Three-Year Follow-up of the Tube Versus Trabeculectomy Study (original) (raw)
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Treatment Outcomes in the Tube Versus Trabeculectomy (TVT) Study After Five Years of Follow-up
American Journal of Ophthalmology, 2012
PURPOSE: To report 5-year treatment outcomes in the Tube Versus Trabeculectomy (TVT) Study. • DESIGN: Multicenter randomized clinical trial. • METHODS: SETTINGS: Seventeen clinical centers. STUDY POPULATION: Patients 18 to 85 years of age who had previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure (IOP) >18 mm Hg and <40 mm Hg on maximum tolerated medical therapy. INTER-VENTIONS: Tube shunt (350-mm 2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C ([MMC]; 0.4 mg/mL for 4 minutes). MAIN OUTCOME MEASURES: IOP, visual acuity, use of supplemental medical therapy, and failure (IOP >21 mm Hg or not reduced by 20%, IOP <5 mm Hg, reoperation for glaucoma, or loss of light perception vision). • RESULTS: A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At 5 years, IOP (mean ؎ SD) was 14.4 ؎ 6.9 mm Hg in the tube group and 12.6 ؎ 5.9 mm Hg in the trabeculectomy group (P ؍ .12). The number of glaucoma medications (mean ؎ SD) was 1.4 ؎ 1.3 in the tube group and 1.2 ؎ 1.5 in the trabeculectomy group (P ؍ .23). The cumulative probability of failure during 5 years of follow-up was 29.8% in the tube group and 46.9% in the trabeculectomy group (P ؍ .002; hazard ratio ؍ 2.15; 95% confidence interval ؍ 1.30 to 3.56). The rate of reoperation for glaucoma was 9% in the tube group and 29% in the trabeculectomy group (P ؍ .025). • CONCLUSIONS: Tube shunt surgery had a higher success rate compared to trabeculectomy with MMC during 5 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 5 years. Additional glaucoma surgery was needed more frequently after trabeculectomy with MMC than tube shunt placement. (Am J Ophthalmol 2012;153:789 -803.
Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up
Ophthalmology, 2018
To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. Multicenter, randomized clinical trial. Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group. Patients were enrolled at 16 clinical centers and assigned randomly to treatment with a tube shunt (350-mmBaerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes). Intraocular pressure (IOP), glaucoma medical therapy, visual acuity, visual fields, surgical complications, and failure (IOP of 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). The cumulative probability of failure during the first year of follow-up was 17.3% in the tube group and 7.9% in the trabeculectomy group (P = 0.01; hazard ratio, 2.59; 95% confidence interval, 1.2...
Review of results from the Tube Versus Trabeculectomy Study
Current Opinion in Ophthalmology, 2010
Purpose of review-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 unsuccessful glaucoma surgery. This article reviews published results from the TVT Study. Recent findings-Tube 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 to 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. Summary-Intermediate-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.
Results of Trabectome Surgery Following Failed Glaucoma Tube Shunt Implantation
Medicine, 2015
Purpose: To evaluate the safety and efficacy of Trabectome after failed tube shunt surgery. Methods: 24 patients with prior failed tube shunt surgery who underwent Trabectome alone or Trabectome combined with phacoemulsification procedures were included. All patients had at least 3 months of follow-up. Outcomes measured included IOP, glaucoma medications and secondary glaucoma surgeries. The success for Kaplan Meier survival analysis is defined as IOP<21mmHg, IOP reduced by at least 20% from pre-operative IOP, and no secondary glaucoma surgery. Results: Mean pre-operative IOP was 23.0±6.5mmHg and mean number of glaucoma medications was 3.2±1.4mmHg. At 12 months, IOP was reduced to 16.1±4.9mmHg (p=0.02) and number of medications was reduced to 2.4±1.5 (p=0.34). Survival rate at 12 months was 83% and 3 patients required additional glaucoma surgery with 15 patients reaching 12 months follow up. Other than failure of IOP control and transient hypotony (IOP<3mm) day 1 in two cases, there were