Clinical efficacy and safety in patients treated with teicoplanin with a target trough concentration of 20 μg/mL using a regimen of 12 mg/kg for five doses within the initial 3 days

Abstract Background: A trough concentration (Cmin) ≥20 μg/mL of teicoplanin is recommended for the treatment of serious methicillin-resistant Staphylococcus aureus (MRSA) infections. However available data are limited because it is difficult to attain this target Cmin.Methods: Pharmacokinetics and adverse events were evaluated in all eligible patients. For clinical efficacy, patients who had bacteremia/complicated MRSA infections were analyzed. The primary endpoint for clinical efficacy was an early clinical response at 72–96 h after the start of therapy. Five dosed of 12 mg/kg or 10 mg/kg was administered as an enhanced or conventional high loading dose regimen, respectively. The Cmin was obtained at 72 h after the first dose.Results: Overall, 512 patients were eligible, and 76 patients were analyzed for treatment efficacy. The proportion of patients achieving the target Cmin range (20–40 μg/mL) by the enhanced regimen was significantly higher than for the conventional regimen (75.2% versus 41.0%, p < 0.001). In multivariate analysis, Cmin ≥20 μg/mL was an independent factor for an early clinical response (odds ratio 3.95, 95% confidence interval 1.25–12.53). There was no significant difference in the occurrence of adverse events between patients who did or did not achieve a Cmin ≥20 μg/mL.Conclusion: A target Cmin ≥20 μg/mL might improve early clinical responses during the treatment of difficult MRSA infections using 12 mg/kg teicoplanin for five doses within the initial 3 days.

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Clinical efficacy and safety in patients treated with teicoplanin with a target trough concentration of 20 μg/mL using a regimen of 12 mg/kg for five doses within the initial 3 days

10.21203/rs.3.rs-24637/v2 ◽

2020 ◽

Author(s):

Takashi Ueda ◽

Yoshio Takesue ◽

Kazuhiko Nakajima ◽

Kaoru Ichiki ◽

Kaori Ishikawa ◽

...

Keyword(s):

Adverse Events ◽

Clinical Response ◽

Clinical Efficacy ◽

Trough Concentration ◽

Clinical Evidence ◽

Efficacy And Safety ◽

Target Concentration ◽

Conventional Regimen ◽

Significant Difference ◽

Clinical Responses

Abstract Background: A trough concentration (Cmin) ≥20 μg/mL of teicoplanin is recommended for the treatment of serious methicillin-resistant Staphylococcus aureus (MRSA) infections. However, sufficient clinical evidence to support the efficacy of this target Cmin has not been obtained. Even though the recommended high Cmin of teicoplanin was associated with better clinical outcome, reaching the target concentration is challenging.Methods: Pharmacokinetics and adverse events were evaluated in all eligible patients. For clinical efficacy, patients who had bacteremia/complicated MRSA infections were analyzed. The primary endpoint for clinical efficacy was an early clinical response at 72–96 h after the start of therapy. Five dosed of 12 mg/kg or 10 mg/kg was administered as an enhanced or conventional high loading dose regimen, respectively. The Cmin was obtained at 72 h after the first dose.Results: Overall, 512 patients were eligible, and 76 patients were analyzed for treatment efficacy. The proportion of patients achieving the target Cmin range (20–40 μg/mL) by the enhanced regimen was significantly higher than for the conventional regimen (75.2% versus 41.0%, p < 0.001). In multivariate analysis, Cmin ≥20 μg/mL was an independent factor for an early clinical response (odds ratio 3.95, 95% confidence interval 1.25–12.53). There was no significant difference in the occurrence of adverse events between patients who did or did not achieve a Cmin ≥20 μg/mL.Conclusion: A target Cmin ≥20 μg/mL might improve early clinical responses during the treatment of difficult MRSA infections using 12 mg/kg teicoplanin for five doses within the initial 3 days.

