Estudios primarios incluidos en esta revisión sistemática

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Estudio primario

No clasificado

Comparación de la trabeculectomía y la implantación Ex-PRESS en compañeros de ojos del mismo paciente: un estudio prospectivo, aleatorizado.

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Autores Dahan E , Ben Simon GJ , Lafuma A
Revista Eye (London, England)
Año 2012
Enlaces Pubmed DOI PubMed Central
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OBJETIVO: Comparar la presión intraocular (PIO) con el tiempo después de la trabeculectomía estándar vs implante Ex-PRESS en pacientes con glaucoma primario de ángulo abierto bilateral (GPAA). DISEÑO: Estudio prospectivo, aleatorizado. Pacientes y métodos: Este estudio incluyó a pacientes adultos con GPAA bilateral que requiere cirugía. Cada paciente fue sometido a trabeculectomía en un ojo y la implantación Ex-PRESS bajo un colgajo escleral en el otro ojo de acuerdo con las asignaciones contralateral aleatorios. La eficacia fue evaluada por los valores de la PIO y las tasas de éxito (umbral y / o necesidad de la PIO de medicación tópica glaucoma) durante 30 meses. El análisis estadístico incluyó modelos Generalizadas Estimación de ecuaciones y Cox de supervivencia, y vinculado pruebas t. RESULTADOS: Treinta ojos de 15 pacientes fueron estudiados durante una media de 23,6 meses (DE, ± 6,9). En la última visita de seguimiento, la media preoperatoria PIO disminuyó de 31,1 (± 14,2) a 16,2 (± 1,5) mm Hg después de la trabeculectomía, y de 28,1 (± 9,0) a 15,7 (± 1,8) mm Hg después de Ex-PRESS implantación (P = 0,001). El número medio de medicamentos anti-glaucoma prescritos en el último seguimiento se redujo de 3,7 antes de la cirugía (ambos grupos) a 0,9 después de trabeculectomía vs 0,3 después de la implantación Ex-PRESS (P = 0,001). Tarifas completas de éxito (5 <PIO <18 mm Hg sin medicamentos) fueron mayores con Ex-PRESS en comparación con la trabeculectomía (P = 0,0024). Las complicaciones postoperatorias fueron más frecuentes después de la trabeculectomía (33%) en comparación con el Ex-PRESS (20%), con cuatro ojos trabeculectomía (27%) que necesitan intervenciones postoperatorias, en comparación con ninguno de Ex-PRESS. CONCLUSIONES: Trabeculectomía y Ex-PRESS implantación proporcionado control de la PIO similar, pero el grupo Ex-PRESS tenido una menor tasa de complicaciones, menos intervenciones postoperatorias, y se necesitan menos medicamentos para el glaucoma.

Estudio primario

No clasificado

Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

Revista Clinical ophthalmology (Auckland, N.Z.)
Año 2011
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Background: This study compared the efficacy of the EX-PRESS® glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. Methods: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication. Results: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation. Conclusion: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma. © 2011 de Jong et al, publisher and licensee Dove Medical Press Ltd.

Estudio primario

No clasificado

The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications.

Revista Ophthalmology
Año 2011
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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.

Estudio primario

No clasificado

Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up.

Revista Ophthalmology
Año 2011
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PURPOSE: To determine the relative efficacy and complications of the Ahmed glaucoma valve (AGV) model FP7 (New World Medical, Ranchos Cucamonga, CA) and the Baerveldt glaucoma implant (BGI) model 101-350 (Abbott Medical Optics, Abbott Park, IL) in refractory glaucoma. DESIGN: Multicenter, randomized, controlled clinical trial. PARTICIPANTS: Two hundred seventy-six patients, including 143 in the AGV group and 133 in the BGI group. METHODS: Patients 18 to 85 years of age with refractory glaucoma having intraocular pressure (IOP) of 18 mmHg or more in whom an aqueous shunt was planned were randomized to undergo implantation of either an AGV or a BGI. MAIN OUTCOME MEASURES: The primary outcome was failure, defined as IOP >21 mmHg or not reduced by 20% from baseline, IOP ≤5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision. Secondary outcomes included mean IOP, visual acuity, use of supplemental medical therapy, and complications. RESULTS: Preoperative IOP (mean±standard deviation [SD]) was 31.2±11.2 mmHg in the AGV group and 31.8±12.5 mmHg in the BGI group (P = 0.71). At 1 year, mean±SD IOP was 15.4±5.5 mmHg in the AGV group and 13.2±6.8 mmHg in the BGI group (P = 0.007). The mean±SD number of glaucoma medications was 1.8±1.3 in the AGV group and 1.5±1.4 in the BGI group (P = 0.071). The cumulative probability of failure was 16.4% (standard error [SE], 3.1%) in the AGV group and 14.0% (SE, 3.1%) in the BGI group at 1 year (P = 0.52). More patients experienced early postoperative complications in the BGI group (n = 77; 58%) compared with the AGV group (n = 61; 43%; P = 0.016). Serious postoperative complications associated with reoperation, vision loss of ≥2 Snellen lines, or both occurred in 29 patients (20%) in the AGV group and in 45 patients (34%) in the BGI group (P = 0.014). CONCLUSIONS: Although the average IOP after 1 year was slightly higher in patients who received an AGV, there were fewer early and serious postoperative complications associated with the use of the AGV than the BGI.

