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Donald L Budenz - One of the best experts on this subject based on the ideXlab platform.
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Tube fenestrations in Baerveldt Glaucoma Implant surgery: 1-year results compared with standard Implant surgery.
Journal of Glaucoma, 2020Co-Authors: Geoffrey T. Emerick, Steven J Gedde, Donald L BudenzAbstract:PurposeTo evaluate the efficacy and safety of tube fenestrations in eyes undergoing polyglactin suture-ligated Baerveldt Glaucoma Implant surgery.Patients and MethodsThe authors performed a retrospective nonrandomized comparative interventional study of consecutive cases of 111 eyes of 111 patients
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Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up
American Journal of Ophthalmology, 2015Co-Authors: Donald L Budenz, Steven J Gedde, William J Feuer, Keith Barton, Joyce C. Schiffman, Vital P. Costa, David G. Godfrey, Yvonne M. Buys, Fouad E. SayyadAbstract: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.
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combined pars plana vitrectomy and Baerveldt Glaucoma Implant placement for refractory Glaucoma
International Journal of Ophthalmology, 2015Co-Authors: Thalmon R Campagnoli, Donald L Budenz, Steven J Gedde, William E Smiddy, Richard K Parrish, Paul Palmberg, William J FeuerAbstract:To evaluate outcomes of combined pars plana vitrectomy and Baerveldt Glaucoma Implant (PPV-BGI) placement for refractory Glaucoma.The medical records of 92 eyes (89 patients) that underwent PPV-BGI were retrospectively reviewed, including 43 eyes with neovascular Glaucoma (NVG) and 49 eyes with other types of Glaucoma (non-NVG).Outcome measures were visual acuity (VA), intraocular pressure (IOP), Glaucoma medical therapy, complications, and success [VA>hand motions (HM), IOP≥6 mm Hg and ≤21 mm Hg, no subsequent Glaucoma surgery]. Cumulative success rates for the non-NVG group and NVG group were 79% and 40% at 1y, respectively (P=0.038). No difference in the rates of surgical success were found between pars plana and anterior chamber tube placement. Preoperative IOP (mean±SD) was 30.3±11.7 mm Hg in the Non-NVG group and 40.0±10.6 mm Hg in the NVG group, and IOP was reduced to 15±9.5 mm Hg in the non-NVG group and 15±10.5 mm Hg in the NVG at 1y. Number of Glaucoma medications (mean±SD) decreased from 2.7±1.3 in the non-NVG group and 2.8±1.3 in the NVG group preoperatively to 0.76±1.18 in the non-NVG group and 0.51±1.00 in the NVG group at 1y. Improvement in VA of ≥2 Snellen lines was observed in 25 (27%) eyes, although only 33% of non-NVG eyes and 2.3% of NVG eyes maintained VA better than 20/200 at 1y. Nonclearing vitreous hemorrhage was the most common postoperative complication occurring in 16 (17%) eyes, and postoperative suprachoroidal hemorrhages developed in 5 (5.4%) eyes.PPV-BGI is a viable surgical option for eyes with refractory Glaucoma, but visual outcomes are frequently poor because of ocular comorbidities, especially in eyes with NVG. The location of tube placement does not influence surgical outcome and should be left to the discretion of the surgeon.
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Three-year treatment outcomes in the Ahmed Baerveldt comparison study.
Ophthalmology, 2014Co-Authors: Keith Barton, Donald L Budenz, William J Feuer, Vital P. Costa, David G. Godfrey, Joyce Schiffman, Yvonne M. BuysAbstract: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. Multicenter, randomized, controlled clinical trial. A total of 276 patients: 143 in the AGV group and 133 in the BGI group. 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. 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). 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). 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. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Treatment Outcomes in the Tube Versus Trabeculectomy (TVT) Study After Five Years of Follow-up
American Journal of Ophthalmology, 2012Co-Authors: Steven J Gedde, James D Brandt, William J Feuer, Joyce C. Schiffman, Leon W. Herndon, Donald L BudenzAbstract: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.
Steven J Gedde - One of the best experts on this subject based on the ideXlab platform.