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Impact of cytochrome P450 2C19 polymorphisms on the clinical efficacy and safety of voriconazole: an update systematic review and meta-analysis

10.22541/au.162546769.92188192/v1 ◽

2021 ◽

Author(s):

Ying Zhang ◽

Xu Hao ◽

Kelu Hou ◽

Lei Hu ◽

Jingyuan Shang ◽

...

Keyword(s):

Cytochrome P450 ◽

Adverse Events ◽

Success Rate ◽

Clinical Efficacy ◽

Search Algorithm ◽

Efficacy And Safety ◽

Increased Risk ◽

Significant Difference ◽

The Impact ◽

Cyp2c19 Polymorphisms

Aims: To assess the impact of cytochrome P450 (CYP) 2C19 polymorphisms on the clinical efficacy and safety of voriconazole. Methods: We systematically searched PubMed, EMBASE, CENTRAL, ClinicalTrials.gov, and three Chinese databases from their inception to March 18, 2021 using a predefined search algorithm to identify relevant studies. Studies that reported voriconazole-treated patients and information on CYP2C19 polymorphisms were included. The efficacy outcome was success rate. The safety outcomes included overall adverse events, hepatotoxicity and neurotoxicity. Results: A total of 20 studies were included. Intermediate metabolizers (IMs) and Poor metabolizers (PMs) were associated with increased success rates compared with normal metabolizers (NMs) (risk ratio (RR): 1.18, 95% confidence interval (CI): 1.03~1.34, I2=0%, p=0.02; RR: 1.28, 95%CI: 1.06~1.54, I2=0%, p=0.01). PMs were at increased risk of overall adverse events in comparison with NMs and IMs (RR: 2.18, 95%CI: 1.35~3.53, I2=0%, p=0.001; RR: 1.80, 95% CI: 1.23~2.64, I2=0%, p=0.003). PMs demonstrated a trend towards an increased incidence of hepatotoxicity when compared with NMs (RR: 1.60, 95%CI: 0.94~2.74, I2=27%, p=0.08), although there was no statistically significant difference. In addition, there was no significant association between CYP2C19 polymorphisms and neurotoxicity. Conclusions: IMs and PMs were at a significant higher success rate in comparison with NMs. PMs were significantly associated with an increased incidence of all adverse events compared with NMs and IMs. Researches are expected to further confirm these findings. Additionally, the relationship between hepatotoxicity and CYP2C19 polymorphisms deservers clinical attention.

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Single-Blind, Prospective, Randomized Study of Cefmetazole and Cefoxitin in the Treatment of Postcesarean Endometritis

Infectious Diseases in Obstetrics and Gynecology ◽

10.1155/s1064744995000263 ◽

1995 ◽

Vol 3 (1) ◽

pp. 28-33 ◽

Cited By ~ 4

Author(s):

Ashwin Chatwani ◽

Mark Martens ◽

David A. Grimes ◽

Molly Chatterjee ◽

Melvin Noah ◽

...

Keyword(s):

Side Effects ◽

Adverse Events ◽

Cesarean Delivery ◽

Clinical Efficacy ◽

Randomized Study ◽

Prospective Randomized Study ◽

Efficacy And Safety ◽

Cure Rate ◽

Clinical Responses ◽

Single Blind

Objective: The purpose of this study was to compare the clinical efficacy and safety of cefmetazole given by IV push with that of parenterally administered cefoxitin for the treatment of endometritis following cesarean delivery.Methods: In a single-blind, multicenter, prospective, randomized study, 355 patients with endometritis after cesarean delivery were enrolled and received medication. Administered was either cefmetazole sodium, 2 g by IV push over 1 min q 8 h, or cefoxitin sodium, 2 g IV q 6 h in a 2:1 ratio. The patients were followed for clinical responses and side effects.Results: The cure rate for cefmetazole was 89% and for cefoxitin it was 79% (P = 0.006). The adverse events were similar in both groups.Conclusions: Cefmetazole was significantly more effective than cefoxitin in the treatment of endometritis following cesarean delivery.

