Intracameral Bevacizumab Versus Sub-Tenon's Mitomycin C as Adjuncts to Trabeculectomy: 3-Year Results of a Prospective Randomized Study.
Ontology highlight
ABSTRACT:
SUBMITTER: Kopsinis G
PROVIDER: S-EPMC8151253 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:PurposeTo evaluate the efficacy of subconjunctival bevacizumab (ScB) as adjuvant therapy to primary trabeculectomy with mitomycin C (MMC) in primary open-angle glaucoma.Materials and methodsForty-six eyes of primary open-angle glaucoma patients were randomized to receive ScB (1.25 mg/0.05 mL) injections (the MMC+ScB group) at the end of the operations, or sham-treated controls (the MMC group). Intraocular pressure (IOP) was the primary outcome and secondary outcomes included bleb appearance, visual acuity, number of medications, complications, and proportion of eyes achieving successful outcomes at the 12-month follow-up.ResultsOf 39 eyes, 20 eyes from the MMC+ScB group, and 19 eyes from the MMC group completed the follow-up. The mean postoperative IOP was 15.5±4.1 mm Hg in the MMC+ScB group (P<0.01; 40% reduction), and 14.7±4.3 mm Hg in the MMC group (P<0.01; 44% reduction). The differences in IOPs, at all follow-up visits, were not significant (P>0.05). The mean bleb vascularity score, at 1 month, in the MMC+ScB group was lower than the MMC group (1.55±0.51 vs. 2.26±0.6, respectively, P=0.01), but was not retained at follow-ups. The success rates at 12 months after surgery were 85% in the MMC+ScB group and 89.5% in the MMC group (P=0.53). The cumulative probabilities of surgical success were 80% and 73.7% in the MMC+ScB and in the MMC group, respectively (P=0.52).ConclusionSingle adjunctive ScB injection did not appear to have an additive benefit on outcomes of MMC trabeculectomy, in terms of IOPs and success rates.
| S-EPMC4614532 | biostudies-literature
Project description:PurposeTo compare the efficacy and safety of the PRESERFLO™ MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG) after one year.Patients and methodsInstitutional prospective interventional cohort study comparing eyes with POAG, which had received the PRESERFLO™ MicroShunt versus trabeculectomy. The MicroShunt group was matched with the trabeculectomy group for age, known duration of disease, and number and classes of intraocular pressure (IOP) lowering medications to have similar conjunctival conditions. The study is part of the Dresden Glaucoma and Treatment Study, using a uniform study design, with the same inclusion and exclusion criteria, follow-ups and standardized definitions of success and failure for both procedures.Primary outcome measuresmean diurnal IOP (mdIOP, mean of 6 measurements), peak IOP, and IOP fluctuations.Secondary outcome measuressuccess rates, number of IOP lowering medications, visual acuity, visual fields, complications, surgical interventions, and adverse events.ResultsSixty eyes of 60 patients, 30 in each group, were analyzed after 1-year follow-ups. Median [Q25, Q75] mdIOP (mmHg) dropped from 16.2 [13.8-21.5] to 10.5 [8.9-13.5] in the MicroShunt and from 17.6 [15.6-24.0] to 11.1 [9.5-12.3] in the trabeculectomy group, both without glaucoma medications. Reduction of mdIOP (P = .596), peak IOP (P = .702), and IOP fluctuations (P = .528) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy group, especially in the early postoperative period (P = .018). None of the patients experienced severe adverse events.ConclusionBoth procedures are equally effective and safe in lowering mdIOP, peak IOP and IOP fluctuations in patients with POAG, one year after surgery.Clinical trial registrationNCT02959242.