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Tube fenestrations in Baerveldt Glaucoma Implant surgery: 1-year results compared with standard Implant surgery.
Journal of Glaucoma, 2020Co-Authors: Geoffrey T. Emerick, Steven J Gedde, Donald L BudenzAbstract:PurposeTo evaluate the efficacy and safety of tube fenestrations in eyes undergoing polyglactin suture-ligated Baerveldt Glaucoma Implant surgery.Patients and MethodsThe authors performed a retrospective nonrandomized comparative interventional study of consecutive cases of 111 eyes of 111 patients
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Visual Field Outcomes in the Tube Versus Trabeculectomy (TVT) Study
Ophthalmology, 2020Co-Authors: Swarup S. Swaminathan, William J Feuer, Philip P. Chen, Alessandro A. Jammal, Helen L. Kornmann, Felipe A. Medeiros, Steven J GeddeAbstract:Abstract Purpose To describe visual field outcomes in the Tube Versus Trabeculectomy (TVT) Study. Design Cohort analysis of patients in a multicenter randomized clinical trial. Participants One hundred twenty-two eyes of 122 patients, with 61 eyes in both the tube shunt and trabeculectomy groups. Methods The TVT Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery (350-mm2 Baerveldt Glaucoma Implant) and trabeculectomy with mitomycin C (MMC) (0.4 mg/mL for 2 minutes) in patients with previous cataract and/or Glaucoma surgery. Enrolled patients underwent visual field (VF) testing (Humphrey 24-2 with stimulus III) at baseline and at annual follow-up visits. VFs were deemed reliable and included if false positive rate ≤20% and false negative rate ≤35%. VFs were excluded if visual acuity Main Outcome Measure Rate of MD change during follow-up period. Results A total of 436 reliable VFs were analyzed, with an average of 3.6 VFs per eye. Baseline MD was -13.07±8.4 dB in the tube shunt group and -13.18±8.2 dB in the trabeculectomy group (p=0.99). The rate of change in MD was -0.60 dB/year in the tube group and -0.38 dB/year in the trabeculectomy group (p=0.34). The 95% confidence intervals for the rates of MD change were (-0.77, -0.44 dB/year) in the tube group and (-0.56, -0.20 dB/year) in the trabeculectomy group. No significant difference in MD slope was seen when patients were categorized by percentage of visits with intraocular pressure (IOP) 17.5 mmHg). There was no association between standard deviation of IOPs or range of IOP and MD slope. Univariable and multivariable risk factor analyses identified history of diabetes, elevated IOP, and worse MD as baseline factors associated with more rapid VF loss. Conclusions Slow rates of VF loss were observed after randomized surgical treatment in the TVT Study, but no significant difference in the rate of VF loss was seen after tube shunt Implantation and trabeculectomy with MMC. Patients with diabetes, higher IOP, and more severe VF loss at baseline were at higher risk for VF progression.
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Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up.
Ophthalmology, 2019Co-Authors: Steven J Gedde, William J Feuer, Keith Barton, Saurabh Goyal, Iqbal I K Ahmed, James D BrandtAbstract:To report 3-year results of the Primary Tube Versus Trabeculectomy (PTVT) Study. Unmasked 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 were assigned randomly to treatment with a tube shunt (350-mm2 Baerveldt Glaucoma Implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes). The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for Glaucoma, or loss of light perception vision. Secondary outcome measures included IOP, Glaucoma medical therapy, visual acuity, and surgical complications. The cumulative probability of failure after 3 years of follow-up was 33% in the tube group and 28% in the trabeculectomy group (P = 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9-2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of Glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 in the trabeculectomy group (P < 0.001). Serious complications requiring reoperation or producing loss of 2 or more Snellen lines developed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). There was no significant difference in the rate of surgical failure between the 2 surgical procedures at 3 years. Trabeculectomy with MMC achieved lower IOP with use of fewer Glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study. Serious complications producing vision loss or requiring reoperation occurred with similar frequency after both surgical procedures. Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up
Ophthalmology, 2018Co-Authors: Steven J Gedde, James D Brandt, William J Feuer, Keith Barton, Saurabh Goyal, Iqbal K. Ahmed, Steven Gedde, Michael R BanittAbstract:Purpose To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. Design Multicenter, randomized clinical trial. Participants 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. Methods Patients were enrolled at 16 clinical centers and assigned randomly to treatment with a tube shunt (350-mm 2 Baerveldt Glaucoma Implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes). Main Outcome Measures 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). Results 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, 1.20–5.60). Mean ± standard deviation IOP was 13.8±4.1 mmHg in the tube group and 12.4±4.4 mmHg in the trabeculectomy group at 1 year ( P = 0.01), and the number of Glaucoma medications was 2.1±1.4 in the tube group and 0.9±1.4 in the trabeculectomy group ( P P = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1%) in the tube group and 8 patients (7%) in the trabeculectomy group ( P = 0.03). Conclusions Trabeculectomy with MMC had a higher surgical success rate than tube shunt Implantation after 1 year in the PTVT Study. Lower IOP with use of fewer Glaucoma medications was achieved after trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to trabeculectomy with MMC.