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Clinical efficacy and safety following dose tapering of ciclosporin in cats with hypersensitivity dermatitis

Journal of Feline Medicine and Surgery ◽

10.1177/1098612x15602523 ◽

2016 ◽

Vol 18 (11) ◽

pp. 898-905 ◽

Cited By ~ 2

Author(s):

Elizabeth S Roberts ◽

Tiffany Tapp ◽

Ann Trimmer ◽

Linda Roycroft ◽

Stephen King

Keyword(s):

Adverse Events ◽

Clinical Response ◽

Clinical Efficacy ◽

Safety Profile ◽

Therapeutic Response ◽

Clinical Pathology ◽

Efficacy And Safety ◽

Dosing Frequency ◽

Dosing Regimens ◽

Physical Examinations

Objectives This study was designed to evaluate the efficacy and safety of reducing ciclosporin (CsA) dosing frequency from daily to every other day (EOD) or twice a week (TW) according to clinical response in cats with hypersensitivity dermatitis (HD) and treated with CsA. Methods One hundred and ninety-one cats with HD were given 7 mg/kg CsA daily for at least 4 weeks. Depending on clinical response, the dosing frequency was tapered from daily to EOD over the next 4 weeks and further to TW for an additional 4 weeks. Safety was evaluated through physical examinations, clinical pathology and the monitoring of adverse events (AEs). Results The majority of cats were able to have their dose of CsA tapered to either EOD (15.5%) or TW (62.9%) according to the clinical response. Observed AEs were most frequently mild and self-limiting vomiting and diarrhea. A higher percentage of AEs occurred with daily administration (73%) compared with other dosing regimens (27%). Conclusions and relevance Following 4 weeks of daily dosing at 7 mg/kg, CsA may be tapered to EOD or TW while maintaining the desired therapeutic response in cats with HD. Additionally, CsA appears to be well tolerated with fewer AEs at EOD or TW dosing. Establishing the lowest effective dosing frequency of CsA improves the drug’s safety profile.

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Vancomycin loading dose is associated with increased early clinical responses without attainment of initial target trough concentration at a steady state in patients with normal renal function

10.21203/rs.2.10949/v1 ◽

2019 ◽

Author(s):

Takashi Ueda ◽

Yoshio Takesue ◽

Kazuhiko Nakajima ◽

Kaoru Ichiki ◽

Kaori Ishikawa ◽

...

Keyword(s):

Steady State ◽

Clinical Response ◽

Trough Concentration ◽

Clinical Success ◽

Quality Data ◽

Loading Dose ◽

Coagulase Negative Staphylococci ◽

Methicillin Resistant ◽

Significant Difference ◽

Clinical Responses

Abstract Background Vancomycin therapeutic guidelines suggest a loading dose of 25–30 mg/kg for seriously ill patients. However, high-quality data to guide the use of loading dose are lacking. Evaluate whether a loading dose 1) achieves a target trough concentration (Cmin) at steady state and 2) improves early clinical responses. Methods Patients with an estimated glomerular filtration rate ≥90 mL/min/1.73 m2 were included. A loading dose of 25 mg/kg vancomycin followed by 15 mg/kg twice daily was compared with traditional dosing. A Cmin sample was obtained before the fifth dose. An early clinical response 48–72 h after the start of therapy and clinical success at end of therapy (EOT) was evaluated in patients with methicillin-resistant Staphylococcus aureus (MRSA), methicillin-resistant coagulase-negative Staphylococci, or Enterococcus faecium. Results There was no significant difference in Cmin between the regimen with and without a loading dose (median: 10.4 µg/mL and 10.2 µg/mL, P=0.538). Proportions of patients achieving 10–20 µg/mL and 15–20 µg/mL were 56.9% and 5.6%, respectively, in patients with a loading dose. Although there was no significant difference in success rate at EOT between groups, loading dose was associated with increased early clinical responses for all infections [adjusted odds ratio (OR): 4.829, 95% confidence interval (CI): 1.441–16.188] and MRSA infections (OR: 10.851, 95% CI: 1.701–69.233). Increased adverse events were not observed with the loading dose. Study limitations included no Cmin measurements within 24 hours, and the inclusion of less critically ill patients. Conclusions Although the loading dose did not achieve optimal Cmin at steady state, a higher early clinical response was obtained compared with traditional dosing.

