Needling after XEN gel implant: What’s the efficacy? A 1-year analysis

2020 ◽  
pp. 112067212096344
Author(s):  
Patrícia José ◽  
Filipa Jorge Teixeira ◽  
Rafael Correia Barão ◽  
Paula Sens ◽  
Luís Abegão Pinto
Keyword(s):  
Mitomycin C ◽  
Predictive Factors ◽  
Primary Outcome ◽  
Salvage Procedure ◽  
Significant Drop ◽  
Safety Parameters ◽  
Single Intervention ◽  
Bleb Failure ◽  
Needle Revision

Purpose: To analyse the long-term efficacy and safety of bleb needling in glaucoma patients previously submitted to XEN implantation. Methods: Retrospective, observational study. Charts from patients who underwent XEN gel implant surgery between October 2015 and December 2017 were reviewed. Needling protocol involves use of Mitomycin C 0.2 mg/mL in an operating room. Primary outcome was defined as intraocular pressure (IOP) lowering efficacy at 12 months post-operative. Complete success was defined as a decrease in IOP > 20% and overall value <18 mmHg. Secondary outcomes included safety parameters (both intra and post-operative). Exploratory analysis of predictive factors for success were performed. Statistical analysis was performed using SPSS version 24. Results: About 94 charts were reviewed, with 18 patients (19%) having undergone needle revision. This salvage procedure was performed after 3.3 ± 3.4 months, achieving a mean IOP reduction of 8.3 ± 8.4 mmHg at 12 months after the procedure (pre-needling: 24.0 ± 5.2 mmHg vs 12th month: 13.5 ± 5.9 mmHg, p < 0.0001). Accordingly, success was achieved in 72% (complete success in 61% of cases). Among predictive factors, there was a higher tendency for success in patients on two types of medications or fewer pre-operatively, cases of standalone XEN surgery and patients with a higher IOP difference pre-needling – day 1. No vision-threatening complications were recorded. Conclusion: XEN salvage procedure with mitomycin C is a valid option in early bleb failure. This single intervention had a long-lasting effect on bleb survival, with almost two-thirds achieving long term significant drop-free IOP reduction.

scholarly journals Intracameral Bevacizumab Versus Sub-Tenon’s Mitomycin C as Adjuncts to Trabeculectomy: 3-Year Results of a Prospective Randomized Study

2021 ◽  
Vol 10 (10) ◽  
pp. 2054
Author(s):  
Gerasimos Kopsinis ◽  
Dimitrios Tsoukanas ◽  
Dimitra Kopsini ◽  
Theodoros Filippopoulos
Keyword(s):  
Mitomycin C ◽  
Primary Outcome ◽  
Randomized Study ◽  
Primary Outcome Measure ◽  
Complication Rates ◽  
Filtration Surgery ◽  
Significant Difference ◽  
Exfoliative Glaucoma

Conjunctival wound healing determines success after filtration surgery and the quest for better antifibrotic agents remains active. This study compares intracameral bevacizumab to sub-Tenon’s mitomycin C (MMC) in trabeculectomy. Primary open-angle or exfoliative glaucoma patients were randomized to either bevacizumab (n = 50 eyes) or MMC (n = 50 eyes). The primary outcome measure was complete success, defined as Intraocular Pressure (IOP) > 5 mmHg and ≤ 21 mmHg with a minimum 20% reduction from baseline without medications. Average IOP and glaucoma medications decreased significantly in both groups at all follow-up points compared to baseline (p < 0.001), without significant difference between groups at 3 years (IOP: bevacizumab group from 29 ± 9.4 to 15 ± 3.4 mmHg, MMC group from 28.3 ± 8.7 to 15.4 ± 3.8 mmHg, p = 0.60; Medications: bevacizumab group from 3.5 ± 0.9 to 0.5 ± 1, MMC group from 3.6 ± 0.7 to 0.6 ± 1.1, p = 0.70). Complete success, although similar between groups at 3 years (66% vs. 64%), was significantly higher for bevacizumab at months 6 and 12 (96% vs. 82%, p = 0.03; 88% vs. 72%, p = 0.04, respectively) with fewer patients requiring medications at months 6, 9 and 12 (4% vs. 18%, p = 0.03; 6% vs. 20%, p = 0.04; 8% vs. 24%, p = 0.03, respectively). Complication rates were similar between groups. In conclusion, intracameral bevacizumab appears to provide similar long-term efficacy and safety results as sub-Tenon’s MMC after trabeculectomy.

Long-Term Effects of Postoperative Subconjunctival Injections of Mitomycin-C in the Rabbit Eye

1997 ◽  
Vol 7 (4) ◽  
pp. 340-344 ◽  
Author(s):  
L.E. Pablo ◽  
T. Ramirez ◽  
M. Pueyo ◽  
J.M. Larrosa ◽  
V. Polo ◽  
...  
Keyword(s):  
Mitomycin C ◽  
Subconjunctival Injection ◽  
Long Term Effects ◽  
Rank Tests ◽  
Surgical Sponge ◽  
Operative Evaluation ◽  
Bleb Failure ◽  
Pigmented Rabbits ◽  
Survival Differences

