PURPOSE: To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up.
DESIGN: Multicenter, prospective randomized clinical trial.
METHODS: setting: Sixteen international clinical centers.
STUDY POPULATION: Two hundred seventy-six subjects aged 18-85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of >18 mm Hg.
INTERVENTIONS: Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101-350.
MAIN OUTCOME MEASURES: Late postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications.
RESULTS: Late complications developed in 56 subjects (46.8 ± 4.8 5-year cumulative % ± SE) in the Ahmed Glaucoma Valve group and 67 (56.3 ± 4.7 5-year cumulative % ± SE) in the Baerveldt Glaucoma Implant group (P = .082). The cumulative rates of serious complications were 15.9% and 24.7% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = .034), although this was largely driven by subjects who had tube occlusions in the 2 groups (0.8% in the Ahmed Glaucoma Valve group and 5.7% in the Baerveldt Glaucoma Implant group, P = .037). Both groups had a relatively high incidence of persistent diplopia (12%) and corneal edema (20%), although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt. The incidence of tube erosion was 1% and 3% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = .04).
CONCLUSIONS: Long-term rates of vision-threatening complications and complications resulting in reoperation were higher in the Baerveldt Glaucoma Implant than in the Ahmed Glaucoma Valve group over 5 years of follow-up.
OBJETIVO: El objetivo de este estudio fue evaluar de forma prospectiva la seguridad y eficacia del dispositivo valvulado de Ahmed modelo M4 (sistema valvular convencional en plato de polietileno poroso de alta densidad, Medpor) comparado con el modelo S2 (plato de polipropileno). MÉTODO: Se formaron 2 grupos de pacientes con glaucoma neovascular. Un grupo en el que se implantó el dispositivo M4 y el grupo en el que se implantó el dispositivo S2. En ambos grupos (M4 y S2) se incluyó a pacientes mestizos mexicanos. Dichos pacientes fueron intervenidos quirúrgicamente, utilizando la técnica convencional consistente en la fijación escleral del cuerpo valvular en el cuadrante temporal superior a 8mm del limbo y realizando un túnel subepiescleral para colocar el tubo del dispositivo dentro de la cámara anterior, de acuerdo con la técnica descrita por nuestro grupo en forma previa. Después de un año de seguimiento los resultados fueron evaluados tomando en cuenta la reducción de la presión intraocular (PIO), los cambios en la agudeza visual, el uso de hipotensores oculares complementarios y las complicaciones aparecidas, así como las características demográficas de cada grupo. En el caso del modelo M4, los procedimientos quirúrgicos fueron realizados por el mismo cirujano (FGC). Los pacientes en los que se implantó el modelo S2 fueron operados por diversos cirujanos, incluyendo a FGC, del Servicio de Glaucoma del Hospital Dr. Luis Sánchez Bulnes de la Asociación para Evitar la Ceguera en México (APEC). RESULTADOS: En cada uno de los 2 grupos se operaron 21 ojos de 21 pacientes con diagnóstico de glaucoma neovascular, conformando los 42 ojos incluidos en este estudio. La PIO promedio en el preoperatorio fue de 43,5mmHg (±11,8) para el grupo de M4 y de 42,24mmHg (±12,84) para el grupo de S2. Después de un año de seguimiento, la PIO reportada fue 18,9mmHg (±9,7) para el grupo de M4 y 16,38mmHg (±9,76) para el grupo de S2. CONCLUSIONES: Creemos que es necesario efectuar un mayor número de estudios a largo plazo con un número mayor de pacientes, para poder evaluar la ayuda de esta cubierta porosa en el control tensional de los pacientes con el diagnóstico de GNV
PURPOSE: To prospectively evaluate the effect of early aqueous suppression (therapy) on hypertensive phase (HP) and intraocular pressure (IOP) control after implantation of silicone Ahmed glaucoma valve (AGV).