no adverse events. Discussion: Trabecular bypass procedures have traditionally been considered an approach appropriate for early to moderate glaucoma, however, our study indicates benefit in refractory glaucoma as well. Eyes that are prone to conjunctival scarring and hypertrophic wound healing, such as those who have failed tube shunt surgery, may benefit from procedures that avoid conjunctival incision such as Trabectome. This study indicates potential benefits in this patient population. Conclusion: Trabectome was safe and effective in reducing IOP at one year follow-up in patients with prior failed tube shunt surgery, but not effective in reducing medication ABSTRACT Purpose To evaluate the safety and efficacy of Trabectome after failed tube shunt surgery. Methods 20 patients with prior failed tube shunt surgery who underwent Trabectome alone were included. All patients had at least 3 months of follow-up. Outcomes measured included intraocular pressure (IOP), glaucoma medications and secondary glaucoma surgeries. The success for Kaplan Meier survival analysis is defined as IOP<21mmHg, IOP reduced by at least 20% from pre-operative IOP, and no secondary glaucoma surgery. Results Mean pre-operative IOP was 23.7±6.4mmHg and mean number of glaucoma medications was 3.2±1.5. At 12 months, IOP was reduced to 15.5±3.2mmHg (p=0.05) and number of medications was reduced to 2.4±1.5 (p=0.44). Survival rate at 12 months was 84% and 3 patients required additional glaucoma surgery with 15 patients reaching 12 months follow up. Other than failure of IOP control and transient hypotony (IOP<3mmHg) day 1 in two cases, there were no adverse events. Discussion Trabecular bypass procedures have traditionally been considered an approach appropriate for early to moderate glaucoma, however, our study indicates benefit in refractory glaucoma as well. Eyes that are prone to conjunctival scarring and hypertrophic wound healing, such as those who have failed tube shunt surgery, may benefit from procedures that avoid conjunctival incision such as Trabectome. This study indicates potential benefits in this patient population. Conclusion Trabectome was safe and effective in reducing IOP at one year follow-up in patients with prior failed tube shunt surgery, but not effective in reducing medication reliance in these patients.
Long-term Outcomes of Repeat vs Initial Trabeculectomy in Open-Angle Glaucoma
American Journal of Ophthalmology, 2009
To evaluate the long-term intraocular pressure (IOP) control and to identify risk factors for failure of repeat trabeculectomy with mitomycin C (MMC) in patients with open-angle glaucoma. • DESIGN: Retrospective case-control study. • METHODS: Seventy-five eyes (67 patients) that had undergone repeat trabeculectomy with MMC were matched to 75 eyes (64 patients) that had undergone initial trabeculectomy with MMC according to age, gender, race, diagnosis, preoperative IOP, number of glaucoma medications, and lens status in an institutional setting. Surgical successes were defined as: 1) IOP <18 mm Hg and > 20% reduction in IOP, 2) < 15 mm Hg IOP and > 25% reduction in IOP, and 3) < 12 mm Hg IOP and > 30% reduction in IOP from baseline, with or without glaucoma medications, and were assessed by Kaplan-Meier survival analyses. Risk factors for failure in the repeat trabeculectomy group were analyzed by the Cox proportional hazard regression model. The main outcome measures were success rate, number of medications, and visual acuity. • RESULTS: Eyes that underwent initial trabeculectomy with MMC had a statistically significantly higher cumulative surgical success rate than those that underwent repeat trabeculectomy with MMC at 3 years according to criteria B (61.3% vs 41.3%; P ؍ .022) and C (52.0% vs 32.0%; P ؍ .021). In eyes that underwent repeat trabeculectomy, younger age and requirement of laser suture lysis were significant risk factors for surgical failure. Eyes that underwent initial trabeculectomy required a statistically fewer number of medications than eyes that underwent repeat trabeculectomy (0.6 vs 1.2; P ؍ .013). • CONCLUSIONS: Repeat trabeculectomy with MMC is less successful at achieving IOP reduction in open-angle glaucoma than is initial trabeculectomy with MMC at 3 years or more.
