., multi-omics, AI); and in research proposal review. Consensus has been achieved regarding major issues such as authorship, biospecimen custodianship, intellectual property, and criteria relevant to patient needs. Logistical barriers, including data sharing and technicalities of biospecimen release, have been resolved. The TWG also played an integral role in resolving recruitment challenges to COMET by creating standard pathology eligibility criteria, resulting in evidence-based protocol amendments that increased accrual. A retrospective review of biospecimens has been performed to determine adequacy for ensuing correlative molecular and spatial profiling studies. Conclusion: PAs help the COMET TWG set policy, and oversee biospecimen/image collection, and biobank use and sharing. PA input also facilitates equitable, transparent research studies and technology development that can improve personalized decisions for surgery versus AM in women with low-risk DCIS. PAs in the TWG aim to integrate the diagnostic and prognostic tools developed as part of the COMET study into future patient care. Citation Format: Deborah Collyar, Desiree Basila, Thomas Lynch, Stuart Schnitt, Jeffrey Marks, Siri Strand, Terry Hyslop, Sunil Badve, Mark Watson, H. T. Carisa Le-Petross, Lars Grimm, Robert West, Anna Weiss, Anna Rapperport, Lorraine King, Rachel Factor, Marc Ryser, Ann Partridge, E Shelley Hwang, Alastair Thompson. Added Value from Patient Advocates in a Translational Working Group: the COMET Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-13-04.

Using Administrative Data to Better Treat Chronic Limb Threatening Ischemia

Chronic limb threatening ischemia (CLTI) is the most severe manifestation of peripheral arterial disease represents a particularly high-risk subgroup of patients. As such, efforts to better understand this complex patient population through well-designed clinical research studies are critical to improving CLTI care. Prospective randomized clinical trials (RCTs) remain the gold standard in clinical research, but these trials are resource-intensive and have highly selective patient populations, which limit their feasibility and generalizability. Alternatively, retrospective studies are less expensive than RCTs, have a larger sample size, and are more generalizable owing to a broader patient population. Health care administrative data provide rich sources of information that may be used for research purposes and are increasingly being used for the study of vascular surgery conditions, including CLTI. Although administrative data are collected for billing purposes, they may be leveraged to study a broad range of topics in vascular surgery including those related to health care delivery, epidemiology, health disparities, and outcomes. This review provides an overview of administrative data available for CLTI research, the strengths and limitations of these data sources, current areas of investigation, and future opportunities for further study with the goal of improving outcomes in this high-risk population.

Efficacy of clear aligner therapy over conventional fixed appliances in controlling orthodontic movement: A systematic review.

The purpose of the current systematic review was to answer the clinical research question "Is Clear Aligner Therapy (CAT) effective in controlling the orthodontic movement?" by bringing together the most up-to-date information about the available evidence for CAT. On January 1, 2023, a search was conducted in PubMed, ERIC, Embase, and CINHAL for any research papers published in the previous 10 years that provided an overview of the PICO questions. Both the titles and abstracts of the selected studies were evaluated independently by two different authors, and if there was any disagreement between the two review authors, a third reviewer was brought in to settle it. Among included studies, three were retrospective non-randomized and two studies were prospective randomized clinical trials. Various authors reported better outcome for fixed orthodontic appliances than for clear aligner treatment (CAT) in relation to mandibular incisor proclination. The mean objective grading system score was better for braces (17) than for CAT (12) with no clinically significant difference, while staging had a significant impact on treatment efficacy. The results of this study suggest that clear aligners may be an effective alternative to traditional braces, but more research is needed to confirm these findings and determine the optimal size of future prospective studies evaluating this treatment.

TaKeTiNa Music Therapy for Outpatient Treatment of Depression: Study Protocol for a Randomized Clinical Trial.