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The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C
Ophthalmology, 2017Co-Authors: Steven J Gedde, William J Feuer, Dale K Heuer, Philip P. Chen, Kuldev Singh, Martha M. Wright, Joyce C. SchiffmanAbstract:Purpose To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study. Design Multicenter randomized clinical trial. Participants Patients with medically uncontrolled Glaucoma and no prior incisional ocular surgery. Methods Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm 2 Baerveldt Glaucoma Implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes). Main Outcome Measures The primary outcome measure is the rate of surgical failure, defined as intraocular pressure (IOP) 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. Secondary outcome measures include IOP, Glaucoma medical therapy, visual acuity, visual fields, and surgical complications. Conclusions Practice patterns vary in the surgical management of Glaucoma, and opinions differ among surgeons regarding the preferred primary operation for Glaucoma. The PTVT Study will provide valuable information comparing the 2 most commonly performed Glaucoma surgical procedures.
William J Feuer - One of the best experts on this subject based on the ideXlab platform.
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Visual Field Outcomes in the Tube Versus Trabeculectomy (TVT) Study
Ophthalmology, 2020Co-Authors: Swarup S. Swaminathan, William J Feuer, Philip P. Chen, Alessandro A. Jammal, Helen L. Kornmann, Felipe A. Medeiros, Steven J GeddeAbstract:Abstract Purpose To describe visual field outcomes in the Tube Versus Trabeculectomy (TVT) Study. Design Cohort analysis of patients in a multicenter randomized clinical trial. Participants One hundred twenty-two eyes of 122 patients, with 61 eyes in both the tube shunt and trabeculectomy groups. Methods The TVT Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery (350-mm2 Baerveldt Glaucoma Implant) and trabeculectomy with mitomycin C (MMC) (0.4 mg/mL for 2 minutes) in patients with previous cataract and/or Glaucoma surgery. Enrolled patients underwent visual field (VF) testing (Humphrey 24-2 with stimulus III) at baseline and at annual follow-up visits. VFs were deemed reliable and included if false positive rate ≤20% and false negative rate ≤35%. VFs were excluded if visual acuity Main Outcome Measure Rate of MD change during follow-up period. Results A total of 436 reliable VFs were analyzed, with an average of 3.6 VFs per eye. Baseline MD was -13.07±8.4 dB in the tube shunt group and -13.18±8.2 dB in the trabeculectomy group (p=0.99). The rate of change in MD was -0.60 dB/year in the tube group and -0.38 dB/year in the trabeculectomy group (p=0.34). The 95% confidence intervals for the rates of MD change were (-0.77, -0.44 dB/year) in the tube group and (-0.56, -0.20 dB/year) in the trabeculectomy group. No significant difference in MD slope was seen when patients were categorized by percentage of visits with intraocular pressure (IOP) 17.5 mmHg). There was no association between standard deviation of IOPs or range of IOP and MD slope. Univariable and multivariable risk factor analyses identified history of diabetes, elevated IOP, and worse MD as baseline factors associated with more rapid VF loss. Conclusions Slow rates of VF loss were observed after randomized surgical treatment in the TVT Study, but no significant difference in the rate of VF loss was seen after tube shunt Implantation and trabeculectomy with MMC. Patients with diabetes, higher IOP, and more severe VF loss at baseline were at higher risk for VF progression.