Estudio primario

No clasificado

Review of results from the Tube Versus Trabeculectomy Study.

Revista Current opinion in ophthalmology
Año 2010
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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 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. 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.

Estudio primario

No clasificado

Three-year follow-up of the tube versus trabeculectomy study.

Revista American journal of ophthalmology
Año 2009
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PURPOSE: To report 3-year results of the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Multicenter randomized clinical trial. METHODS: None 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.

Estudio primario

No clasificado

The Ex-PRESS glaucoma shunt versus trabeculectomy in open-angle glaucoma: A prospective randomized study

Autores de Jong LA
Revista Advances in therapy
Año 2009
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Introduction: The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma. Methods: This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a scleral flap, or trabeculectomy. The main outcome measures were: mean intraocular pressure (IOP), postoperative medication use, visual acuity, and incidence of complications. Complete success was defined as an IOP of >4 mmHg and ≤18 mmHg without the use of antiglaucoma medications. A more stringent target of IOP >4 mmHg and ≤15 mmHg was also noted. Results: There were 78 patients (80 eyes) with primary open-angle, pseudoexfoliative, or pigmentary glaucoma enrolled in the study. A total of 84.6% of patients receiving Ex-PRESS and 60.0% of patients receiving trabeculectomy (P=0.0230) achieved complete success. The respective proportions of patients achieving an IOP >4 mmHg and ≤15 mmHg were 76.9% and 50.0% (P=0.0193). At 1-year follow-up, complete success rates were 81.8% for Ex-PRESS and 47.5% for trabeculectomy (P=0.0020), and 71.7% and 37.5% (P=0.0070), respectively, for the more stringent target. There was a similar level of postoperative interventions and complications for each group. Conclusions: In open-angle glaucoma, the Ex-PRESS mini glaucoma shunt implanted under a superficial scleral flap produces significantly higher success rates, and a similar complication rate, compared with trabeculectomy. The Ex-PRESS is a safe and effective device for treating open-angle glaucoma. © 2009 Springer Healthcare Communications.

Estudio primario

No clasificado

Motility Disturbances in the Tube Versus Trabeculectomy Study During the First Year of Follow-up

Revista American journal of ophthalmology
Año 2009
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Purpose: To describe the preoperative and postoperative motility disturbances encountered in the Tube Versus Trabeculectomy (TVT) Study during the first year of follow-up. Design: Multicenter randomized clinical trial. Methods: settings: Seventeen clinical centers. population: Patients 18 to 85 years old who had previous trabeculectomy and/or cataract surgery and uncontrolled glaucoma with intraocular pressure ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. interventions: 350-mm2 Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). main outcome measures: Preoperative and postoperative evaluation of ocular motility and diplopia. Results: Motility disturbances were detected in 55 patients (28%) at baseline. New-onset persistent diplopia was reported in 5 patients (5%) in the tube group and no patients in the trabeculectomy group at 1 year (P = .06). A new postoperative motility disturbance developed or worsened in 7 patients (9.9%) in the tube group and no patients in the trabeculectomy group during the first year of follow-up (P = .005). Postoperative motility disturbances were also associated with increasing age (P < .001) and right eye surgery (P = .044). Conclusions: Preoperative motility disturbances were common among patients in the TVT Study. New postoperative motility disturbances were more frequent following tube shunt surgery than trabeculectomy with MMC after 1 year of follow-up. © 2009 Elsevier Inc. All rights reserved.

Estudio primario

No clasificado

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

Revista American journal of ophthalmology
Año 2007
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Purpose: To report one-year results of the Tube Versus Trabeculectomy (TVT) Study. Design: Multicenter randomized clinical trial. Methods: setting: 17 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: 350 mm2 Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). main outcome measures: IOP, visual acuity, and reoperation for glaucoma. Results: A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At one year, IOP (mean ± SD) was 12.4 ± 3.9 mm Hg in the tube group and 12.7 ± 5.8 mm Hg in the trabeculectomy group (P = .73). The number of glaucoma medications (mean ± SD) was 1.3 ± 1.3 in the tube group and 0.5 ± 0.9 in the trabeculectomy group (P < .001). The cumulative probability of failure during the first year of follow-up was 3.9% in the tube group and 13.5% in the trabeculectomy group (P = .017). Conclusions: Nonvalved tube shunt surgery was more likely to maintain IOP control and avoid persistent hypotony or reoperation for glaucoma than trabeculectomy with MMC during the first year of follow-up in the TVT Study. Both surgical procedures produced similar IOP reduction at one year, but there was less need for supplemental medical therapy following trabeculectomy with MMC. © 2007 Elsevier Inc. All rights reserved.

Estudio primario

No clasificado

Surgical complications in the tube versus trabeculectomy study during the first year of follow-up

Revista American journal of ophthalmology
Año 2007
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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-mm2 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 trabeculectomy with MMC than nonvalved tube shunt surgery. Serious complications resulting in reoperation and/or vision loss occurred with similar frequency with both surgical procedures. © 2007 by Elsevier Inc. All rights reserved.