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.

Trabeculectomy with mitomycin C alone or coupled with intracamerular bevacizumab? A 2-year comparative study

2021 ◽  
pp. bjophthalmol-2021-319039
Author(s):  
Patrícia José ◽  
Filipa Jorge Teixeira ◽  
Rafael Barão ◽  
David Cordeiro Sousa ◽  
Raquel Esteves Marques ◽  
...  
Keyword(s):  
Comparative Study ◽  
Mitomycin C ◽  
Primary Outcome ◽  
Open Angle Glaucoma ◽  
Complication Rates ◽  
Success Rates ◽  
Surgical Success ◽  
Significant Difference ◽  
Registration Number

PurposeTo compare outcomes of primary trabeculectomy using either mitomycin C (MMC) alone versus MMC augmented with intracamerular bevacizumab in patients with open-angle glaucoma.MethodsRetrospective, cohort, two-centre, comparative study. Patients’ data were screened between October 2015 and March 2019, with inclusion requiring a minimum follow-up of 24 months. Primary outcome was intraocular pressure (IOP) lowering at 24 months, with surgical success defined with different maximum IOP targets (≤18, ≤16 and ≤14 mm Hg) and at least 30% reduction and higher than 5 mm Hg. Absolute success was achieved if no IOP-lowering medication was needed and a qualified success if otherwise. Safety outcomes were analysed.ResultsA total of 110 eyes underwent trabeculectomy with MMC, 51 of these combined with intracamerular bevacizumab. Both strategies were effective in terms of IOP lowering (baseline vs 2 years postoperatively: 24.4 (8.0) mm Hg vs 12.1 (5.3) mm Hg in the MMC group; 25.1 (8.7) vs 10.8 (3.8) mm Hg in the MMC+bevacizumab group; p<0.001 in both comparisons). The MMC+bevacizumab group had a significant difference towards higher efficacy on absolute success rates at all targets (IOP≤14 or ≤16 or ≤18 mm Hg; p=0.010, p=0.039 and p=0.007, respectively). The large majority (93%) of the MMC+bevacizumab group was drop-free at 24 months, and 41% had IOP below 10 mm Hg. Complication rates were low and similar between groups, with no systemic adverse events.ConclusionsIntracamerular bevacizumab in MMC-augmented primary trabeculectomy increases the chances of obtaining low IOP outcomes. This strategy may be useful when planning for surgeries aiming at target pressures in the low teens.Trial registration numberISRCTN93098069.

scholarly journals Transpancreatic biliary sphincterotomy for biliary access is safe also on a long-term scale

2020 ◽  
Vol 35 (1) ◽  
pp. 104-112
Author(s):  
Vilja Koskensalo ◽  
Marianne Udd ◽  
Mia Rainio ◽  
Jorma Halttunen ◽  
Matias Sipilä ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
University Hospital ◽  
Long Term Results ◽  
Biliary Duct ◽  
Complication Rates ◽  
Biliary Sphincterotomy ◽  
Significant Difference ◽  
Upper Abdominal

Abstract Background Transpancreatic biliary sphincterotomy (TPBS) is an advanced cannulation method for accessing common bile duct (CBD) in endoscopic retrograde cholangiopancreatography (ERCP). If CBD cannulation is difficult, an endoscopist can open the septum between the pancreatic and biliary duct with a sphincterotome to gain access. Long-term results of this procedure are unclear. We wanted to evaluate the short- and long-term complications of TPBS on patients with native papilla and benign indication for ERCP. Patients and Methods ERCPs performed in Helsinki University Hospital between 2007 and 2013 were reviewed. The study group comprised 143 consecutive patients with TPBS and 140 controls (CG). Data were collected from patient records and a phone survey was performed as a follow-up ≥ 4 years after the index ERCP. Results Post-ERCP pancreatitis (PEP) developed in seven patients (4.9%) in TPBS and one patient (0.7%) in CG (p = 0.067). The rates of other acute complications were similar between the groups. ERCP ended with no access to CBD in four cases (2.8%) in TPBS. The median length of follow-up was 6 years in TPBS and 7 years in CG. During this period, three patients (2.1%) in TPBS and six patients (4.3%) in CG suffered from acute pancreatitis (AP) (p = 0.238). One (0.7%) patient in CG and none in TPBS developed chronic pancreatitis (CP). Abdominal pain was suffered by ten patients (6.9%) in TPBS and twelve patients (8.6%) in CG daily, whereas by six patients (4.2%) in TPBS and twelve patients (8.6%) in CG weekly. Conclusion TPBS is a useful procedure, with acceptable complication rates. No significant difference occurred between the groups when evaluating the short-term or long-term complications with a follow-up period of four to 10 years. Additionally, no significant differences occurred in upper abdominal pain, episodes of AP, or development of CP.