| S-EPMC10155172 | biostudies-literature
Project description:ObjectiveTo evaluate the application of the Ologen implant compared to mitomycin C (MMC) on the outcome of trabeculectomy and to examine the balance of risks and benefits.MethodsA systematic literature search (Pubmed, Embase, the Cochrane Library, and the Chinese Biomedicine Database) was performed. Randomized controlled trials comparing the Ologen implant with MMC in trabeculectomy were selected. The efficacy measures were the weighted mean differences (WMDs) for the intraocular pressure reduction (IOPR), the reduction in glaucoma medications, and the relative risks (RRs) for success rates. The tolerability measures were RRs for adverse events. The pooled effects were calculated using the random-effects model.ResultsSeven randomized controlled trials including 227 eyes were included in this meta-analysis. The WMDs of the IOPR comparing the Ologen group with the MMC group were -2.98 (95% Cl: -5.07 to -0.89) at one month, -1.41 (-3.72 to 0.91) at three months, -1.69 (-3.68 to 0.30) at six months, -1.94 (-3.88 to 0.01) at 12 months, and 0.65 (-2.17 to 0.47) at 24 months. There was no statistically significance except at one and 12 months after surgery. No significant difference in the reduction in glaucoma medications or complete and qualified success rates were found. The rates of adverse events also did not differ significantly between Ologen and MMC.ConclusionsThe Ologen implant is comparable with MMC for trabeculectomy in IOP-lowering efficacy, reduction in the number of glaucoma medications, success rates, and tolerability. However, the results should be interpreted cautiously since relevant evidence is still limited, although it is accumulating. Further large-scale, well-designed randomized controlled trials are urgently needed.
| S-EPMC3896400 | biostudies-literature
Project description:ImportanceThere is evidence that patients of African descent (AD) experience higher surgical failure rate after trabeculectomy without antimetabolites.ObjectiveTo compare outcomes of initial trabeculectomy with mitomycin C in AD patients with those of patients of European descent (ED) and to identify prognostic factors for failure.Design, setting, and participantsIn this retrospective matched cohort study, 135 eyes of 105 AD patients were matched with 135 eyes of 117 ED patients by age (within 5 years), surgeon, lens status, and follow-up time (within 1 year) from a single tertiary academic center.InterventionsInitial trabeculectomy with mitomycin C.Main outcomes and measuresCriteria A, B, and C defined qualified success rates as final intraocular pressure of 18 mm Hg or less, 15 mm Hg or less, and 12 mm Hg or less, respectively, in addition to 20% or more, 25% or more, and 30% or more reduction of intraocular pressure or reduction of 2 or more medications. Kaplan-Meier survival curves were compared with log-rank test in AD and ED patients, and Cox proportional hazard models were used to estimate the influence of race/ethnicity on surgical success accounting for confounding variables.ResultsOf the 105 AD patients, 56 (53.3%) were female, and the mean (SD) age was 67.5 (10.4) years; of the 117 ED patients, 64 (54.7%) were female, and the mean (SD) age was 68.2 (10.0) years. For AD patients compared with ED patients, the qualified success rates at 5 years for criteria A were 61% and 67%, respectively (difference, 7.3%; 95% CI, 4.4-10.4); for criteria B, 43% and 60% (difference, 17.6%; 95% CI, 15.2-20.0); and for criteria C, 25% and 40% (difference, 15.8%; 95% CI, 11.1-20.5). On multivariable Cox regression analyses, AD was associated with higher failure rate with criteria B and C for qualified success and with all criteria for complete success (ie, no need for medications). Incidence of bleb leaks was higher in the AD group (29 vs 11 eyes; P = .002). Additionally, AD patients required additional glaucoma surgeries more often than ED patients (47 vs 26 eyes; P = .004).Conclusions and relevanceAfrican descent was associated with higher failure rates and higher incidence of bleb leaks after initial trabeculectomy with mitomycin C compared with European descent. If this is subsequently shown to be a cause and effect, the findings need to be considered when surgical treatment of glaucoma is contemplated in AD patients.
