Steven J. Gedde

Treatment Outcomes in the Tube Versus Trabeculectomy Study After One Year of Follow-up

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. INTERVENTIONS 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.

Postoperative Complications in the Tube Versus Trabeculectomy (TVT) Study During Five Years of Follow-up

PURPOSE To describe postoperative complications encountered in the Tube Versus Trabeculectomy (TVT) Study during 5 years of follow-up. 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. INTERVENTIONS Tube shunt (350-mm(2) Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC 0.4 mg/mL for 4 minutes). MAIN OUTCOME MEASURES Surgical complications, reoperations for complications, visual acuity, and cataract progression. RESULTS Early postoperative complications occurred in 22 patients (21%) in the tube group and 39 patients (37%) in the trabeculectomy group (P = .012). Late postoperative complications developed in 36 patients (34%) in the tube group and 38 patients (36%) in the trabeculectomy group during 5 years of follow-up (P = .81). The rate of reoperation for complications was 22% in the tube group and 18% in the trabeculectomy group (P = .29). Cataract extraction was performed in 13 phakic eyes (54%) in the tube group and 9 phakic eyes (43%) in the trabeculectomy group (P = .43). CONCLUSIONS A large number of surgical complications were observed in the TVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than tube shunt surgery. The rates of late postoperative complications, reoperation for complications, and cataract extraction were similar with both surgical procedures after 5 years of follow-up.

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

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) > or =18 mm Hg and < or =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 < or =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 > or =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 incidence of postoperative complications was higher following trabeculectomy with MMC relative to tube shunt surgery, most complications were transient and self-limited.

Glaucoma drainage implants: a critical comparison of types

Purpose of review The purpose of this review is to critically compare the various glaucoma drainage implants in popular use. Recent findings Glaucoma drainage implants are being increasingly utilized in the surgical management of glaucoma. Comparisons between the various drainage implants are difficult because most clinical data are derived from retrospective studies with different study populations, follow-up periods, and criteria defining success. The type of glaucoma under treatment is a major factor influencing surgical outcomes. The resistance to aqueous flow through glaucoma drainage implants occurs across the fibrous capsule around the end plate, and the major determinants of the final intraocular pressure are capsular thickness and filtration surface area. The use of antifibrotic agents as adjuncts to drainage implant surgery has not proven effective in modulating capsular thickness. Valved implants appear to reduce, but do not eliminate, the risk of hypotony. Bleb encapsulation is more frequently seen with the Ahmed valve implant than other drainage implants. Diplopia was a common complication with the Baerveldt glaucoma implant after its introduction, but design modifications have markedly reduced the incidence of this complication. Summary There are several glaucoma drainage implants that are currently available, and all have been shown to be safe and effective in reducing intraocular pressure. Greater pressure reduction may be achieved with implants with larger end plates, and valved implants appear to reduce the risk of postoperative hypotony.

Primary Open-Angle Glaucoma Preferred Practice Pattern® Guidelines

UNLABELLED PRIMARY OPEN-ANGLE GLAUCOMA PREFERRED PRACTICE PATTERN® GUIDELINES Evidence-based update of the Primary Open-Angle Glaucoma Preferred Practice Pattern® (PPP) guidelines, describing the diagnosis and management of patients with primary open-angle glaucoma with an algorithm for patient management and detailed recommendations for evaluation and treatment options.

Practice preferences for glaucoma surgery: a survey of the american glaucoma society in 2008.

BACKGROUND AND OBJECTIVE To evaluate glaucoma surgical practice patterns among members of the American Glaucoma Society (AGS). PATIENTS AND METHODS An anonymous web-based survey was sent to AGS members to determine their preferred surgical approach in ten clinical settings. Survey results were compared with those from 1996 and 2002. RESULTS A total of 125 (22%) AGS members responded to the survey. Mean glaucoma drainage device (GDD) usage increased from 17.5% (range: 5% to 37%; standard deviation [SD]: 10.9%) in 1996 to 50.8% (range: 15% to 76%; SD: 17.3%) in 2008, and mean trabeculectomy usage decreased from 80.8% (range: 62% to 93%; SD: 11.3%) in 1996 to 45.5% (range: 16% to 80%; SD: 17.9) in 2008. GDD was most popular in none of 8 clinical settings in 1996, and 5 of 8 clinical settings in 2008. Mitomycin C was selected as an adjunctive antifibrotic agent to trabeculectomy in 85% to 99% of cases. CONCLUSION Glaucoma surgical practice patterns have changed since 1996. The use of a GDD has progressively increased, and the popularity of trabeculectomy decreased between 1996 and 2008. Mitomycin C remains the most frequently selected antifibrotic agent used as an adjunct to trabeculectomy.From Boston Medical Center (MAD), Boston University School of Medicine, Boston, Massachusetts; Bascom Palmer Eye Institute (SJG, WJF, WS, RKP), University of Miami, Miller School of Medicine, Miami, Florida; and the Department of Ophthalmology (PPC), University of Washington, Seattle, Washington.The authors have no financial or proprietary interest in the materials presented herein.Address correspondence to Steven J. Gedde, MD, Bascom Palmer Eye Institute, 900 NW 17th Street, Miami, FL 33136. E-mail: sgedde@med.miami.edu Received: January 19, 2011 Accepted: March 09, 2011.

Management of glaucoma after retinal detachment surgery.