One-year follow-up of the XEN® implant with mitomycin-C in pseudoexfoliative glaucoma patients

2018 ◽  
Vol 29 (3) ◽  
pp. 309-314 ◽  
Author(s):  
Ana Ibáñez-Muñoz ◽  
Víctor Santiago Soto-Biforcos ◽  
María Chacón-González ◽  
Oscar Rúa-Galisteo ◽  
Alexandra Arrieta-Los Santos ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Mitomycin C ◽  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Pressure Reduction ◽  
Pseudoexfoliative Glaucoma ◽  
Intraocular Pressure Reduction ◽  
Pressure Lowering ◽  
One Year

Purpose: To evaluate the intraocular pressure–lowering effect, the safety profile, and the success rate of the XEN45 Gel Stent (Allergan, Dublin, Ireland) in patients with pseudoexfoliative glaucoma. Methods: Retrospective study conducted on patients with pseudoexfoliative glaucoma, with or without cataract, who underwent XEN45 implantation surgery with subconjunctival mitomycin-C and had a minimum postoperative follow-up period of 12 months. The primary outcome measure was intraocular pressure reduction at 1 year as compared to baseline. Complete success was defined as a postoperative intraocular pressure reduction of ⩾20% from preoperative baseline at 12 months without any glaucoma medications. Qualified success was defined as a postoperative intraocular pressure reduction of ⩾20% at 12 months with medications. Results: Of the 24 screened patients, 21 eyes of 20 patients met the inclusion/exclusion criteria and were included in the study. A total of 13 (62%) eyes underwent XEN alone surgery and 8 (38%) eyes had combined XEN + cataract surgery. Mean intraocular pressure was significantly reduced from 21.1 (3.8) mmHg at baseline to 15.2 (3.9) mmHg at 1 year, p < 0.001. Mean antiglaucoma medications dropped from 2.95 (0.97) preoperatively to 1.23 (1.22) at month 12 (p < 0.001). Of the 21 eyes included in the study, 18 (85.7%) were considered as success, 6 (28.6%) as complete success, and 12 (57.1%) as qualified success. Five eyes required needling revision. Complications included uveitis, choroidal detachment, hyphema, and cystoid macular edema in 2, 1, 1, and 1 eye, respectively. Conclusion: XEN45 Gel Stent implant significantly reduced the intraocular pressure and the number of antiglaucoma medications in patients with pseudoexfoliative glaucoma.

scholarly journals Comparison of Subconjunctival Mitomycin C and 5-Fluorouracil Injection for Needle Revision of Early Failed Trabeculectomy Blebs

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Wei Liu ◽  
Jianrong Wang ◽  
Miaomiao Zhang ◽  
Yuan Tao ◽  
Yan Sun
Keyword(s):  
Mitomycin C ◽  
Randomized Study ◽  
Prospective Randomized Study ◽  
Rank Test ◽  
Complication Rates ◽  
Success Rates ◽  
Log Rank Test ◽  
The Mean ◽  
Needle Revision

Background. To compare the efficacy of needle revision with 5-fluorouracil (5-FU) and mitomycin C (MMC) on dysfunctional filtration blebs shortly after trabeculectomy.Methods. It is a prospective randomized study comparing needle revision augmented with MMC or 5-FU for failed trabeculectomy blebs.Results. To date 71 patients (75 eyes) have been enrolled, 40 eyes in the MMC group and 35 in the 5-FU group. 68 patients (72 eyes) have completed 12-month follow-up, 38 eyes in the MMC group and 34 in the 5-FU group. The mean IOP before and that after needle revision in the MMC group were26.5±4.3 mmHg and11.3±3.4 mmHg, respectively (P<0.05), and in the 5-FU group were27.1±3.8 mmHg and10.9±3.4 mmHg, respectively (P<0.05). At 12-month follow-up, complete success rates were 57.5% for MMC group and 34.3% for 5-FU group (P=0.042; log-rank test) and 75% and 60% (P=0.145; log-rank test), respectively, for the qualified success. Complication rates between the two groups were not statistically different (P>0.05).Conclusions. Needle revision and subconjunctival MMC injection were more effective than needling and subconjunctival 5-FU injection for early dysfunctional filtration blebs after trabeculectomies.