Success and complication rates of trabeculectomies augmented with MMC in the management of glaucoma
2010
Glaucoma unresponsive to medical treatment is managed by surgery. Augmentation with mitomycin C (MMC) is considered in patients at high risk of surgery failure. Aim: In this paper we assess and compare the success and complications of this procedure performed in the local state hospital with those of larger international centres. Methods: A retrospective study, of the surgery performed between 2003 and 2007 at St. Luke’s Hospital by one surgeon (FM), was conducted. The total number of eyes considered in this analysis was 32. Intraocular pressures and complications up to one year post-operatively were recorded. Results: The mean intraocular pressure decreased from 30mmHg pre-operatively to 18mmHg post-operatively. The mean IOP drop registered was 42%. Of the 32 eyes that underwent trabeculectomy augmented with MMC, 23 were classified as a complete success with IOP remaining below 21mmHg at 1year post-surgery. Six eyes were considered as a partial success since they had an IOP under 2...
Graefes Archive for Clinical and Experimental Ophthalmology, 2015
Objective To evaluate safety and efficacy of 0.1 mg/ml versus 0.2 mg/ml mitomycin-C (MMC), applied for 1 min subconjunctivally, during trabeculectomy for primary adult glaucoma in previously un-operated eyes. Materials and methods This is a randomised controlled, noninferior, clinical trial consisting of 50 consecutive POAG or CPACG patients uncontrolled on maximal hypotensive therapy, meeting all inclusion criteria. Patients were randomized into two groups and underwent a standard limbus-based trabeculectomy with MMC: Group I, 0.1 mg/ml and Group II, 0.2 mg/ml. The pre-operative and post-operative intraocular pressure (IOP), bleb morphology, and visual acuity were recorded every 6 months for 2 years. Complete success (primary outcome) was defined as IOP≤15 mmHg without any additional medications at the end of 2 years. Results The average age of patients was 62.6±9.8 years and 61.2±8.1 years in Group 1 and 2, respectively; p=0.57. The mean preoperative IOP was 22.5±1.4 mmHg and 23.3± 1.8 mmHg; p=0.10. The mean IOP at 2 years was 11.1± 1.6 mmHg and 10.8±2.8 mmHg, a mean reduction in IOP of 50.6±1.23 %, and 53.7±2.25 % in Group I and II, respectively. The complete success was 92.0 % and 91.7 % in the two groups, respectively (p=0.99), and there was one failure (Group II, post trauma). A wider bleb extent and larger areas of thin, transparent conjunctiva over the bleb were seen with the 0.2 mg/ml MMC group (p<0.001) and in PACG eyes; p<0.04. Conclusion A 1-min subconjunctival application of low dose 0.1 mg/ml MMC is non-inferior to 0.2 mg/ml and is probably a safer alternative, as thinning of the bleb is significantly less frequent in the long term.
Surgical Complications in the Tube Versus Trabeculectomy Study During the First Year of Follow-up
American Journal of Ophthalmology, 2007
AND THE TUBE VERSUS TRABECULECTOMY STUDY GROUP • PURPOSE: To describe the intraoperative and postoperative complications encountered during the first year of follow-up in the Tube Versus Trabeculectomy (TVT) Study. • DESIGN: Multicenter randomized clinical trial. • METHODS: SETTING: Seventeen clinical centers. STUDY POPULATION: Two hundred twelve patients aged 18 to 85 years who had undergone previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure >18 mm Hg and <40 mm Hg on maximum tolerated medical therapy. INTERVENTIONS: A 350-mm 2 Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). MAIN OUTCOME MEASURES: Surgical complications, reoperation for complications, visual acuity, and cataract progression. • RESULTS: Intraoperative complications occurred in seven patients (7%) in the tube group and 10 patients (10%) in the trabeculectomy group (P ؍ .59). Postoperative complications developed in 36 patients (34%) in the tube group and 60 patients (57%) in the trabeculectomy group during the first year of follow-up (P ؍ .001). Surgical complications were associated with reoperation and/or loss of >2 lines of Snellen visual acuity in 18 patients (17%) in the tube group and 28 patients (27%) in the trabeculectomy group (P ؍ .12). • CONCLUSIONS: There were a large number of surgical complications during the first year of follow-up in the study, but most were self-limited. The incidence of postoperative complications was higher after trabeculec-tomy with MMC than nonvalved tube shunt surgery. Serious complications resulting in reoperation and/or vision loss occurred with similar frequency with both surgical procedures. (Am J Ophthalmol 2007;143: 23-31. © 2007 by Elsevier Inc. All rights reserved.)