scholarly journals Dexamethasone intracameral drug-delivery suspension for inflammation associated with vitreoretinal surgery

2020 ◽  
Vol 5 (1) ◽  
pp. e000491
Author(s):  
Daniel F Kiernan
Keyword(s):  
Drug Delivery ◽  
Adverse Events ◽  
Anterior Chamber ◽  
Vitreoretinal Surgery ◽  
Postoperative Treatment ◽  
Control Group ◽  
Eye Drops ◽  
Retrospective Case ◽  
Topical Corticosteroids ◽  
Efficacy Outcome

ObjectiveTo evaluate the efficacy of an anterior chamber intracameral dexamethasone (ICD) drug-delivery suspension (Dexycu; EyePoint Pharmaceuticals, Watertown, Massachusetts, USA) providing sustained release of medication following a single application for the treatment of postoperative inflammation in patients undergoing vitreoretinal surgery compared to daily postoperative treatment with topical corticosteroids for up to 1 month.Methods and analysisRetrospective case-matched comparison of patients undergoing initial vitreoretinal surgery by a single surgeon. Patients had a preoperative best-corrected visual acuity of 20/20 to light perception and a variety of vitreoretinal pathologies. 27 eyes of 27 patients received ICD at the time of surgery and were compared with 27 eyes of 27 patients who received daily postoperative corticosteroid eye drops over 4 weeks. The primary efficacy outcome was anterior chamber cell (ACC) clearing (0 cells) in the study eye at postoperative day (POD) 7. Ocular adverse events were assessed through POD 90.ResultsACC clearing at POD 7 was achieved in 67% of eyes in the ICD treatment group and 37% of eyes in the control group treated with topical corticosteroids (p=0.029). No serious ocular adverse events were noted up to POD 90 in either group.ConclusionThe ICD drug-delivery suspension placed in the anterior chamber after vitreoretinal surgery was more effective than topical corticosteroids in treating inflammation occurring 1 week following vitreoretinal surgery and thus may be an alternative to daily corticosteroid drop installation in this patient population.

scholarly journals Diverse cutaneous adverse eruptions caused by anti-programmed cell death-1 (PD-1) and anti-programmed cell death ligand-1 (PD-L1) immunotherapies: clinical features and management

2018 ◽  
Vol 10 ◽  
pp. 175883401775163 ◽  
Author(s):  
John Shen ◽  
Jason Chang ◽  
Melody Mendenhall ◽  
Grace Cherry ◽  
Jonathan W. Goldman ◽  
...  
Keyword(s):  
Cell Death ◽  
Los Angeles ◽  
Programmed Cell Death ◽  
Adverse Events ◽  
Case Series ◽  
Retrospective Case ◽  
Topical Corticosteroids ◽  
Dermatology Clinic ◽  
Case Series Study ◽  
Programmed Cell Death 1

Background: The anti-programmed cell death-1 (PD-1) and anti-programmed cell death ligand-1 (PD-L1) immunotherapies have shown exceptional activity in many cancers. However, these immunotherapies can also result in diverse adverse cutaneous eruptions that need to be better characterized for ongoing management. The objective was to provide clinical and histopathologic descriptions of the variety of cutaneous adverse events seen in patients who received anti-PD-1/PD-L1 treatment and discuss their management. Methods: Patients with advanced cancers in clinical trials at University of California Los Angeles (UCLA), receiving anti-PD-1/PD-L1 treatment between 2012 and 2016 who developed cutaneous eruptions and were evaluated in the dermatology clinic were included in this retrospective case series study. A total of 16 patients were included in this study; of these, five were treated with pembrolizumab alone, two with avelumab alone, eight with nivolumab plus ipilimumab and one with nivolumab plus T-Vec. Of these 16 patients, eight had received systemic chemotherapy, six had received radiotherapy, and one had received trememlimumab prior to the immunotherapies described in this study. Results: Cutaneous eruptions occurred at variable times, from week 1 to 88, with a median of 11.5 weeks; the morphologies included lichenoid, bullous, psoriasiform, macular, morbiliform appearances, and alopecia which were confirmed histopathologically in several of the cases. All cutaneous immune-related adverse events were either grade 1 or 2. Ten patients were treated with topical corticosteroids, and one also received NBUVB. Four patients eventually required systemic steroids. Three required discontinuation of their anti-PD-1/PD-L1 therapy secondary to the cutaneous eruptions. Conclusions: There are several different types of adverse cutaneous morphologies that may be seen with administration of PD-1 and PD-L1 inhibitors. Identifying the patterns of eruption may assist in prompt treatment. Most eruptions could be managed with topical corticosteroids and without discontinuation of the systemic treatment.