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Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

Reviews on Recent Clinical Trials ◽

10.2174/1574887114666191105152404 ◽

2020 ◽

Vol 15 (1) ◽

pp. 34-47 ◽

Cited By ~ 1

Author(s):

Muhammed Rashid ◽

Madhan Ramesh ◽

K. Shamshavali ◽

Amit Dang ◽

Himanshu Patel ◽

...

Keyword(s):

Prostate Cancer ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Quality Assessment ◽

Cochrane Library ◽

Control Group ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

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POS0630 COMPARISON OF THE EFFICACY AND SAFETY OF ORIGINAL AND BIOSIMILAR ADALIMUMAB MOLECULES IN CHILDHOOD RHEUMATIC DISEASES

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.2979 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 553.1-553

Author(s):

K. Ulu ◽

F. Demir ◽

T. Coşkuner ◽

Ş. Çağlayan ◽

B. Sözeri

Keyword(s):

Adverse Events ◽

Disease Activity ◽

Rheumatic Diseases ◽

Behcet’S Disease ◽

Behçet's Disease ◽

Inactive Disease ◽

Efficacy And Safety ◽

Serious Adverse Events ◽

Significant Difference ◽

Abp 501

Background:The TNF-α inhibitor adalimumab is a biological disease modifying anti-rheumatic drug (bDMARD) that has been used in different rheumatic diseases with a resistant course. ABP-501 is a biosimilar product (BP) of adalimumab, recently approved by the FDA and EMA. To our knowledge, there is no study assess the efficacy and safety of these two molecules on pediatric patients.Objectives:We aimed to compare the efficacy and safety of the original and biosimilar adalimumab (ABP-501) molecules in childhood rheumatic diseases.Methods:This non-interventional, retrospective, single-centre analysis carried out in Umraniye Training and Resrach Hospital, Pediatric Rheumatology Clinic, Istanbul, Turkey. The study group consisted of patients who were followed due to chronic rheumatic disease between January 1, 2016 and June 1, 2020, and received reference or biosimilar adalimumab therapy for at least three months. Demographic and clinical data of patients were collected at baseline, 3rd, 6th, and 12th months of treatment. Disease activity assessment was made with JADAS-27 in JIA patients, with SUN criteria in uveitis patients, and with Behçet’s Disease Activity Index in BD patients. Efficacy and safety of treatments were compared between reference and biosimilar adalimumab groups.Results:A total of 89 patients (65 with original and 24 with biosimilar molecule) treated with adalimumab, were included in the study. There were 45 female and 44 male in the study, and the median age at the initiation of the adalimumab was 166 months (min-max: 36-231). Of the 89 patients evaluated, the primary diagnoses of 62 were juvenile idiopathic arthritis, 13 were idiopathic uveitis, eight were Behçet’s disease, three were Blau syndrome, two were chronic recurrent multifocal osteomyelitis and one was Vogt-Koyanagi-Harada syndrome. 63 of the patients were biologic-naïve, and 13 were switched from etanercept, 11 from infliximab, and two from other bDMARDs. The median exposure time of adalimumab was 16 months (min-max:3-70) in RP and 14.5 months (min-max: 3-23) in BP. All patients had active disease before treatment. In the group treated with RP, inactive disease was achieved in 60%, 76.6% and 87.2% of the patients at the 3rd, 6th and 12th months, respectively. Also, inactive disease was achieved in 62.5%, 78.2% and 78.2% of the patients at the 3rd, 6th and 12th months in the group treated with BP, respectively. There was no statistically significant difference in efficacy between the groups at the 3rd, 6th and 12th months (p=0.83, 0.07 and 0.32). Serious adverse events were seen in one patient in each groups (lymphoma in RP group, tuberculous meningitis in BP group). Non-serious adverse events were observed in eight patients (12.3%) in the RP group and in two patients (8.3%) in the BP group, without statistically significant difference between groups (p=0.86).Conclusion:No significant difference was observed between the biosimilar adalimumab ABP-501 and RP adalimumab in terms of efficacy and safety.References:[1]Renton, William D et al. Pediatr Rheumatol Online J. 2019;17(1):67.[2]Lovell DJ, Ruperto N, Goodman S, et al. N Engl J Med. 2008;359(8):810-820.[3]Kingsbury, Daniel J et al. Clin Rheumatol 2014;33(10):1433-41.Disclosure of Interests:None declared

