The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C.
Ontology highlight
ABSTRACT: Purpose
To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study.Design
Multicenter randomized clinical trial.Participants
Patients with medically uncontrolled glaucoma and no prior incisional ocular surgery.Methods
Patients 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 measures
The 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.Conclusions
Practice 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.
SUBMITTER: Gedde SJ
PROVIDER: S-EPMC9289720 | biostudies-literature | 2018 May
REPOSITORIES: biostudies-literature
Publications
The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C.
Gedde Steven J SJ Chen Philip P PP Heuer Dale K DK Singh Kuldev K Wright Martha M MM Feuer William J WJ Schiffman Joyce C JC Shi Wei W
Ophthalmology 20171218 5
<h4>Purpose</h4>To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study.<h4>Design</h4>Multicenter randomized clinical trial.<h4>Participants</h4>Patients with medically uncontrolled glaucoma and no prior incisional ocular surgery.<h4>Methods</h4>Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm<sup>2</sup> Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes).<h4>Main outc ...[more]
Similar Datasets
Project description:IntroductionTo investigate the outcomes of trabeculectomy (TRAB) versus repeat Ahmed glaucoma valve (re-AGV) implantation in eyes with Ahmed glaucoma valve (AGV) failure.MethodsThis quasi-experimental study includes patients with failed AGV implants requiring additional surgical intervention between 2018 and 2022. Patients in the TRAB group underwent a fornix-based procedure with mitomycin C 0.01% injection (0.1 mL). Eyes in the re-AGV group underwent repeat shunt surgery. The choice of the procedure was based on conjunctival condition. The primary outcome measure was surgical success rate based on various intraocular pressure (IOP) targets and percentages of IOP reduction from baseline: IOP ≤ 21 mmHg and 20% reduction (conventional criteria), IOP ≤ 18 and > 20% reduction (criterion A), IOP ≤ 15 and > 25% reduction (criterion B), and IOP ≤ 12 and > 30% reduction (criterion C).ResultsForty-eight eyes of 48 patients were operated and reported herein, consisting of 22 eyes of 22 patients undergoing TRAB and 26 eyes of 26 subjects undergoing re-AGV. No significant difference was observed between the study groups in terms of initial diagnoses, baseline IOP or the number of prior surgeries. The cumulative probability of survival at one year was significantly higher in the trabeculectomy group using the three stricter success definitions. In both study groups, IOP was significantly reduced from baseline at all postoperative visits, and was significantly lower in the TRAB group at all time points beyond one month. At 12 months, 5% of TRAB versus 48% of re-AGV eyes required glaucoma medications (P < 0.001). The rate of complications was comparable between the study groups (P = 0.76) but there was a trend toward a greater need for repeat surgery in the re-AGV group (4 eyes versus nil, P = 0.07).ConclusionsTrabeculectomy can be considered a safe and effective surgical option in eyes with failed AGV leading to significantly lower IOP levels and more favorable success rates than re-AGV in selected patients.
| S-EPMC11342670 | biostudies-literature
Project description:ObjectiveTo determine the effectiveness of trabeculectomy and glaucoma drainage device (GDD) surgery performed with concurrent phacoemulsification compared with stand-alone procedures.DesignMulticenter retrospective cohort study.ParticipantsPatients in the Intelligent Research in Sight Registry who underwent trabeculectomy or GDD from 2013 through 2019.MethodsThe Kaplan-Meier survival analysis was used to determine reoperation rates. Reoperation was defined as any subsequent glaucoma surgery occurring 1 month to 3 years after the initial procedure. Multivariable Cox proportional hazard models were used to determine reoperation risk factors.Main outcome measuresReoperation rate, intraocular pressure (IOP), visual acuity, reoperation procedure type, postoperative complications, and predictors of surgical failure.ResultsA total of 117 697 eyes undergoing glaucoma surgery alone and 35 657 eyes undergoing surgery with phacoemulsification were included. The cumulative reoperation rates at postoperative years 1 and 3 were 4.9% and 11.5%, respectively, for trabeculectomy alone and 3.0% and 7.3%, respectively, for trabeculectomy combined with phacoemulsification (P < 0.001). The reoperation rates at postoperative 1 and 3 years were 3.8% and 7.8%, respectively, for