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Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up.
Ophthalmology, 2019Co-Authors: Steven J Gedde, William J Feuer, Keith Barton, Saurabh Goyal, Iqbal I K Ahmed, James D BrandtAbstract:To report 3-year results of the Primary Tube Versus Trabeculectomy (PTVT) Study. Unmasked 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 were assigned randomly to treatment with a tube shunt (350-mm2 Baerveldt Glaucoma Implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes). The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for Glaucoma, or loss of light perception vision. Secondary outcome measures included IOP, Glaucoma medical therapy, visual acuity, and surgical complications. The cumulative probability of failure after 3 years of follow-up was 33% in the tube group and 28% in the trabeculectomy group (P = 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9-2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of Glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 in the trabeculectomy group (P < 0.001). Serious complications requiring reoperation or producing loss of 2 or more Snellen lines developed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). There was no significant difference in the rate of surgical failure between the 2 surgical procedures at 3 years. Trabeculectomy with MMC achieved lower IOP with use of fewer Glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study. Serious complications producing vision loss or requiring reoperation occurred with similar frequency after both surgical procedures. Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up
Ophthalmology, 2018Co-Authors: Steven J Gedde, James D Brandt, William J Feuer, Keith Barton, Saurabh Goyal, Iqbal K. Ahmed, Steven Gedde, Michael R BanittAbstract:Purpose To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. Design Multicenter, randomized clinical trial. Participants 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. Methods Patients were enrolled at 16 clinical centers and assigned randomly to treatment with a tube shunt (350-mm 2 Baerveldt Glaucoma Implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes). Main Outcome Measures 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). Results 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, 1.20–5.60). Mean ± standard deviation IOP was 13.8±4.1 mmHg in the tube group and 12.4±4.4 mmHg in the trabeculectomy group at 1 year ( P = 0.01), and the number of Glaucoma medications was 2.1±1.4 in the tube group and 0.9±1.4 in the trabeculectomy group ( P P = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1%) in the tube group and 8 patients (7%) in the trabeculectomy group ( P = 0.03). Conclusions Trabeculectomy with MMC had a higher surgical success rate than tube shunt Implantation after 1 year in the PTVT Study. Lower IOP with use of fewer Glaucoma medications was achieved after trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to trabeculectomy with MMC.
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The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C
Ophthalmology, 2017Co-Authors: Steven J Gedde, William J Feuer, Dale K Heuer, Philip P. Chen, Kuldev Singh, Martha M. Wright, Joyce C. SchiffmanAbstract:Purpose To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study. Design Multicenter randomized clinical trial. Participants Patients with medically uncontrolled Glaucoma and no prior incisional ocular surgery. Methods Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm 2 Baerveldt Glaucoma Implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes). Main Outcome Measures The primary outcome measure is the rate of surgical failure, defined as intraocular pressure (IOP) 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. Secondary outcome measures include IOP, Glaucoma medical therapy, visual acuity, visual fields, and surgical complications. Conclusions Practice patterns vary in the surgical management of Glaucoma, and opinions differ among surgeons regarding the preferred primary operation for Glaucoma. The PTVT Study will provide valuable information comparing the 2 most commonly performed Glaucoma surgical procedures.