Depression is a prevalent and debilitating illness that significantly affects psychological and physical well-being. Apart from conventional therapies such as psychotherapy and medication, individuals with depression often lack opportunities for activities that are generally perceived as enjoyable, such as music, meditation, and arts, which have demonstrated therapeutic effectiveness. TaKeTiNa music therapy has been employed as a therapeutic intervention for more than two decades. However, there is a notable absence of well-designed clinical trials investigating its antidepressant effects, a gap we aim to address in our current study. Furthermore, shifts in the progression of depression may manifest both psychologically, by influencing emotional states, and physiologically, by leading to alterations in lipid and sphingolipid metabolism, cortisol levels, and immune system function. Our study seeks to analyze the impact of TaKeTiNa music therapy on both levels. This is a prospective monocentric randomized waitlist-controlled clinical trial. It investigates the influence of TaKeTiNa music therapy on patients with major depression in an outpatient setting. Therefore, interested persons are randomly assigned to two groups, an intervention group or a control group, after completing a screening procedure. The intervention group starts with an eight-week TaKeTiNa music therapy intervention. The waiting group receives the same therapy program after completing the follow-up period. Blood and saliva sampling as well as responses to questionnaires are obtained at specific time points. Our study investigates the effects of TaKeTiNa music therapy, a non-pharmacological antidepressant treatment option, on depressive symptoms. We also address functional and causal immunological changes; hormonal changes, such as changes in cortisol levels; and metabolic changes, such as changes in serum lipids and sphingolipids, during the course of depression. We expect that this study will provide evidence to expand the range of treatment options available for depression.

Comparison of the dural puncture epidural and the standard epidural techniques in patients having labor analgesia maintained using programmed epidural boluses: a prospective double-blinded randomized clinical trial

BackgroundThe dural puncture epidural technique has been shown in some studies to improve the onset and quality of the initiation of labor analgesia compared with the standard epidural technique. However,...

The clinical value of mNGS of bronchoalveolar lavage fluid versus traditional microbiological tests for pathogen identification and prognosis of severe pneumonia (NT-BALF):study protocol for a prospective multi-center randomized clinical trial.

Early, rapid, and accurate pathogen diagnosis can help clinicians select targeted treatment options, thus improving prognosis and reducing mortality rates of severe pneumonia. Metagenomic next-generation sequencing (mNGS) has a higher sensitivity and broader pathogen spectrum than traditional microbiological tests. However, the effects of mNGS-based antimicrobial treatment procedures on clinical outcomes and cost-effectiveness in patients with severe pneumonia have not been evaluated. This is a regional, multi-center, open, prospective, randomized controlled trial to evaluate that whether the combination of mNGS and traditional testing methods could decrease 28-day call-cause mortality with moderate cost-effectiveness. A total of 192 patients with severe pneumonia will be recruited from four large tertiary hospitals in China. Bronchoalveolar lavage fluid will be obtained in all patients and randomly assigned to the study group (mNGS combined with traditional microbiological tests) or the control group (traditional microbiological tests only) in a 1:1 ratio. Individualized antimicrobial treatment and strategy will be selected according to the analysis results. The primary outcome is 28-day all-cause mortality. The secondary outcomes are ICU and hospital length of stay (LOS), ventilator-free days and ICU-free days, consistency between mNGS and traditional microbiological tests, detective rate of mNGS and traditional microbiological tests, turn-out time, time from group allocation to start of treatment, duration of vasopressor support, types and duration of anti-infective regimens, source of drug-resistant bacteria or fungi, and ICU cost. The clinical benefits of mNGS are potentially significant, but its limitations should also be considered. ChineseClinicalTrialRegistry.org, ChiCTR2300076853. Registered on 22 October 2023.