MATERIALS AND METHODS: Patients who underwent AGV implantation were randomized to initiate therapy (including β-blockers, α-agonists, or carbonic anhydrase inhibitors) when postoperative IOP>10 mm Hg (low-IOP initiation group) or >17 mm Hg (moderate-IOP initiation group). HP was defined as an IOP>21 mm Hg during the first 6 postoperative months, after an initial IOP reduction to <22 mm Hg in the first postoperative week. Primary outcome measures included the occurrence of HP and IOP control.
RESULTS: Fifty-two eyes (50 patients) underwent AGV implantation. Average follow-up was 21.9±10.7 months. HP was observed in 21 eyes (40.4%) with average peak IOP of 30±8 mm Hg, onset at 32±30 days, and duration of 15±32 days. One year postoperatively, those eyes with HP had higher IOP than eyes that did not develop HP (15.1±5.2, 11.4±4.3, respectively; P=0.021) and required more additional glaucoma surgeries (28.6%, 3.2%, respectively; P=0.013). The peak IOP at week 3 postoperatively in the low-IOP initiation group (26 eyes) was significantly lower than in the moderate-IOP initiation group (26 eyes; 15.7±3.6, 20.6±8.9, respectively; P=0.012). Eyes with therapy started after HP onset had significantly higher postoperative IOP from 2 to 4 months. Therapy initiated before the development of HP was not associated with a higher complication rate.
CONCLUSIONS: Aqueous suppression initiated in the early postoperative period while IOPs were still in the low-teens and was able to reduce the incidence of IOP spike associated with the HP without an increased complication rate.
PURPOSE: To evaluate the short-term efficacy of a biodegradable collagen matrix (BCM) as an adjuvant for Ahmed valve implantation surgery to prevent the hypertensive phase.
METHODS: This prospective study included 43 refractory glaucoma eyes, all followed for 6 months. Refractory glaucoma was defined as an IOP higher than 20 mm Hg with antiglaucoma eye drops without previous glaucoma surgery. Conventional method was performed in 21 eyes and BCM-augmented Ahmed valve implantation (BAAVI) in 22 eyes. In the BAAVI group, a 10 × 10 × 2-mm BCM was sutured on an Ahmed glaucoma valve FP7 model. Complete success was defined as an IOP of 21 mm Hg or lower (target IOP 1) or 17 mm Hg or lower (target IOP 2) without antiglaucoma medications and qualified success as an IOP of 21 mm Hg or lower with or without medications. Maximal bleb thickness was measured using anterior segment optical coherence tomography images.
RESULTS: The preoperative IOPs and numbers of preoperative antiglaucoma medications were similar for both groups. Complete target IOP 1 success rates were 38.1% and 86.4%, complete target IOP 2 success rates were 19.0% and 59.1%, and qualified success rates were 52.4% and 90.9% in the conventional and BAAVI groups, respectively (P < 0.05). The hypertensive phase rate was lower in the BAAVI group (4.5% vs. 47.6%, P = 0.002). Maximal bleb thickness was increased in the BAAVI group on postoperative days 30 and 180 (P < 0.05).
CONCLUSIONS: Success rates were higher in the BAAVI group than in the conventional group with the change of bleb morphology. Furthermore, use of BCM significantly decreased the need for antiglaucoma medications for at least 6 months postoperatively.
PURPOSE: To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt 101-350 Glaucoma Implant (BGI) (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma.
DESIGN: Multicenter, randomized, controlled clinical trial.
PARTICIPANTS: A total of 276 patients, including 143 in the AGV group and 133 in the BGI group.
METHODS: Patients aged 18 to 85 years with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥18 mmHg in whom glaucoma drainage implant (GDI) surgery was planned were randomized to implantation of an AGV or a BGI.
MAIN OUTCOME MEASURES: Surgical failure, IOP, visual acuity (VA), use of glaucoma medications, and complications.
RESULTS: At 5 years, IOP (mean ± standard deviation [SD]) was 14.7±4.4 mmHg in the AGV group and 12.7±4.5 mmHg in the BGI group (P = 0.015). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2±1.4 in the AGV group and 1.8±1.5 in the BGI group (P = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group (P = 0.65). The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures; P = 0.003). Eleven eyes in the AGV group (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared with 22 eyes (47% of failures) in the BGI group. Change in logarithm of the minimum angle of resolution VA (mean ± SD) at 5 years was 0.42±0.99 in the AGV group and 0.43±0.84 in the BGI group (P = 0.97).