| S-EPMC6583864 | biostudies-literature
Project description:AimTo compare the effectiveness of postoperative adjunctive use of subconjunctival bevacizumab in altering the outcome of primary trabeculectomy in terms of sustained lowering of intraocular pressure (IOP) and reduction of postoperative bleb vascularization and fibrosis.MethodsA prospective, one center, randomized, placebo-control study. Fifty-nine patients (59 eyes) with uncontrolled IOP under maximal tolerated medical treatment (MTMT) were recruited. A primary trabeculectomy with mitomycin C (MMC) was done and the patients were randomized to either postoperative subconjunctival injection of bevacizumab (1.25 mg/0.05 mL) or balanced salt solution (BSS). Forty-seven patients (47 eyes) completed at least one year of follow up and were included in the study. The main outcome measure was the IOP, and secondary outcome measures include bleb morphology, vascularization, and fibrosis, as well as the need for glaucoma medications and 5-fluorouracil (5-FU) needling.ResultsAt 1-year follow up, there was no significant difference between groups for IOP (P=0.65), bleb morphology (P=0.65), and the need for glaucoma medications (P=0.65) or 5-FU needling requirements (P=0.11). However, the bevacizumab group had a higher rate of success results, lower use of glaucoma medications after surgery, and optimal bleb aspect in more patients, but more 5-FU needling procedures required.ConclusionA bigger sample size is needed in order to determine whether the differences found in the bevacizumab group are statistically significant.
| S-EPMC6796091 | biostudies-literature
Project description:The Tube Versus Trabeculectomy (TVT) Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery to trabeculectomy with mitomycin (MMC) in eyes with previous cataract and/or failed glaucoma surgery. Tube shunt surgery was more likely to maintain intraocular pressure (IOP) control and avoid persistent hypotony, reoperation for glaucoma, or loss of light perception vision than trabeculectomy with MMC during the first year of follow-up. Both surgical procedures had similar IOP reduction at 1 year, but less supplemental medical therapy was used following trabeculectomy. The incidence of postoperative complications was higher after trabeculectomy with MMC relative to tube shunt surgery, but serious complications associated with vision loss and/or reoperation developed with similar frequency after both of the procedures. There was no significant difference in the rate of vision loss following trabeculectomy with MMC and tube shunt surgery after 1 year of follow-up. Cataract progression was common, but occurred with similar frequency with both of the surgical procedures.
| S-EPMC2813602 | biostudies-literature
Project description:PURPOSE:To compare trabeculectomy with mitomycin-C (MMC) application before versus after scleral flap dissection in terms of corneal endothelial cell loss and surgical outcomes. METHODS:In this double blind clinical trial, patients were randomized to MMC 0.02% application before (group A) or after (group B) scleral flap dissection. The main outcome measure was corneal endothelial cell density; secondary outcome measures included IOP, glaucoma medications, success rates (IOP ?21 and ?18 mmHg, defined as criterion 1 and 2, respectively) and complications. RESULTS:Overall, 99 eyes of 99 subjects including 72 male and 27 female subjects were operated and followed for at least 6 months. The study groups were comparable in terms of baseline variables. Outcomes of surgery were similar at six months in terms of IOP (11.8±5.8 vs. 11.7±5.5 mmHg, P=0.88) and number of medications (0.2 ±0.6 vs 0.1±0.4, P=0.45). Overall success was comparable at months 1 and 3, but higher in group B at month 6 (82.0% vs. 63.3%, P=0.036 for criterion 1 and 78.9% vs. 59.2%, P=0.044 for criterion 2). Hypotony was more prevalent in group B (8.0% versus 2.0%) but the difference was not significant (P=0.38). Endothelial cell density loss (2.2±7.3 vs 0.9±6.3%, P=0.567) was comparable between the study groups. CONCLUSION:Corneal endothelial loss following trabeculectomy was comparable with MMC application before and after scleral flap dissection. The sequences were comparable in terms of postoperative IOP and glaucoma medications. Overall success rate was higher at six months in group B and the rate of hypotony was also higher, although insignificantly.