Effect of pelvic floor fascial mobilization on pelvic floor dysfunction in multiparous pregnant women - A randomized pilot study

BackgroundPelvic floor fascial mobilization (PFFM) is an innovative intravaginal and/or intrarectal manual therapy technique developed to treat pelvic distress by improving fascial gliding and muscle function. AimThe effect of PFFM on pelvic floor distress during pregnancy was compared to conventional pelvic floor muscle training. MethodsA pilot prospective randomized clinical trial. The primary outcome was the strength and function of the pelvic floor muscles measured via the Oxford grading scale, perineometry, and hip range of motion. Each subject was treated twice, one week apart. ResultsForty multiparous pregnant women at 24–30 weeks gestation, with pelvic distress, were allocated to PFFM (study group (n = 20)) vs. pelvic floor muscle training (control group (n = 20)). There was no difference in the severity of pelvic distress between the study and control groups before the interventions (PFDI-20: 27.1 ± 12.2 vs. 26.0 ± 13.5, respectively, p = 0.7). Twenty-six subjects completed the study protocol. PFDI-20 showed significant improvement: 42% improvement in the study group vs. 12% improvement in the controls (p = 0.001 for both groups). Group-by-time interaction (Cohen's d) was significant after the first treatment session for Oxford score, right hip internal rotation range of motion, and cervical length in the PFFM group and for perineometry and right hip internal rotation at the end of the study. ConclusionsBased on this pilot randomized trial, PFFM may potentially and partially 1. Alleviate symptoms, 2. Improve pelvic floor function and strength, and 3. Elongate the cervix after one or two treatment sessions. Further, a more extensive study is needed to confirm these results.

Re: Gyawali, Sushil; Luitel, Bhoj Raj; Bhattarai, Amit Sharma; Sharma, Uttam Kumar. Comparison of efficacy of intercostal nerve block versus peritract infiltration with 0.25% bupivacaine in percutaneous nephrolithotomy: A prospective randomized clinical trial. Indian Journal of Urology 40(1):p 37-43, Jan-Mar 2024.

Re: Gyawali, Sushil; Luitel, Bhoj Raj; Bhattarai, Amit Sharma; Sharma, Uttam Kumar. Comparison of efficacy of intercostal nerve block versus peritract infiltration with 0.25% bupivacaine in percutaneous nephrolithotomy: A prospective randomized clinical trial. Indian Journal of Urology 40(1):p 37-43, Jan-Mar 2024.

Visual Field Outcomes in the Primary Tube Versus Trabeculectomy Study

PurposeTo describe visual field outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. DesignCohort analysis of a prospective multicenter randomized clinical trial. SubjectsA total of 155 eyes from 155 subjects randomly assigned to treatment with tube shunt surgery (n=84) or trabeculectomy with mitomycin C (n=71). MethodsThe PTVT Study was a multicenter randomized clinical trial comparing the safety and efficacy of trabeculectomy and tube shunt surgery in eyes without prior intraocular surgery. Subjects underwent standard automated perimetry (SAP) at baseline and annually for five years. SAP tests were deemed reliable if the false positive rate was ≤15%. Tests were excluded if visual acuity was ≤20/400 or loss of ≥2 Snellen lines from baseline were attributed to a non-glaucomatous etiology. Linear mixed-effects models were used to compare rates of change in SAP mean deviation (MD) between the two treatment groups. Intraocular pressure (IOP) control was assessed by percentage of visits with IOP <18 mmHg and mean IOP. Outcome MeasuresRate of change in SAP MD during follow-up. ResultsA total of 730 SAP tests were evaluated, with an average of 4.7 tests per eye. The average SAP MD at baseline was -12.8±8.3 dB in the tube group and -12.0±8.4 dB in the trabeculectomy group (p=0.57). The mean rate of change in SAP MD was -0.32±0.39 dB/year in the trabeculectomy group and -0.47±0.43 dB/year in the tube group (p=0.23). Eyes with mean IOP 14-17.5 mmHg had significantly faster rates of SAP MD loss compared to eyes with mean IOP <14 mmHg (-0.59±0.13 vs. -0.27±0.08 dB/year, p=0.012) and eyes with only 50-75% of visits with IOP <18 mmHg had faster rates than those with 100% of visits with IOP <18 mmHg (-0.90±0.16 vs. -0.29±0.08 dB/year, p<0.001). Multivariable analysis identified older age and worse IOP control as risk factors for faster progression in both treatment groups. ConclusionsNo statistically significant difference in mean rates of visual field change was observed between trabeculectomy and tube shunt surgery in the PTVT Study. Worse IOP control was significantly associated with faster rates of SAP MD loss during follow-up. Older patients were also at risk for faster progression.