Secondary glaucoma may complicate retinal detachment surgery. Intraocular pressure (IOP) elevation has been described after scleral buckling procedures and vitrectomy with intravitreal injection of gas or silicone oil. Angle-closure glaucoma after scleral buckling develops because of congestion and anterior rotation of the ciliary body. Medical therapy and laser iridoplasty are usually successful in controlling IOP, but the presence of conjunctival scarring and recession and retinal hardware after scleral buckling procedures can make surgical management challenging. Intravitreal injection of expansile gases like sulfur hexafluoride (SF6) and perfluoropropene (C3F8) may produce secondary angle-closure glaucoma with or without pupillary block. Aspiration of a portion of the intraocular gas may be needed, especially if IOP is elevated to a level that may compromise ocular perfusion. Glaucoma also can develop after intravitreal injection of silicone oil secondary to pupillary block, inflammation, synechial angle closure, rubeosis iridis, or migration of emulsified or nonemulsified silicone oil into the anterior chamber. A prophylactic inferior iridectomy at the time of surgery serves to prevent pupillary block. Patients with medically uncontrolled glaucoma after silicone oil injection may require oil removal with or without concurrent glaucoma surgery.

The Tube Versus Trabeculectomy Study: Interpretation of results and application to clinical practice

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 C (MMC) in eyes with previous cataract and/or failed glaucoma surgery. This article interprets results from the TVT Study and applies them to clinical practice. Recent findings Both tube-shunt surgery and trabeculectomy with MMC produced intraocular pressure (IOP) reduction to the low teens throughout the 5-year duration of the study. Tube-shunt surgery was associated with use of more glaucoma medications than trabeculectomy with MMC during the first 2 years of the study, but medical therapy equalized with longer follow-up. Trabeculectomy with MMC had higher rates of surgical failure and reoperation for glaucoma compared with tube-shunt surgery. Vision loss occurred at a similar rate with the two surgical procedures. Early complications were more frequent after trabeculectomy with MMC relative to tube-shunt surgery, but both procedures had similar rates of late postoperative complications and serious complications. Summary Tube-shunt surgery and trabeculectomy with MMC are both viable surgical options for managing glaucoma in patients who have undergone prior cataract and/or failed filtering surgery. Results of the TVT Study support the expanding use of tube shunts beyond refractory glaucomas.

The ahmed baerveldt comparison study: Methodology, baseline patient characteristics, and intraoperative complications

PURPOSE The Ahmed Baerveldt Comparison (ABC) Study compares the long-term outcomes and complications of the Ahmed glaucoma valve (AGV; model FP7; New World Medical, Los Ranchos, CA) and the Baerveldt glaucoma implant (BGI; model 101-350; Abbott Medical Optics, Abbott Park, IL). DESIGN Multicenter, randomized, controlled clinical trial. PARTICIPANTS Two hundred seventy-six glaucoma patients at 16 clinical centers worldwide who were 18 to 85 years of age with inadequately controlled intraocular pressure (IOP; ≥18 mmHg) in whom placement of an aqueous shunt was planned. METHODS Study patients were randomized to undergo implantation of an AGV or a BGI. MAIN OUTCOME MEASURES Failure, defined as IOP >21 mmHg or not reduced by 20% less than baseline or IOP ≤5 mmHg (2 consecutive visits after 3 months), additional glaucoma surgery, removal of the implant, or loss of light perception vision. RESULTS A total of 276 patients were enrolled between October 2006 and April 2008, including 143 in the AGV group and 133 in the BGI group. The mean age±standard deviation (SD) of patients enrolled was 63±14 years, and 52% were male. The mean baseline IOP±SD was 31.5±11.8 mmHg. Except for a 13% higher prevalence of hypertension in the AGV group, no significant differences in baseline demographic or ocular characteristics were observed between the study groups. Intraoperative complications occurred in 11 (8%) patients in the AGV group and in 16 (12%) patients in the BGI group (P = 0.31). CONCLUSIONS The ABC Study should yield valuable prospective data comparing 2 commonly used aqueous shunts in clinical practice.

Delayed-onset bleb-associated endophthalmitis (1996-2008): Causative organisms and visual acuity outcomes

Purpose: The purpose of this study was to report the clinical features, organisms, and outcomes of patients with delayed-onset bleb-associated endophthalmitis. Methods: Retrospective consecutive case series. Patients who were treated for delayed-onset bleb-associated endophthalmitis between January 1, 1996, and July 1, 2008, at a single institution were included. Information on visual acuities, clinical characteristics, causative organisms, and treatment outcomes were collected. Infections within 1 month of glaucoma filtering surgery, inadvertent filtering blebs after cataract surgery, and patients with glaucoma drainage devices were excluded. Results: A total of 71 eyes from 68 patients were identified. An adjunctive antifibrotic agent was used in 48 eyes (68%). The mean time between surgery and endophthalmitis was 4.8 years (range, 0.1-16; standard deviation, 3.6). The average follow-up time after initial treatment was 37 months (range 1-144; standard deviation, 41). At presentation, 17 eyes (24%) had a bleb leak. Fifty-seven eyes (83%) were culture positive. The most common causative organisms were Streptococcus species in 20 eyes (30%), gram-negative organisms in 19 eyes (28%), and coagulase-negative Staphylococcus in 12 eyes (18%). All gram-positive isolates were sensitive to vancomycin. Nine eyes (13%) eventually underwent evisceration or enucleation secondary to pain and/or poor vision. The main outcome measure was best-corrected visual acuity at the last follow-up examination. Final visual acuities in the initial tap/inject group (n = 45) versus the initial vitrectomy group (n = 24) were as follows: ≥20/40 (29% vs. 4.2%), 20/50 to 20/400 (36% vs. 29%), and <5/200 (36% vs. 62%). Conclusion: Streptococcus species and gram-negative organisms were the most common causative isolates identified in this case series of delayed-onset bleb-associated endophthalmitis. Despite treatment of the infection, visual outcomes were generally poor.