scholarly journals Clinical Efficacy of Ultrasound-Mediated Transdermal Lidocaine and Capsaicin Delivery for the Treatment of Allodynia Caused by Herpes Zoster

Pain Medicine ◽  
2020 ◽  
Vol 21 (12) ◽  
pp. 3739-3746
Author(s):  
Yue-e Dai ◽  
Shao-Xing Liu ◽  
Ling Ye ◽  
Yun-Xia Zuo
Keyword(s):  
Drug Delivery ◽  
Herpes Zoster ◽  
Adverse Events ◽  
Emotional Functioning ◽  
Final Analysis ◽  
Intradermal Injection ◽  
Controlled Study ◽  
Control Group ◽  
Group I ◽  
Vas Scores

Abstract Objective To investigate the efficacy of ultrasound-mediated drug delivery for allodynia caused by herpes zoster. Design Unblinded randomized controlled study with two treatment groups and an additional control group. Subjects Patients hospitalized with allodynia caused by herpes zoster were enrolled. Methods Patients were randomly assigned to three groups: ultrasound-mediated transdermal drug delivery (group U), lidocaine intradermal injection (group I), or control group (group C). The primary outcome was pain intensity associated with allodynia, assessed with the visual analog scale (VAS) while brushing the skin with clothing after treatment stimulated allodynia. The secondary outcomes included an emotional functioning score (ES), average gabapentin consumption, and incidence of adverse events of each group. Results Sixty patients were enrolled in the study, but two of them failed to complete the treatment process. Therefore, 58 patients were included in the final analysis. All groups had lower VAS and ES scores after treatment compared with baseline. The VAS scores in groups U and I decreased significantly more than in group C (P < 0.05). Mean VAS scores in group U on days 1, 2, and 3 were lower than in group C (P < 0.01). ES was significantly lower in group U compared with groups I and C after treatment (P < 0.001). Average gabapentin consumption and incidence of adverse events in group C were higher than in the other two groups. Conclusions In this study of treatment of allodynia caused by herpetic zoster, ultrasound-mediated lidocaine and capsaicin delivery provided better pain relief and improved emotional functioning compared with intradermal blockade with local anesthetics.

scholarly journals Inflammatory Response in the Anterior Chamber after Implantation of an Angle-Supported Lens in Phakic Myopic Eyes

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Suphi Taneri ◽  
Saskia Oehler ◽  
Carsten Heinz
Keyword(s):  
Inflammatory Response ◽  
Anterior Chamber ◽  
Anterior Chamber Depth ◽  
Postoperative Treatment ◽  
Eye Drops ◽  
Quick Recovery ◽  
Safe Level ◽  
Laser Flare

Purpose. To evaluate the inflammatory reaction after implantation of an angle-supported foldable acrylic anterior chamber IOL for myopia correction over time.Methods. Adult individuals seeking vision correction with stable myopia >7.0 D were included. Exclusion criteria are anterior chamber depth <2.8 mm, insufficient endothelial cell density, other preexisting ocular conditions, and prior eye surgery. Laser flare photometry and slitlamp examination were performed before and up to 1 year after implantation of an AcrySof Cachet IOL (Alcon Laboratories, Forth Worth, TX, USA). Postoperative treatment comprised antibiotic eye-drops for 5 days and nonsteroidal anti-inflammatory eye-drops (NSAIDs) for 4 weeks.Results. Average laser flare values of 15 consecutive eyes of 15 patients were8.3±9.7preoperatively and19.0±24.2(1 day),24.0±27.5(1 week),17.6±13.4(1 month),14.9±15.4(3 months), and10.0±7.0(1 year) photon counts/ms after implantation, respectively. Slitlamp examination yielded 0 or 1+ cells (SUN classification) in every one eye throughout the follow-up period.Conclusion. Results indicate a low maximum inflammatory response and a quick recovery to a long-term safe level. The use of NSAIDs seems sufficient in routine cases, thus avoiding potential drawbacks of using corticoids.

scholarly journals Mechanistic modeling of ophthalmic drug delivery to the anterior chamber by eye drops and contact lenses

2016 ◽  
Vol 233 ◽  
pp. 139-154 ◽  
Author(s):  
Samuel Gause ◽  
Kuan-Hui Hsu ◽  
Chancellor Shafor ◽  
Phillip Dixon ◽  
Kristin Conrad Powell ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Anterior Chamber ◽  
Contact Lenses ◽  
Mechanistic Modeling ◽  
Eye Drops ◽  
Ophthalmic Drug Delivery ◽  
Ophthalmic Drug

scholarly journals Cap-puncturing mechanism for ophthalmic postoperative antibiotic eye drops: friend or foe?