Aim Single or multiple subconjunctival injections of mitomycin-C (MMC) may offer one way of establishing the total dosage of MMC more accurately. The method also allows re-applications later postoperatively. In this experimental, randomized prospective study we compared the effects of a single intraoperative application of MMC at the filtering site and a single postoperative subconjunctival injection of the drug. Methods The left eyes of 32 pigmented rabbits were divided into two groups. In the first group we applied MMC intraoperatively (10) with a 4×1 mm surgical sponge soaked in a MMC solution (0.5 mg/ml). In the second group we injected 0.4 ml of the same solution subconjunctivally (SC) immediately after (conjunctival) suture. Post-operative evaluation was carried out every day during the first week, then every three days until day 58. Survival analyses were done for intraocular pressure (IOP) and bleb failure. Log-rank tests were used to compare survival differences between the groups. Results The IO group showed longer survival parameters than the SC group (p<0.05), both in the control of IOP and as regards blebs. The histological persistence of fistulas was similar. The IO group, however, had a higher incidence of undesirable side effects. Conclusions Our findings suggest IO application of MMC is more effective in reducing fibroblast ingrowth. However, subconjunctival application offers certain advantages such as the possibility of repeating the treatment postoperatively and, therefore, using a smaller initial dose.

832: Optimized Intravesical Mitomycin C Treatment for Superficial Bladder Cancer: Long-Term Follow-Up

2006 ◽  
Vol 175 (4S) ◽  
pp. 268-269 ◽  
Author(s):  
Jessie L. Au ◽  
Robert A. Badalament ◽  
M. Guillaume Wientjes ◽  
Donn C. Young ◽  
Tong Shen ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Mitomycin C ◽  
Superficial Bladder Cancer ◽  
Long Term Follow Up

Novel Targets For Therapeutic Intervention in Inflammatory Bowel Disease. What is the Best Way to Assess the Safety Profile of a Drug?

2019 ◽  
Vol 25 (1) ◽  
pp. 57-63 ◽  
Author(s):  
Clara Yzet ◽  
Stacy S. Tse ◽  
Maia Kayal ◽  
Robert Hirten ◽  
Jean-Frédéric Colombel
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Evaluation Process ◽  
Population Based ◽  
Stage Of Development ◽  
Remission Rates ◽  
Safety Parameters ◽  
Post Marketing ◽  
Inflammatory Bowel

The emergence of biologic therapies has revolutionized the management of inflammatory bowel disease (IBD) by halting disease progression, increasing remission rates and improving long-term clinical outcomes. Despite these well-described benefits, many patients are reluctant to commence therapy due to drug safety concerns. Adverse events can be detected at each stage of drug development and during the post-marketing period. In this article, we review how to best assess the safety parameters of new IBD medications, from the earliest stage of development to population-based registries, with a focus on the special populations often excluded from the evaluation process.

scholarly journals Frailty and hospitalization-associated disability after pneumonia: A prospective cohort study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chan Mi Park ◽  
Wonsock Kim ◽  
Hye Chang Rhim ◽  
Eun Sik Lee ◽  
Jong Hun Kim ◽  
...  
Keyword(s):  
Older Adults ◽  
Primary Outcome ◽  
Long Term Care ◽  
Functional Decline ◽  
Tube Feeding ◽  
Term Care ◽  
Pneumonia Severity ◽  
Frailty Assessment ◽  
Nasogastric Tube Feeding

Abstract Background Pneumonia is a major cause of morbidity and mortality in older adults. The role of frailty assessment in older adults with pneumonia is not well defined. Our purpose of the study was to investigate 30-day clinical course and functional outcomes of pneumonia in older adults with different levels of frailty. Methods A prospective cohort was conducted at a university hospital in Seoul, Korea with 176 patients who were 65 years or older and hospitalized with pneumonia. A 50-item deficit-accumulation frailty index (FI) (range: 0–1; robust < 0.15, pre-frail 0.15–0.24, mild-to-moderately frail 0.25–0.44, and severely frail ≥ 0.45) and the pneumonia severity CURB-65 score (range: 0–5) were measured. Primary outcome was death or functional decline, defined as worsening dependencies in 21 daily activities and physical tasks in 30 days. Secondary outcomes were intensive care unit admission, psychoactive drug use, nasogastric tube feeding, prolonged hospitalization (length of stay > 15 days), and discharge to a long-term care institution. Results The population had a median age 79 (interquartile range, 75–84) years, 68 (38.6 %) female, and 45 (25.5 %) robust, 36 (47.4 %) pre-frail, 37 (21.0 %) mild-to-moderately frail, and 58 (33.0 %) severely frail patients. After adjusting for age, sex, and CURB-65, the risk of primary outcome for increasing frailty categories was 46.7 %, 61.1 %, 83.8 %, and 86.2 %, respectively (p = 0.014). The risk was higher in patients with frailty (FI ≥ 0.25) than without (FI < 0.25) among those with CURB-65 0–2 points (75 % vs. 52 %; p = 0.022) and among those with CURB-65 3–5 points (93 % vs. 65 %; p = 0.007). In addition, patients with greater frailty were more likely to require nasogastric tube feeding (robust vs. severe frailty: 13.9 % vs. 60.3 %) and prolonged hospitalization (18.2 % vs. 50.9 %) and discharge to a long-term care institution (4.4 % vs. 59.3 %) (p < 0.05 for all). Rates of intensive care unit admission and psychoactive drug use were similar. Conclusions Older adults with frailty experience high rates of death or functional decline in 30 days of pneumonia hospitalization, regardless of the pneumonia severity. These results underscore the importance of frailty assessment in the acute care setting.

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