Long-term follow-up after bilateral percutaneous epiphysiodesis around the knee to reduce excessive predicted final height

2017 ◽  
Vol 103 (3) ◽  
pp. 219-223 ◽  
Author(s):  
Wesley J Goedegebuure ◽  
Frank Jonkers ◽  
Annemieke M Boot ◽  
Willie M Bakker-van Waarde ◽  
Vera van Tellingen ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Final Height ◽  
Treated Group ◽  
Knee Function ◽  
Tall Stature ◽  
Complication Rates ◽  
Significant Difference ◽  
Close Relatives

ContextPercutaneous epiphysiodesis (PE) around the knee to reduce predicted excessive final height. Studies until now included small numbers of patients and short follow-up periods.Objective and designThis Dutch multicentre, long-term, retrospective, follow-up study aimed to assess adult height (AH), complications, knee function and patient satisfaction after PE. The primary hypothesis was that PE around the knee in constitutionally tall boys and girls is an effective treatment for reducing final height with low complication rates and a high level of patient satisfaction.Participants77 treated adolescents and 60 comparisons.InterventionPercutaneous epiphysiodesis.OutcomeAH, complications, knee function, satisfaction.ResultsIn the PE-treated group, final height was 7.0 cm (±6.3 cm) lower than predicted in boys and 5.9 cm (±3.7 cm) lower than predicted in girls. Short-term complications in file search were seen in 5.1% (three infections, one temporary nerve injury), one requiring reoperation. Long-term complications in file search were seen in 2.6% (axis deformity 1.3%, prominent head of fibula 1.3%). No significant difference in knee function was found between treated cases and comparisons. Satisfaction was high in both the comparison and PE groups; most patients in the PE group recommended PE as the treatment for close relatives with tall stature.ConclusionPE is safe and effective in children with predicted excessive AH. There was no difference in patient satisfaction between the PE and comparison group. Careful and detailed counselling is needed before embarking on treatment.

scholarly journals Recurrence and Complication Rates among Current Pterygium Treatment Techniques: Pre-operative Subpterygeal Mitomycin-C Injection, Intraoperative Mitomycin C Application and Pterygium Excision with Conjunctival Autograft

2020 ◽  
Vol 54 (5) ◽  
Author(s):  
Archimedes L.D. Agahan ◽  
Theresa Gladiola B. Merca ◽  
Jose V. Tecson III ◽  
Minnette A. Panganiban
Keyword(s):  
Mitomycin C ◽  
Tertiary Hospital ◽  
Controlled Clinical Trial ◽  
Complication Rates ◽  
Recurrence Rates ◽  
Conjunctival Autograft ◽  
Treatment Techniques ◽  
Significant Difference ◽  
Pterygium Excision

Objective. This study aims to determine recurrence and complication rates among patients who underwent threecurrent pterygium treatment techniques: preoperative subpterygeal injection of mitomycin C, intraoperativeapplication of mitomycin with pterygium excision and pterygium excision with conjunctival autograft. Methods. This is a randomized controlled clinical trial in a tertiary hospital. We included patients with diagnosedprimary pterygium and who underwent either: A = pre-operative injection of 0.02% mitomycin C one month prior topterygium excision; B = pterygium excision with intraoperative mitomycin C application; or C = pterygium excisionwith conjunctival autograft. Results. We included 111 patients: a total of 120 eyes randomized to 3 groups (A, B, C) at 40 eyes per group.After 24 months of follow-up, there was no significant difference in the recurrence rates among the groups (6/40[15%] in groups A and B and 2/40 cases [5%] in group C; P=0.29). No complications were noted in groups B and C,while 1 case of scleral thinning was noted in group A. There was no significant difference in the complication ratesamong the three procedures (P=1.00). Conclusion. There were no significant differences in the recurrence and complication rates among the three techniques. Careful patient selection and follow-up are recommended to prevent complications such as scleral thinning.