2019 ◽  
Vol 1 (3) ◽  
pp. 207-213
Author(s):  
Chua Shee Wen ◽  
Yong Meng Hsien ◽  
Malisa Ami ◽  
Rona Asnida Nasaruddin ◽  
Mae-Lynn Catherine Bastion ◽  
...  
Keyword(s):  
Anterior Chamber ◽  
Case Series ◽  
Eye Drops ◽  
Retrospective Case ◽  
Counting Finger ◽  
History Of ◽  
Pars Plana ◽  
Culture Growth ◽  
Systemic Antibiotics ◽  
Gram Positive Cocci

A retrospective case series highlights two cases of postoperative endophthalmitis, in which similar improper technique of puncturing the antibiotic bottle with a nonsterile needle was noted. Patient A, a 65-year-old man with three weeks’ history of uneventful combined cataract and pars plana vitrectomy (PPV) presented with acute painful right eye and vision blurring from 6/12 to 1/60 for two days. Examination showed severe anterior chamber activity and hazy fundal view. B-scan showed dense vitritis. Vitreous sampling revealed gram positive cocci, but no culture growth. Patient B, a 69-year-old man presented with three days’ history of right painful red eye and vision dropped to light perception following an uneventful cataract surgery. Examination showed severe anterior chamber activity with hypopyon, raised intraocular pressure, and no fundal view. B-scan detected dense vitritis with loculation. Vitreous sampling cultured Pseudomonas aeruginosa in Patient B. In both cases, the patients reported piercing the generic topical ciprofloxacin 0.3% bottle tip with a nonsterile needle instead of the prescribed method of using the sterile, inner aspect of the bottle cap. However, the cultures of the bottle contents were negative in both cases. Both patients received intravitreal, topical, and systemic antibiotics and subsequently underwent PPV. Patient A recovered vision to baseline, while Patient B recovered to counting finger vision. The cap-puncturing mechanism for eye drop bottles is designed to maintain the sterility of the contents. However, this may backfire when patients do not understand the prescribed technique. We postulate that this improper technique predisposed the two cases to endophthalmitis. 

Assessment of Craniofacial Morphology in Mouth Breathing Children. A retrospective case-control study

2019 ◽  
Vol 70 (10) ◽  
pp. 3649-3653
Author(s):  
David Angelescu ◽  
Teodora Angelescu ◽  
Meda Romana Simu ◽  
Alexandrina Muntean ◽  
Anca Stefania Mesaros ◽  
...  
Keyword(s):  
Case Control Study ◽  
Case Control ◽  
Craniofacial Morphology ◽  
Respiratory Pattern ◽  
Control Group ◽  
Upper Lip ◽  
Retrospective Case ◽  
Oral Breathing ◽  
Facial Height ◽  
Control Study

The aim of this retrospective case-control study is to determine a possible correlation between breathing mode and craniofacial morphology. The study was carried out in the Department of Pedodontics,Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania. The sample comprised 80 patients, age between 6 and 13 years, which were divided in two groups based on respiratory pattern: control group composed of 38 nasal breathing children and case group composed of 42 oral breathing children. Three quantitative craniofacial parameters were measured from the frontal and lateral photos: facial index, lower facial height ratio and upper lip ratio. The statistical analysis showed a significant higher facial index (p=0.006*) and an increase lower facial height (p=0.033*) for the oral breathers group. No differences in facial morphology were found between genders and age groups, when comparing the data between the same type of respiratory pattern children. Spearman�s rho Correlation show a significant positive correlation (p=0.002*) between facial index and lower facial height and a significant negative correlation between facial index and upper lip (p=0,005*). Long faces children are more likely to develop oral breathing in certain conditions, which subsequently have a negative effect on increasing the lower facial height by altering the postural behavior of mandible and tongue.

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

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
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.