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Quality of Life in the Tube Versus Trabeculectomy Study
American Journal of Ophthalmology, 2017Co-Authors: Aachal Kotecha, Keith Barton, William J Feuer, Steven J GeddeAbstract:Purpose To report the vision-specific quality-of-life (QoL) outcomes in the Tube Versus Trabeculectomy (TVT) Study. Design Multicenter randomized clinical trial. Methods Setting: Seventeen clinical centers. Study Population: Patients 18–85 years of age with medically uncontrolled Glaucoma who had previous cataract and/or Glaucoma surgery. Interventions: Tube shunt (350-mm 2 Baerveldt Glaucoma Implant) or trabeculectomy with MMC. Main Outcome Measures: Vision-specific QoL using the NEI VFQ-25 and estimation of minimally important differences (MID) were the main outcome measures. Cross-sectional distribution- and anchor-based approaches were used to estimate MID. Clinical anchor measures included the mean deviation (MD) and logMAR visual acuity (VA) measurements. Clinically significant changes in anchor were defined as ≥2 dB MD and ≥0.2 logMAR. Results No significant differences in composite scores were observed between treatment groups, and no significant change in scores were seen over time. Mean (SD; range) values of clinical anchors at baseline were −16.6 (9.3; −32 to −0.5) dB for the surgical eye and 0.2 (0.3; −0.1 to 1.3) logMAR VA in the better-vision eye. For anchor-based cross-sectional analysis, composite score MID (95% CI) was 6.3 (4.6–7.9) for better-eye VA and 1.4 (0.9–1.9) for surgical eye MD. Distribution-based MID for the composite score was 6.0. Conclusions Trabeculectomy and tube shunt surgery had similar impact on patient-reported vision-specific QoL measured using the NEI VFQ-25. In this cohort of patients with advanced Glaucoma, MIDs varied depending on the clinical anchor used. Distribution-based MIDs corresponded well with anchor-based MIDs based on VA measures. The MID values reported here may be useful for others wishing to interpret NEI VFQ-25 scores in their advanced Glaucoma patient cohort.
Paul A Sidoti - One of the best experts on this subject based on the ideXlab platform.
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Suture Stenting of a Tube Fenestration for Early Intraocular Pressure Control Following Baerveldt Glaucoma Implant Surgery
Journal of Glaucoma, 2020Co-Authors: Arkadiy Yadgarov, Paul A Sidoti, Alicia Menezes, Adam Botwinick, Robert A Fargione, Kateki Vinod, Joseph F PanarelliAbstract:To evaluate the efficacy and safety of a tube fenestration stented with a 10-0 polyglactin suture for controlling early postoperative intraocular pressure (IOP) after Baerveldt Glaucoma Implant (BGI) surgery. The medical records of 110 patients (119 eyes) who underwent BGI surgery with a tube fenestration stented with a 10-0 polyglactin suture anterior to an occlusive tube ligature were retrospectively reviewed. Main outcome measures included IOP and number of Glaucoma medications at postoperative day 1, week 1, and weeks 2 to 3 as well as complications occurring before ligature release. Mean±SD preoperative IOP was 30.9±9.3 mm Hg using an average of 3.8±1.1 Glaucoma medications. A statistically significant reduction in IOP and Glaucoma medications was observed at all timepoints during the first 3 postoperative weeks compared with baseline (P<0.001). Mean IOP on postoperative day 1, week 1, and weeks 2 to 3 was 18.4±12.2 mm Hg on no medication, 15.9±9.4 mm Hg on 1.0±1.3 medications, and 16.7±8.2 mm Hg on 1.2±1.5 medications, respectively. In total, 44 eyes (37%) achieved IOP control without Glaucoma medication during period of tube occlusion. The use of a single, monofilament 10-0 polyglactin suture to stent a fenestration proximal to the occlusive ligature of a BGI tube is effective in controlling IOP in the early postoperative period. Hypotony-related complications were infrequent and resolved in all cases with in-office interventions.