GDD alone and 2.1% and 5.4%, respectively, for GDD with phacoemulsification (P < 0.001). Stand-alone procedures achieved greater IOP reduction by percentage change from baseline (trabeculectomy alone, 35.3% vs. trabeculectomy with phacoemulsification, 23.1%, P < 0.001; and GDD alone, 36.0% vs. GDD with phacoemulsification, 29.3%; P < 0.001). Visual acuity improved by 0.12 logarithm of the minimum angle of resolution (logMAR) (95% confidence interval [CI], 0.11-0.12) and 0.10 logMAR (95% CI, 0.08-0.11) after trabeculectomy and GDD with phacoemulsification and declined by 0.15 logMAR (95% CI, 0.14-0.15) and 0.12 logMAR (95% CI, 0.11-0.12) after stand-alone trabeculectomy and GDD. The overall documented complication rate was 2.9% for GDD and 1.4% for trabeculectomy. Age, sex, race, ethnicity, baseline IOP, and glaucoma diagnosis and severity were associated with surgical failure risk. The most common reoperation procedure was GDD.ConclusionsReoperation rates within the first 3 years after trabeculectomy and GDD with and without phacoemulsification were low. Trabeculectomy and GDD with phacoemulsification had lower reoperation rates than those with stand-alone procedures. However, stand-alone procedures resulted in greater IOP reduction compared with combined procedures. Postoperative complications were uncommon overall. Patient age, sex, race, ethnicity, baseline IOP, and glaucoma diagnosis and severity were associated with surgical success.
| S-EPMC9839888 | 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: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:PurposeTo describe postoperative complications encountered in the Primary Tube Versus Trabeculectomy (PTVT) Study during 5 years of follow-up.DesignMulticenter randomized clinical trial.ParticipantsA total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group.MethodsPatients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC, 0.4 mg/ml for 2 minutes).Main outcome measuresSurgical complications, reoperations for complications, visual acuity, and cataract progression.ResultsEarly postoperative complications occurred in 24 patients (19%) in the tube group and 40 patients (34%) in the trabeculectomy group (P = 0.013). Late postoperative complications developed in 27 patients (22%) in the tube group and 32 patients (27%) in the trabeculectomy group (P = 0.37). Serious complications producing vision loss and/or requiring a reoperation were observed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). Cataract progression was seen in 65 patients (52%) in the tube group and 52 patients (44%) in the trabeculectomy group (P = 0.30). Surgical complications were not associated with a higher rate of treatment failure (P = 0.61), vision loss (P = 1.00), or cataract progression (P = 0.77) CONCLUSIONS: A large number of surgical complications were observed in the PTVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than with tube shunt surgery. The rates of late postoperative complications, serious complications, and cataract progression were similar with both surgical procedures after 5 years of follow-up. Surgical complications did not increase the risk of treatment failure, vision loss, or cataract progression.
| S-EPMC9691562 | biostudies-literature
Project description:PurposeTo report 5-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study.DesignMulticenter randomized clinical trial.ParticipantsA total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group.MethodsPatients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 2 minutes).Main outcome measuresThe primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) > 21 mmHg or reduced < 20% from baseline, IOP ≤ 5 mmHg, reoperation for glaucoma, or loss of light perception. Secondary outcome measures included IOP, glaucoma medical therapy, and visual acuity.ResultsThe cumulative probability of failure after 5 years of follow-up was 42% in the tube group and 35% in the trabeculectomy group (P = 0.21; hazard ratio = 1.31; 95% confidence interval = 0.86-2.01). At 5 years, IOP (mean ± standard deviation) was 13.4 ± 3.5 mmHg in the tube group and 13.0 ± 5.2 mmHg in the trabeculectomy group (P = 0.52), and the number of glaucoma medications (mean ± standard deviation) was 2.2 ± 1.3 in the tube group and 1.3 ± 1.4 in the trabeculectomy group (P < 0.001).ConclusionsTrabeculectomy with MMC and tube shunt surgery produced similar IOPs after 5 years of follow-up in the PTVT Study, but fewer glaucoma medications were required after trabeculectomy. No significant difference in the rate of surgical failure was observed between the 2 surgical procedures at 5 years.