| S-EPMC4795388 | biostudies-literature
Project description:PurposeTo describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study.DesignMulticenter randomized clinical trial.ParticipantsPatients with medically uncontrolled glaucoma and no prior incisional ocular surgery.MethodsPatients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes).Main outcome measuresThe primary outcome measure is the rate of surgical failure, defined as intraocular pressure (IOP) more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures include IOP, glaucoma medical therapy, visual acuity, visual fields, and surgical complications.ConclusionsPractice patterns vary in the surgical management of glaucoma, and opinions differ among surgeons regarding the preferred primary operation for glaucoma. The PTVT Study will provide valuable information comparing the 2 most commonly performed glaucoma surgical procedures.
| S-EPMC9289720 | biostudies-literature
Project description:Purpose of reviewThe Tube Versus Trabeculectomy (TVT) Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube-shunt surgery to trabeculectomy with mitomycin (MMC) in eyes with previous cataract and/or unsuccessful glaucoma surgery. This article reviews published results from the TVT Study.Recent findingsTube-shunt surgery had a higher success rate than trabeculectomy with MMC during the first 3 years of follow-up. Trabeculectomy with MMC produced greater intraocular pressure (IOP) reduction in the early postoperative period compared with tube-shunt placement, but similar IOPs were observed after 3 months. Tube-shunt surgery was associated with greater use of adjunctive-medical therapy than trabeculectomy with MMC during the first 2 years of the study, but no difference in medication use was seen at 3 years. The incidence of postoperative complications was higher after trabeculectomy with MMC compared with tube-shunt surgery, but serious complications associated with vision loss and/or reoperation developed with similar frequency after both surgical procedures. No difference in the rate of vision loss was present following trabeculectomy with MMC and tube-shunt surgery after 3 years of follow-up. Cataract progression was common, but occurred with similar frequency with both procedures.SummaryIntermediate-term results of the TVT Study support the expanded use of tube shunts beyond refractory glaucomas. Tube-shunt surgery is an appropriate surgical option in patients who have undergone prior cataract and/or unsuccessful filtering surgery.
| S-EPMC5584063 | biostudies-literature
Project description:Antifibrotic agents are commonly utilized to enhance the success rates of trabeculectomy. Novel approaches to further improve success rates and reduce the risks of complications are needed. The purpose of this study was to compare intraocular pressure (IOP)-lowering efficacy and safety of trabeculectomy or combined phacoemulsification and trabeculectomy with mitomycin-C (MMC) vs. Collagen Matrix (CM).A prospective, multicenter, randomized controlled trial was performed. Ninety-five eyes of 94 patients with uncontrolled glaucoma despite medical therapy, without previous incisional glaucoma surgery underwent trabeculectomy (85 eyes) or combined phacoemulsification and trabeculectomy (10 eyes) and were randomized to MMC or CM. One eye of each subject was analyzed. Patients were followed for 24 months. The criteria for complete success were IOP >5 and ?21 mmHg with at least a 20% reduction below medicated baseline without additional glaucoma surgery or medications. The main outcome measures were complete success rates at 24 months with Kaplan-Meier analysis and incidence of adverse events.The baseline IOPs were 20.4?±?6.0 mmHg and 21.2?±?6.1 (mean?±?standard deviation, p?=?0.49) on 3.2?±?1.1 and 3.1?±?1.0 medications (p?=?0.53) compared to 11.8?±?5.2 and 12.8?±?3.7 (p?=?0.36) on 0.5?±?0.8 and 0.6?±?1.0 medications (p?=?0.63) at 2 years in the MMC and CM groups, respectively. Kaplan-Meier analysis demonstrated complete success rates were similar in both groups at 24 months: 38.4?±?7.6% with MMC and 56.2?±?7.9% with CM (mean?±?standard error, p?=?0.112, log rank test); however, a significantly higher incidence of failure due to persistent hypotony was observed with MMC (p?=?0.002).Use of the CM implant at the time of trabeculectomy or combined phacoemulsification and trabeculectomy is associated with similar complete success rates compared to adjunctive MMC; however, the risk of persistent hypotony is higher with MMC.ClinicalTrials.gov registration number NCT01440751 . Registered 9/14/11.
| S-EPMC5200961 | biostudies-literature