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downsizing a Baerveldt Glaucoma Implant for the management of persistent postoperative hypotony a case series
Journal of Glaucoma, 2019Co-Authors: Maria A Mavrommatis, Paul A Sidoti, Sonal Dangda, Joseph F PanarelliAbstract:PURPOSE: The purpose of this study was to describe a surgical technique for treating persistent hypotony after Baerveldt Glaucoma Implant (BGI) surgery. MATERIALS AND METHODS: The medical records of 10 patients with persistent postoperative hypotony who underwent truncation of one or both wings of a previously placed BGI, combined with external ligation of the tube using a polypropylene suture, were retrospectively reviewed. RESULTS: All 10 eyes that underwent BGI truncation and placement of a single, external, nonabsorbable (polypropylene) tube ligature exhibited resolution of hypotony within 24 hours and resolution of choroidal effusions within the first 2 postoperative weeks. The median time interval between primary BGI surgery and truncation was 5 months (range, 1.5 mo to 8 y). Median postrevision follow-up time was 12 months (range, 5 mo to 16.2 y). The mean preoperative intraocular pressure (IOP) was 2.1±1.0 mm Hg, and the mean IOP rose to 29.2±13.9 mm Hg on postoperative day 1. Mean IOP at week 1, month 1, and month 3 was 20.5±10.4, 19.7±11.8, and 18.0±8.2 mm Hg, respectively, using an average of 1.4±1.4 Glaucoma medications at postoperative month 3. Ligature release after BGI revision was performed in 9 (90%) of the 10 patients. The median time to ligature release was 1.5 months (range, 3 wk to 4 y). There was no recurrence of hypotony in any of these patients. At most recent follow-up, the mean IOP was 12.9±6.0 mm Hg on an average of 1.5±1.3 Glaucoma medications. Five patients demonstrated improvement in visual acuity from their prerevision best-corrected visual acuity. CONCLUSIONS: Truncation of one or both wings of a BGI and complete closure of the tube with nonabsorbable, but releasable, suture ligature is an effective and safe method for reversing persistent postoperative hypotony while maintaining IOP control.
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suture stenting of a tube fenestration for early intraocular pressure control after Baerveldt Glaucoma Implant surgery
Journal of Glaucoma, 2018Co-Authors: Arkadiy Yadgarov, Paul A Sidoti, Alicia Menezes, Adam Botwinick, Robert A Fargione, Kateki Vinod, Joseph F PanarelliAbstract:PURPOSE: To evaluate the efficacy and safety of a tube fenestration stented with a 10-0 polyglactin suture for controlling early postoperative intraocular pressure (IOP) after Baerveldt Glaucoma Implant (BGI) surgery. METHODS: The medical records of 110 patients (119 eyes) who underwent BGI surgery with a tube fenestration stented with a 10-0 polyglactin suture anterior to an occlusive tube ligature were retrospectively reviewed. Main outcome measures included IOP and number of Glaucoma medications at postoperative day 1, week 1, and weeks 2 to 3 as well as complications occurring before ligature release. RESULTS: Mean±SD preoperative IOP was 30.9±9.3 mm Hg using an average of 3.8±1.1 Glaucoma medications. A statistically significant reduction in IOP and Glaucoma medications was observed at all timepoints during the first 3 postoperative weeks compared with baseline (P<0.001). Mean IOP on postoperative day 1, week 1, and weeks 2 to 3 was 18.4±12.2 mm Hg on no medication, 15.9±9.4 mm Hg on 1.0±1.3 medications, and 16.7±8.2 mm Hg on 1.2±1.5 medications, respectively. In total, 44 eyes (37%) achieved IOP control without Glaucoma medication during period of tube occlusion. CONCLUSIONS: The use of a single, monofilament 10-0 polyglactin suture to stent a fenestration proximal to the occlusive ligature of a BGI tube is effective in controlling IOP in the early postoperative period. Hypotony-related complications were infrequent and resolved in all cases with in-office interventions.
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Long-term Outcomes and Complications of Pars Plana Baerveldt Implantation in Children.