Effects of intracameral dexamethasone injection versus topical steroids post phacoemulsification operation

Introduction Cataract surgery is one of the most commonly performed surgeries worldwide, with nearly 20 million cases annually. Ophthalmologists usually use a prophylactic perioperative regimen consisting of topical corticosteroids and nonsteroidal anti-inflammatory drugs to reduce the risk of inflammation. However, patient compliance and other problems concerning administration with elderly patients self-administering medication drops can vary widely and a wide proportion of them fail to comply with a long-term regimen. Aim Evaluation of intracameral dexamethasone injection efficacy and safety versus topical anti-inflammatory eyedrop regimens for postphacoemulsification inflammation for better postoperative management of cataract patients. Methodology A prospective randomized clinical trial. Participants were divided into two groups in group A, dexamethasone sodium-phosphate (0.4 mg/0.1 mL) was injected intracamerally at the end of phacoemulsification surgeries without topical steroids postoperatively. Group B: took the routine postoperative anti-inflammatory steroidal and nonsteroidal eye drop regimen. Results Included the corneal thickness that showed no discernible change between postoperative numbers in both groups. Nevertheless, there was a statistically significant increase in CCT postoperatively in both groups. The intraocular pressure decreased significantly after 1 month of phacoemulsification operation in both groups simultaneously. Postoperative cell density and hexagonality were significantly lower in both groups compared with preoperative values. There was also no significant difference between both groups regarding the anterior chamber cells’ index. Moreover, the Dexamethasone-injected group showed better compliance on the postoperative visits regarding their prescriptions taken after the operation compared with the Prednisone acetate eye drops group. Conclusions Better results regarding the severity of the endothelial damage with the use of a single intraoperative injection post phacoemulsification compared with the group who did not get injected but took postoperative prednisone acetate eye drops. The obligatory single intraoperative injection of dexamethasone has handled the poor compliance of some patients’ post phacoemulsification.

Ocular Effects of Prenatal Carotenoid Supplementation in the Mother and Her Child: The Lutein and Zeaxanthin in Pregnancy (L-ZIP) Randomized Trial - Report Number 2

PurposeLutein and zeaxanthin are xanthophyll carotenoids that have been promoted to enhance maternal health and infant visual and neurodevelopment. In this study, we determined the effects of prenatal lutein and zeaxanthin supplementation on systemic and ocular carotenoid status in the mother and her newborn infant (NCT03750968). This report focuses on the ocular effects of prenatal carotenoid supplementation. DesignA prospective randomized clinical trial with 47 subjects randomly assigned by 1:1 allocation to receive standard-of-care prenatal vitamins along with 10 mg lutein and 2 mg zeaxanthin softgel (Carotenoid Group) or standard-of-care prenatal vitamins with a placebo softgel (Control Group) starting in the first trimester. SubjectsWe enrolled low-risk pregnancy subjects aged 18 years and above from the obstetrics and gynecology clinic of the University of Utah Hospital. MethodsMaternal macular, skin, and serum carotenoid concentrations were measured using autofluorescence imaging, resonance Raman spectroscopy, and high-performance liquid chromatography, respectively. Infants’ ocular carotenoids and retinal architecture were measured by blue light reflectance imaging and spectral domain optical coherence tomography, respectively. Main Outcome MeasuresChanges in maternal and infant macular pigment, skin, and serum carotenoid status over the study period. Differences in infants’ retinal maturity indicators between the two study groups. ResultsFollowing supplementation, there was a statistically significant increase in maternal macular pigment optical volume (p < 0.001) in the Carotenoid Group relative to the Control Group at all study time points, and there was no detectable maternal ocular carotenoid depletion. Infant skin and serum carotenoids increased significantly in the Carotenoid Group compared to the Control Group. As exploratory endpoints, infants in the Carotenoid Group had a 20% increase in macular pigment optical density (p = 0.242) and more mature foveal parameters compared to those in the Control Group. ConclusionPrenatal carotenoid supplementation significantly increased maternal and infant systemic carotenoids and caused a pattern of increased infant ocular carotenoid status, which may benefit both mothers and their infants’ ocular development and function. This study provides important data to design and power a future multicenter study of prenatal carotenoid supplementation in higher-risk pregnancies.