scholarly journals Long-Term Impact of Cyclosporin Reduction with MMF Treatment in Chronic Allograft Dysfunction: REFERENECE Study 3-Year Follow Up

2010 ◽  
Vol 2010 ◽  
pp. 1-11 ◽  
Author(s):  
L. Frimat ◽  
E. Cassuto-Viguier ◽  
F. Provôt ◽  
L. Rostaing ◽  
B. Charpentier ◽  
...  
Keyword(s):  
Kidney Function ◽  
Randomized Study ◽  
Control Group ◽  
Serious Adverse Events ◽  
Transplant Patients ◽  
Long Term Effect ◽  
Significant Difference ◽  
Long Term Impact

Calcineurin inhibitor (CNI) toxicity contributes to chronic allograft nephropathy (CAN). In the 2-year, randomized, study, we showed that 50% cyclosporin (CsA) reduction in combination with mycophenolate mofetil (MMF) treatment improves kidney function without increasing the risk for graft rejection/loss. To investigate the long-term effect of this regimen, we conducted a follow up study in 70 kidney transplant patients until 5 years after REFERENCE initiation. The improvement of kidney function was confirmed in the MMF group but not in the control group (CsA group). Four graft losses occurred, 2 in each group (graft survival in the MMF group 95.8% and 90.9% in control group). One death occurred in the control group. There was no statistically significant difference in the occurrence of serious adverse events or acute graft rejections. A limitation is the weak proportion of patient still remaining within the control group. On the other hand, REFERENCE focuses on the CsA regimen while opinions about the tacrolimus ones are still debated. In conclusion, CsA reduction in the presence of MMF treatment seems to maintain kidney function and is well tolerated in the long term.

Outcome of trabeculectomy with Ologen versus Mitomycin C: A comparative prospective study in Bangladesh

2018 ◽  
Vol 29 (2) ◽  
pp. 183-188 ◽  
Author(s):  
Bipul Kumer De Sarker ◽  
Sadiq M Abdullahi ◽  
Zafrul Hassan ◽  
Jahangir Kabir ◽  
Sarat Badmus ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Prospective Study ◽  
Mitomycin C ◽  
Primary Outcome Measure ◽  
Glaucoma Medication ◽  
Significant Difference ◽  
Primary Glaucoma ◽  
A Prospective Study ◽  
Comparative Prospective Study

Aims: To compare the efficacy and safety of trabeculectomy with Ologen versus Mitomycin C in primary glaucoma Materials and methods: This is a prospective study of patients aged 18 years and above, diagnosed with primary glaucoma randomised to having trabeculectomy with Ologen or Mitomycin C. The primary outcome measure was success of trabeculectomy defined as intraocular pressure >5 mmHg but ≤21 mmHg. Complete success was defined as intraocular pressure achieved without anti-glaucoma medication and qualified success was defined as intraocular pressure achieved with additional anti-glaucoma medication. Results: At the end of 12 months follow-up, the postoperative mean intraocular pressure in the Ologen group was 12.8 ± 1.6 mmHg and 13.4 ± 2.2 mmHg in the Mitomycin C group. The Ologen group achieved complete success in 86.5% and qualified success in 13.5% of the patients, while the Mitomycin C group achieved complete and qualified success in 85.5% and 14.5%, respectively. There was no statistically significant difference in the success rate of both the groups ( p = 0.57). Furthermore, no significant intraocular pressure difference was noted between the two groups at the end of 12 months follow-up ( p = 0.14). Conclusion: Trabeculectomy augmented with Ologen appeared to be as successful and safe as trabeculectomy augmented with Mitomycin C, with no reported adverse reaction to Ologen.