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Efficacy and safety of Finasteride (5 alpha-reductase inhibitor) monotherapy in patients with benign prostatic hyperplasia: A critical review of the literature

Archivio Italiano di Urologia e Andrologia ◽

10.4081/aiua.2019.4.205 ◽

2020 ◽

Vol 91 (4) ◽

pp. 205-210

Author(s):

Gian Maria Busetto ◽

Francesco Del Giudice ◽

Daniele D'Agostino ◽

Daniele Romagnoli ◽

Andrea Minervini ◽

...

Keyword(s):

Clinical Trials ◽

Benign Prostatic Hyperplasia ◽

Adverse Events ◽

Clinical Efficacy ◽

Critical Review ◽

Reductase Inhibitor ◽

Prostate Volume ◽

Prostatic Hyperplasia ◽

Urinary Flow ◽

Efficacy And Safety

Background: Combination therapy with 5 alpha-reductase inhibitor (5-ARI) and alpha-blocker can be considered as a gold standard intervention for medical management of lower urinary tract symptoms related to benign prostatic hyperplasia (LUTS/BPH). On the other hand, 5-ARI monotherapy and in particular Finasteride alone is currently getting focus of attention especially due to lack of systematic reviews investigating efficacy outcomes and/or adverse events associated. Objectives: Aim of the present critical review was to analyze current knowledge of clinical efficacy and incidence of adverse events associated with 5-ARI treatment for LUTS/BPH. Materials and methods: A systematic review of clinical trials of the literature of the past 20 years was performed using database from PubMed, Cochrane Collaboration and Embase. A total of 8821 patients were included in this study and inclusion criteria for studies selection were: data from randomized clinical trials (RCTs) focusing their attention on the clinical role of Finasteride monotherapy for symptomatic BPH. Parameters of research included prostate specific antigen (PSA), prostate volume (PV), International Prostate Symptom Score (IPPS), postvoid residual urine (PVR), voiding symptoms of IPSS (voiding IPSS), maximum urinary flow rate (Qmax), and adverse events (AEs). Results: Overall 12 original articles were included and critically evaluated. Sample sizes of patient actively treated with finasteride varied from 13 to 1524 cases analyzed in a single study. Follow-up after treatments ranged from 3 to 54 months. The effect of finasteride in reducing prostate volume (PV) was moderate (standardized mean difference (SMD) effect between 0.5 to 0.8 for all trials evaluable) while the effect on IPSS score and Qmax was considered significant (SMD in the 0.2 to 0.5 variation range). No severe AEs and/or psychiatric disorders were retrieved among the studies. Sexual health dysfunctions were significantly influenced by finasteride therapy when compared with placebo treated patients. Conclusions: Although significant clinical benefits of finasteride monotherapy were demonstrated, the effective size of the available reports included in the analysis is limited. Additional head-to-head studies would be needed to re-evaluate clinical efficacy and safety of 5-ARI in combination or not with alpha blockers.

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Efficacy and Safety of Aidi Injection Combined with Transcatheter Arterial Chemoembolization on Primary Hepatic Carcinoma: A Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/6376429 ◽

2018 ◽

Vol 2018 ◽

pp. 1-14

Author(s):

Weihao Chen ◽

Yurong Wang ◽

Qiuer Liang ◽

Yunfei Cai ◽

Xudong Chen ◽

...