Intralesional injection of hyaluronic acid compared with verapamil in acute phase of Peyronie’s disease: A prospective randomized clinical trial

ABSTRACT Purpose The aim of this work was to analyze and contrast the effectiveness and safety of intralesional HA in the acute stage of PD with that of verapamil injection. Methods In this prospective, randomized clinical trial, 42 PD-affected, sexually active men between the ages of >18 and 70 participated. Two groups of patients were recruited; group A obtained weekly intralesional treatment with HA for 12 weeks, whereas group B obtained weekly intralesional therapy with verapamil for 12 weeks. Physical examinations and Duplex Doppler ultrasound were performed on all patients. Results The penile curvature was significantly decreased at 12 weeks after therapy in contrast to baseline in group A (34.1 ± 6.77° vs. 24.7 ± 9.72°, p = 0.005), and was significantly decreased at 12 weeks after therapy compared to baseline in group B (36.2 ± 7.43° vs. 30.8 ± 8.63 °, p = 0.047). The decrease in penile curvature at 12 weeks after therapy was noticeably better in group A in contrast to group B (24.7 ± 9.72° vs. 30.8 ± 8.63°, p = 0.038). Conclusion HA is emerging as a valid choice for the treatment of PD in terms of resolution of the acute phase of the disease, and it is plausible to posit that the use of HA may contribute to the stabilization of the disease and decrease the need for the subsequent choice of a possible surgical strategy, with the ability to reduce penile pain and have a stronger impact on penile curvature and patient satisfaction.

Prognostic Significance of the Cribriform Pattern in Prostate Cancer: Clinical Outcomes and Genomic Alterations.

Given the diverse clinical progression of prostate cancer (PC) and the evolving significance of histopathological factors in its management, this study aimed to explore the impact of cribriform pattern 4 (CP4) on clinical outcomes in PC patients and examine its molecular characteristics. This retrospective study analyzed data from The Cancer Genome Atlas (TCGA) database and included PC patients who underwent radical prostatectomy (RP) and had pathology slides available for the assessment of CP4. A multivariable competing risk regression analysis was used to assess the association between CP4 and progression-free survival (PFS) while adjusting for established PC prognostic factors. The frequency of genomic alterations was compared between patients with and without CP4 using the Fisher's exact test. Among the 394 patients analyzed, 129 (32.74%) had CP4. After a median follow-up of 40.50 months (IQR: 23.90, 65.60), the presence of CP4 was significantly associated with lower PFS (AHR, 1.84; 95% CI, 1.08 to 3.114; p = 0.023) after adjusting for covariates. Seven hub genes-KRT13, KRT5, KRT15, COL17A1, KRT14, KRT16, and TP63-had significantly lower mRNA expression levels in patients with CP4 compared to those without. PC patients with CP4 have distinct genomic alterations and are at a high risk of disease progression following RP. Therefore, these patients may benefit from additional post-RP treatments and should be the subject of a prospective randomized clinical trial.