Surgical Complications in the Tube Versus Trabeculectomy Study During the First Year of Follow-up (original) (raw)

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.

Three-Year Follow-up of the Tube Versus Trabeculectomy Study

American Journal of Ophthalmology, 2010

PURPOSE: To report 3-year results of the Tube Versus Trabeculectomy (TVT) Study. • DESIGN: Multicenter randomized clinical trial. • METHODS: SETTING: Seventeen clinical centers. STUDY POPULATION: Patients 18 to 85 years of age who had previous trabeculectomy, cataract extraction with intraocular lens implantation, or both and uncontrolled glaucoma with intraocular pressure (IOP) >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 0.4 mg/ml for 4 minutes). MAIN OUTCOME MEASURES: IOP, visual acuity, use of supplemental medical therapy, surgical complications, 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 3 years, IOP (mean ؎ standard deviation [SD]) was 13.0 ؎ 4.9 mm Hg in the tube group and 13.3 ؎ 6.8 mm Hg in the trabeculectomy group (P ‫؍‬ .78). The number of glaucoma medications (mean ؎ SD) was 1.3 ؎ 1.3 in the tube group and 1.0 ؎ 1.5 in the trabeculectomy group (P ‫؍‬ .30). The cumulative probability of failure during the first 3 years of follow-up was 15.1% in the tube group and 30.7% in the trabeculectomy group (P ‫؍‬ .010; hazards ratio, 2.2; 95% confidence interval, 1.2 to 4.1). Postoperative complications developed in 42 patients (39%) in the tube group and 63 patients (60%) in the trabeculectomy group (P ‫؍‬ .004). Surgical complications were associated with reoperation and/or loss of >2 Snellen lines in 24 patients (22%) in the tube group and 28 patients (27%) in the trabeculectomy group (P ‫؍‬ .58). • CONCLUSIONS: Tube shunt surgery had a higher success rate compared to trabeculectomy with MMC during the first 3 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 3 years. While the inci-dence of postoperative complications was higher following trabeculectomy with MMC relative to tube shunt surgery, most complications were transient and self-limited. (Am J Ophthalmol 2009;xx:xxx.

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.

Postoperative management of trabeculectomy and glaucoma drainage implant surgery

Current Opinion in Ophthalmology, 2016

Purpose of review This article describes important aspects of postoperative management after trabeculectomy and glaucoma drainage implant surgery. Recent findings Postoperative management of glaucoma drainage implant surgery includes stabilization of intraocular pressure, possible ligature release, and management of complications such as corneal edema, and tube/ plate exposure. Postoperative management of trabeculectomy includes evaluation of bleb encapsulation, management of hypotony, and assessment of need for adjuvant therapy. Recent advances in surgical techniques, device/tissue availability, and imaging continue to shape the postoperative course. Summary Careful preoperative planning and postoperative care may decrease the likelihood of complications in tube surgery or trabeculectomy.

Long-Term Follow-Up of Initially Successful Trabeculectomy

Ophthalmology, 1997

The purpose was to study the long-term outcomes of primary trabeculectomies that were successful at 1 year. Design: A retrospective study of patients with various types of glaucoma who had trabeculectomies that were successful at 1 year and who had a follow-up of at least 10 years. Participants: There were 40 patients (40 eyes) who had primary trabeculectomies that were successful at 1 year and who had a follow-up range of 10 to 21 years. Intervention: Control of intraocular pressure (lOP) and disease progression was evaluated at 5, 10, and 15 years and at the last obtainable follow-up. Main Outcome Measures: Successful control of lOP was defined as lOP less than 21 mmHg or a reduction of 33% if preoperative lOP was less than 21 mmHg. Successful control of disease progression was defined as stable cup-disc ratios determined by examination, or color photographs or both, as well as stable visual fields. Results: If an eye was considered successful by lOP at 1 year, the probability of successful control of lOP was 82% at 5 years and 67% at 10 and 15 years. If an eye was considered successful by lOP at 1 year, the probability of successful control of disease progression at 5 years was 77%, at 10 years 61 %, and at 15 years 48%. If an eye did not require further glaucoma surgery at 1 year, the probability that it still would not need further surgery at 5 years was 90%, at 10 years 75%, and at 15 years 67%. Forty percent of eyes had cataract extraction by the time of last follow-up examination. Conclusions: Loss of lOP control and progression of glaucomatous damage occurs over time despite initial success at 1 year.

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.