CONCLUSIONS: Similar rates of surgical success were observed with both implants at 5 years. The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV, but the BGI was associated with twice as many failures because of safety issues.
OBJECTIVE: To evaluate the effect of early aqueous suppressant treatment on Ahmed glaucoma valve (AGV) surgery outcomes.
DESIGN: Randomized clinical trial.
PARTICIPANTS: Ninety-four eyes of 94 patients with refractory glaucoma.
METHODS: After AGV implantation, 47 cases (group 1) received topical timolol-dorzolamide fixed-combination drops twice daily when intraocular pressure (IOP) exceeded 10 mmHg, whereas 47 controls (group 2) received conventional stepwise treatment when IOP exceeded target pressure.
MAIN OUTCOME MEASURES: Main outcome measures included IOP and success rate (6 mmHg < IOP < 15 mmHg and IOP reduction of at least 30% from baseline). Other outcome measures included best-corrected visual acuity, complications, and hypertensive phase frequency.
RESULTS: Groups 1 and 2 were both followed up for a mean of 45±11.6 and 47.2±7.4 weeks, respectively (P = 0.74). Mixed model analysis revealed a significantly greater IOP reduction in group 1 at all intervals (P<0.001). At 1 year, the cases exhibited a significantly higher success rate (63.2% vs. 33.3%; P = 0.008) and reduced hypertensive phase frequency (23.4% vs. 66.0%; P<0.001).
CONCLUSIONS: Early aqueous suppressant treatment may improve AGV implantation outcomes in terms of IOP reduction, success rate, and hypertensive phase frequency.
PURPOSE: To compare 3-year outcomes and complications of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt Glaucoma Implant (BGI) 101-350 (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma.
DESIGN: Multicenter, randomized, controlled clinical trial.
PARTICIPANTS: A total of 276 patients: 143 in the AGV group and 133 in the BGI group.
METHODS: Patients aged 18 to 85 years with refractory glaucoma and intraocular pressures (IOPs) ≥ 18 mmHg in whom an aqueous shunt was planned were randomized to an AGV or a BGI.
MAIN OUTCOME MEASURES: The IOP, visual acuity (VA), supplemental medical therapy, complications, and failure (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).
RESULTS: At 3 years, IOP (mean ± standard deviation) was 14.3 ± ± 4.7 mmHg (AGV group) and 13.1 ± 4.5 mmHg (BGI group) (P = 0.086) on 2.0 ± 1.4 and 1.5 ± 1.4 glaucoma medications, respectively (P = 0.020). The cumulative probabilities of failure were 31.3% (standard error [SE], 4.0%) (AGV) and 32.3% (4.2%) (BGI) (P = 0.99). Postoperative complications associated with reoperation or vision loss of >2 Snellen lines occurred in 24 patients (22%) (AGV) and 38 patients (36%) (BGI) (P = 0.035). The mean change in the logarithm of the minimum angle of resolution VA at 3 years was similar (AGV: 0.21 ± 0.88, BGI: 0.26 ± 0.74) in the 2 treatment groups at 3 years (P = 0.66). The cumulative proportion of patients (SE) undergoing reoperation for glaucoma before the 3-year postoperative time point was 14.5% (3.0%) in the AGV group compared with 7.6% (2.4%) in the BGI group (P = 0.053, log rank). The relative risk of reoperation for glaucoma in the AGV group was 2.1 times that of the BGI group (95% confidence interval, 1.0-4.8; P = 0.045, Cox proportional hazards regression).
CONCLUSIONS: Implantation of the AGV was associated with the need for significantly greater adjunctive medication to achieve equal success relative to implantation of the BGI and resulted in a greater relative risk of reoperation for glaucoma. More subjects experienced serious postoperative complications in the BGI group than in the AGV group.