| S-EPMC9691551 | 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:PurposeTo describe visual field (VF) outcomes in the Tube Versus Trabeculectomy (TVT) Study.DesignCohort analysis of patients in a multicenter randomized clinical trial.ParticipantsA total of 122 eyes of 122 patients, with 61 eyes in both the tube shunt and trabeculectomy groups.MethodsThe TVT Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery (350-mm2 Baerveldt implant) and trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 4 minutes) in patients with previous cataract or glaucoma surgery. Enrolled patients underwent perimetry at baseline and annual follow-up visits. The VFs were included if the false-positive rate was ≤20% and false-negative rate was ≤35%. The VFs were excluded if visual acuity <20/400 or loss of ≥2 Snellen lines from baseline was attributed to an etiology other than glaucoma. Longitudinal linear mixed-effects models with best linear unbiased predictions (BLUPs) were applied to estimate rates of change in mean deviation (MD) for each treatment group.Main outcome measureRate of MD change during follow-up period.ResultsA total of 436 reliable VFs were analyzed, with an average of 3.6 VFs per eye. Baseline MD was -13.07 ± 8.4 decibels (dB) in the tube shunt group and -13.18 ± 8.2 dB in the trabeculectomy group (P = 0.99). The rate of change in MD was -0.60 dB/year in the tube group and -0.38 dB/year in the trabeculectomy group (P = 0.34). The 95% confidence intervals for the rates of MD change were -0.77 to -0.44 dB/year in the tube group and -0.56 to -0.20 dB/year in the trabeculectomy group. No significant difference in MD slope was seen when patients were categorized by percentage of visits with intraocular pressure (IOP) <18 mmHg or by average IOP. Univariable and multivariable risk factor analyses identified history of diabetes, elevated IOP, and worse MD as baseline factors associated with more rapid VF loss.ConclusionsSlow rates of VF loss were observed after randomized surgical treatment in the TVT Study, but no significant difference in the rate of VF loss was seen after tube shunt implantation and trabeculectomy with MMC. Patients with diabetes, higher IOP, and more severe VF loss at baseline were at higher risk for VF progression.
| S-EPMC9289722 | 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:ObjectiveTo compare the efficacy and safety of tube shunt implantation with trabeculectomy in the treatment of patients with glaucoma.MethodsA systematic literature search was performed for studies comparing tube with trabeculectomy in patients with glaucoma (final search date: 27 February 2022). Comparisons between tube and trabeculectomy were grouped by the type of tube (Ahmed, Baerveldt, Ex-PRESS and XEN). The primary endpoints included intraocular pressure (IOP), IOP reduction (IOPR), IOPR percentage (IOPR%), complete success rate (CSR), qualified success rate (QSR) and adverse events (AEs).ResultsForty-nine studies were included in this meta-analysis and presented data for 3795 eyes (Ahmed: 670, Baerveldt: 561, Ex-PRESS: 473, XEN: 199, trabeculectomy: 1892). Ahmed and Ex-PRESS were similar to trabeculectomy in terms of IOP outcomes and success rate (Ahmed vs trabeculectomy: IOPR%: mean difference (MD)=1.34 (-5.35, 8.02), p=0.69; Ex-PRESS vs trabeculectomy: IOPR%: MD=0.12 (-3.07, 3.31), p=0.94). The IOP outcomes for Baerveldt were worse than those for trabeculectomy (IOPR%: MD=-7.51 (-10.68, -4.35), p<0.00001), but the QSR was higher. No significant difference was shown for the CSR. XEN was worse than trabeculectomy in terms of IOP outcomes (IOPR%: MD=-7.87 (-13.55, -2.18), p=0.007), while the success rate was similar. Ahmed and Ex-PRESS had a lower incidence of AEs than trabeculectomy. Baerveldt had a lower incidence of bleb leakage/wound leakage, hyphaema and hypotonic maculopathy than trabeculectomy but a higher incidence of concurrent cataracts, diplopia/strabismus and tube erosion. The incidence of AEs was similar for the XEN and trabeculectomy procedures.ConclusionCompared with trabeculectomy, both Ahmed and Ex-PRESS appear to be associated with similar ocular hypotensive effects and lower incidences of AEs. However, Baerveldt and XEN cannot achieve sufficient reductions in IOP outcomes similar to those of trabeculectomy.Prospero registration numberCRD42021257852.
| S-EPMC10273552 | biostudies-literature