The silent presence of Mycoplasma hominis in patients with prostate cancer

2020 ◽  
Vol 78 (7) ◽  
Author(s):  
Saman Saadat ◽  
Pezhman Karami ◽  
Mohammad Jafari ◽  
Mahdi Kholoujini ◽  
Zahra Rikhtegaran Tehrani ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Mycoplasma Hominis ◽  
Opportunistic Pathogen ◽  
Host Cells ◽  
Prostate Tissue ◽  
Control Group ◽  
P Value ◽  
Retrospective Case ◽  
Formalin Fixed Paraffin Embedded ◽  
Pcr Targeting

ABSTRACT Background Mycoplasma hominis, an opportunistic pathogen in human genitourinary tract, can cause chronic infection in the prostate. Intracellular survival of M. hominis leads to a prolonged presence in the host cells that can affect the cell's biological cycle. In the present study, we aimed to evaluate the frequency of M. hominis DNA in prostate tissue of Iranian patients with prostate cancer (PCa) in comparison to a control group with benign prostatic hyperplasia (BPH). Methods This research was a retrospective case-control study using 61 archived formalin-fixed paraffin-embedded (FFPE) blocks of prostate tissue from patients with PCa and 70 FFPE blocks of patients with BPH. Real-time PCR, targeting two different genes, 16S rRNA and yidC, in the M. hominis genome was performed for all specimens. Results Out of 61 blocks of prostate biopsy from patients with PCa, eight samples (13%) were positive for M. hominis, while the bacterium was not detected in any of the 70 blocks of patients with BPH (P value, 0.002). Conclusions The high frequency of M. hominis in patients with PCa likely shows a hidden role of the organism in prostate cancer during its chronic, apparently silent and asymptomatic colonization in prostate.

An Internet-based health gateway device for interactive communication and automatic data uploading: Clinical efficacy for type 2 diabetes in a multi-centre trial

2016 ◽  
Vol 23 (6) ◽  
pp. 595-604 ◽  
Author(s):  
Jae Hyoung Cho ◽  
Hun-Sung Kim ◽  
Seung Hyun Yoo ◽  
Chang Hee Jung ◽  
Woo Je Lee ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthcare System ◽  
Glucose Control ◽  
Large Scale ◽  
Diabetes Management ◽  
Intervention Group ◽  
Diabetes Control ◽  
Control Group ◽  
Anthropometric Parameters ◽  
Automatic Data

Introduction The aim of this study was to improve the quality of diabetes control and evaluate the efficacy of an Internet-based integrated healthcare system for diabetes management and safety. Methods We conducted a large-scale, multi-centre, randomized clinical trial involving 484 patients. Patients in the intervention group ( n = 244) were treated with the Internet-based system for six months, while the control group ( n = 240) received the usual outpatient management over the same period. HbA1c, blood chemistries, anthropometric parameters, and adverse events were assessed at the beginning of the study, after three months, and the end of the study. Results There were no initial significant differences between the groups with respect to demographics and clinical parameters. Upon six-month follow-up, HbA1c levels were significantly decreased from 7.86 ± 0.69% to 7.55 ± 0.86% within the intervention group ( p < 0.001) compared to 7.81 ± 0.66% to 7.70 ± 0.88% within the control group. Postprandial glucose reduction was predominant. A subgroup with baseline HbA1c higher than 8% and good compliance achieved a reduction of HbA1c by 0.8 ± 1.05%. Glucose control and waist circumference reduction were more effective in females and subjects older than 40 years of age. There were no adverse events associated with the intervention. Discussion This e-healthcare system was effective for glucose control and body composition improvement without associated adverse events in a multi-centre trial. This system may be effective in improving diabetes control in the general population.

EXPRESS: Altering the rehabilitation environment to improve stroke survivor activity (AREISSA): a Phase II trial.

2021 ◽  
pp. 174749302110069
Author(s):  
Heidi Janssen ◽  
Louise Ada ◽  
Sandy Middleton ◽  
Michael Pollack ◽  
Michael Nilsson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Outcomes ◽  
Environmental Enrichment ◽  
Brain Plasticity ◽  
Social Activity ◽  
Stroke Survivor ◽  
Group Differences ◽  
Control Group ◽  
Serious Adverse Events ◽  
Clinical Trial Registration

Background: Environmental enrichment involves organisation of the environment and provision of equipment to facilitate engagement in physical, cognitive and social activity. In animals with stroke, it promotes brain plasticity and recovery. Aims: To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment. Methods: A non-randomised cluster trial with blinded measurement involving people with stroke (n=193) in 4 rehabilitation units was carried out. Feasibility was operationalised as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at 3 months, by an assessor blinded to group. Results: The experimental group (n=91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0 to 19) more time physically, and 6% (95% CI 2 to 10) more time socially active than the control group (n=102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or 3 months nor in clinical outcomes at 3 months. Conclusions: This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes 3 months after stroke do not provide justification for an efficacy trial. Clinical Trial Registration: ANZCTR 12613000796785 Words: 245

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