Keyword(s):

Clinical Response ◽

Transcatheter Arterial Chemoembolization ◽

Response Rate ◽

Clinical Response Rate ◽

Efficacy And Safety ◽

Hepatic Carcinoma ◽

Primary Hepatic Carcinoma ◽

Significant Difference ◽

Aidi Injection ◽

Arterial Chemoembolization

Objectives. To evaluate the efficacy and safety of Aidi injection (ADI) combined with transcatheter arterial chemoembolization (TACE) for primary hepatic carcinoma (PHCC). Methods. We conducted a literature search in EMBASE, PubMed, CENTRAL, MEDLINE, CNKI, Wanfang, and VIP databases from the earliest possible year to April 2018. Randomized controlled trials (RCTs) involving ADI combined with TACE versus TACE alone for patients with PHCC were included. The Cochrane Risk of Bias tool was applied for quality assessment. Results. 22 studies involving 1611 participants were included. The clinical response rate (RR = 1.28, 95% CI: 1.17-1.40; P < 0.00001), KPS score (RR = 1.78, 95% CI: 1.59-2.00; P < 0.00001), survival rate (RR = 1.27, 95% CI: 1.16-1.39; P < 0.00001), immune function (MD = 1.24, 95% CI: 0.98-1.51; P < 0.00001), and adverse effects (RR = 0.62, 95% CI: 0.57-0.68; P < 0.00001) of ADI plus TACE showed significant difference when compared with TACE alone. Conclusions. ADI combined with TACE in the treatment of PHCC improved the clinical response rate and safety compared to TACE alone. However, due to poor methodological quality of many of the included RCTs, more rigorously designed and large-scale RCTs are warranted to examine this beneficial effect in the future.

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Efficacy and safety of Nd:YAG laser vitreolysis for symptomatic vitreous floaters: A randomized controlled trial

European Journal of Ophthalmology ◽

10.1177/1120672120968762 ◽

2020 ◽

pp. 112067212096876

Author(s):

Gustavo D Ludwig ◽

Henrique Gemelli ◽

Guilherme M Nunes ◽

Pedro D Serracarbassa ◽

Márgara Zanotele

Keyword(s):

Adverse Events ◽

Contrast Sensitivity ◽

Nd:Yag Laser ◽

Visual Disturbance ◽

Control Group ◽

Efficacy And Safety ◽

Yag Laser ◽

Vitreous Floaters ◽

Significant Difference ◽

Laser Group

Background: Vitreous floaters are a common and inconvenient phenomena. This study aims to examine the efficacy and safety in treating vitreous floaters using Nd:YAG laser vitreolysis. Methods: In this prospective double-blinded randomized clinical trial 24 eyes of twenty-four patients were randomized into intervention with YAG laser vitreolysis and control groups. Primary outcomes were visual disturbance on a 10-point scale, qualitative changes in a 4-level scale, contrast sensitivity measured with the Pelli-Robson table and the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary results included objective change in vitreous opacities, best-corrected visual acuity (BCVA), variation in intraocular pressure (IOP) and other adverse events. Results: Twenty-one patients (21 eyes; 5 male, 16 female) were enrolled in this study (mean age 62 ± 7.9 years), three were lost during follow-up. In the YAG laser group, the 10-point visual disturbance score improved a mean of 4.7 points ( p < 0.001) compared to the control group that improved 2.1 ( p = 0.09). The YAG laser group reported greater subjectively symptomatic improvement (77%) than controls (25%). NEI VFQ-25 revealed improved general vision (75.8 versus 59.2; p = 0.037) and in mental health at 6 months (84.3 versus 70.3; p = 0.048). There was no significant difference in contrast sensitivity ( p = 0.848) and in IOP ( p = 0.505). No differences in adverse events between groups were identified. Conclusion: Vitreolysis with Nd:YAG laser improves visual results in patients with symptomatic vitreous floaters, without adverse events considered clinically relevant. Other trials with a larger number of participants are required to corroborate these results.

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