Intraperitoneal Tension-free Repair of a Small Midline Ventral Abdominal Wall Hernia: Randomized Study with a Mean Follow-up of 3 Years

2014 ◽  
Vol 80 (1) ◽  
pp. 57-65 ◽  
Author(s):  
Hocine Bensaadi ◽  
Luca Paolino ◽  
Antonio Valenti ◽  
Claude Polliand ◽  
Christophe Barrat ◽  
...  
Keyword(s):  
Hernia Repair ◽  
Abdominal Wall ◽  
Randomized Study ◽  
Abdominal Wall Hernia ◽  
Late Complications ◽  
Abdominal Wall Defects ◽  
Complication Rates ◽  
Surgeon Experience

Funding received from Cousin Biotech, Wervicq Sud, France, and CR Bard Inc., Cranston, RI. The aim of this prospective randomized study was to determine the long-term recurrence and complication rates after small abdominal wall hernia repair with two different bilayer prostheses. Hernia repair using prosthetic mesh material has become the preferred method of repair, because the recurrence rates are much lower than with conventional repair techniques. The use of a hernia bilayer patch, composite expanded polytetrafluoroethylene (ePTFE)-polypropylene, with intraperitoneal placement behind the hernia defect, through a small incision, may be efficient, safe, and cost-effective. This study is a randomized, single-institution trial, including 83 selected consecutive patients with primary (umbilical, epigastric) or incisional anterior abdominal wall defects from 2 to 5 cm. Hernia repair was performed by direct local access in ambulatory surgery; the prosthesis used was a circular bilayer with an inner face in ePTFE to avoid bowel adhesion. One group was treated with a Ventralex® Hernia Patch (Bard USA). The second group was treated with a Cabs'Air® Composite (Cousin Biotech France), which was delivered with two to four fixation sutures and a balloon to properly deploy the mesh intraperitoneally. Patients’ characteristics and operative and postoperative data were prospectively collected. The primary outcome was late recurrence. Secondary outcomes included, pain, discomfort and quality of life before and after (3 months) surgery using the SF-12 questionnaire, patient-surgeon satisfaction, and early and late complications. Among 98 patients, 83 were included in the study protocol between January 2007 and August 2011. The two groups were comparable according to pre- and intraoperative data. According to surgeon experience, placement of the Cabs'Air® device was significantly faster ( P = 0.01) and easier. At 3 months, there was significantly less pain and less discomfort for the Cabs'Air® group and patient satisfaction rate was higher. This was confirmed by all components of the SF-12 questionnaire. Long-term follow-up was available for 77 patients. The mean follow-up was similar for the two groups (42 months; range, 14 to 70 months). At this point, for the Ventralex® group, there were four recurrences (11.7%); one mesh infection; one small bowel obstruction; and six cases (15.7%) of severe pain resulting from a mass syndrome (shrinkage) with a sense of the presence of a foreign body. Six reoperations (15.6%) were required with explant of the prosthesis. There were no recurrences or late complications in the comparative group. The Ventralex® Hernia Patch is associated with inconsistent deployment, spreading, or shrinkage, which account for late complications and decreases the overlap, which contributes to the recurrence rate. The Cabs'Air®-associated balloon facilitates superior deployment of the prosthesis allowing for good fixation with four sutures.

Cost-effectiveness and long-term effectiveness of Internet-based cognitive behaviour therapy for severe health anxiety

2012 ◽  
Vol 43 (2) ◽  
pp. 363-374 ◽  
Author(s):  
E. Hedman ◽  
E. Andersson ◽  
N. Lindefors ◽  
G. Andersson ◽  
C. Rück ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Health Anxiety ◽  
Primary Outcome Measure ◽  
Behaviour Therapy ◽  
Cognitive Behaviour ◽  
The Cost

BackgroundSevere health anxiety is a common condition associated with functional disability, making it a costly disorder from a societal perspective. Internet-based cognitive behaviour therapy (ICBT) is a promising treatment but no previous study has assessed the cost-effectiveness or long-term outcome of ICBT for severe health anxiety. The aim of this study was to investigate the cost-effectiveness and 1-year treatment effects of ICBT for severe health anxiety.MethodCost-effectiveness and 1-year follow-up data were obtained from a randomized controlled trial (RCT) comparing ICBT (n = 40) to an attention control condition (CC,n = 41). The primary outcome measure was the Health Anxiety Inventory (HAI). A societal perspective was taken and incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap sampling.ResultsThe main ICER was −£1244, indicating the societal economic gain for each additional case of remission when administering ICBT. Baseline to 1-year follow-up effect sizes on the primary outcome measure were large (d = 1.71–1.95).ConclusionsICBT is a cost-effective treatment for severe health anxiety that can produce substantial and enduring effects.

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