Journal of Glaucoma, 2017Co-Authors: Kateki Vinod, Joseph F Panarelli, Ronald C Gentile, Paul A SidotiAbstract:The purpose of the study was to report long-term outcomes and complications of Baerveldt Glaucoma Implant (BGI) surgery with pars plana tube insertion in children. The medical records of consecutive aphakic and pseudophakic children (<16 y of age) who underwent BGI surgery with pars plana tube insertion between 1990 and 2013 were retrospectively reviewed. Main outcome measures were intraocular pressure and number of Glaucoma medications. Postoperative complications were recorded. Failure was defined as an intraocular pressure <5 or ≥21 mm Hg (with or without Glaucoma medications), loss of light perception, or need for additional Glaucoma surgery. Thirty-seven children were identified with a mean age of 6.0±4.7 years (range, 4 mo to 14.5 y). Mean follow-up after pars plana BGI surgery was 6.5±3.4 years (range, 9 mo to 12.8 y) for patients who met success criteria. Mean intraocular pressure and mean number of Glaucoma medications at most recent follow-up for patients with successful intraocular pressure control were 13.8±4.1 and 2.3±1.9 mm Hg, respectively. The Kaplan-Meier survival analysis revealed 1-, 3-, 5-, and 7-year success rates of 94.5%, 74.6%, 65.0%, and 45.8%, respectively. Complications included tube exposure in 1 patient (2.7%), tube obstruction in 8 patients (21.6%), and retinal detachment in 9 patients (24.3%). Seventeen patients (45.9%) failed due to inadequate intraocular pressure control, of whom 9 (24.3%) required additional Glaucoma surgery. Although pars plana BGI surgery is a reasonable option for managing refractory Glaucoma in aphakic and pseudophakic children, surgeons must be aware of the potential need for additional Glaucoma surgery and/or posterior segment complications with extended follow-up.
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transscleral diode laser cyclophotocoagulation after Baerveldt Glaucoma Implant surgery
Journal of Glaucoma, 2014Co-Authors: Joseph F Panarelli, Michael R Banitt, Paul A SidotiAbstract:PURPOSE: To evaluate the safety and efficacy of transscleral cyclophotocoagulation (TSCPC) in patients requiring intraocular pressure (IOP) reduction despite prior Baerveldt Glaucoma Implant (BGI) surgery. PARTICIPANTS AND METHODS: Twenty eyes of 20 patients who had previously undergone BGI placement and subsequently underwent TSCPC with the red (810 nm) diode laser between April 2005 and January 2010 were retrospectively reviewed. RESULTS: All patients underwent BGI placement an average of 34.7±24.2 months before TSCPC. The mean follow-up period after TSCPC was 25.6±17.4 months (range, 2.3 to 56.5 mo). IOPs were reduced from a mean of 21.8±4.6 to 10.8±3.2 mm Hg at the most recent follow-up, which represents a 50.2% reduction in mean IOP. Successful postoperative IOP control was achieved in 16 (80%) of 20 patients. The number of Glaucoma medications decreased from 4.2±0.6 to 2.2±1.2. The life-table success rate was 78.6% at 12, 24, and 36 months. Postoperative complications included persistent corneal edema in 1 patient and both persistent corneal edema and cystoid macular edema in another patient. Both patients sustained a >2 line reduction in Snellen visual acuity. CONCLUSIONS: TSCPC is safe and effective in the management of patients requiring IOP reduction after BGI surgery. Although our sample size was limited, the safety profile of TSCPC after BGI seems promising.
Naoki Tojo - One of the best experts on this subject based on the ideXlab platform.
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effects of Baerveldt Glaucoma Implant surgery on corneal endothelial cells of patients with no history of trabeculectomy
Clinical Ophthalmology, 2019Co-Authors: Naoki Tojo, Atsushi Hayashi, Mizuki HamadaAbstract:Purpose: Persistent corneal edema is a serious potential complication of Baerveldt Glaucoma Implant (BGI) surgery. A trabeculectomy reduces the density of corneal endothelial cells. We investigated the effect of BGI surgery on corneal endothelial cells of patients with no history of trabeculectomy. Methods: We retrospectively analyzed 85 eyes of 85 patients who underwent BGI surgery and were followed-up for ≥12 months. We used new criteria for surgical failure. We defined persistent corneal edema or needed additional surgery for changing the tube position due to remarkable reduction in corneal endothelial cells as failure. We compared surgical outcomes with new criteria and the rates of corneal endothelial cell density (ECD) loss after BGI surgery between the anterior chamber insertion (AC) group (n=23) and vitreous cavity insertion (VC) group (n=63). Results: The mean pre-operative ECD values of the AC and VC groups were not significantly different at 2309 ± 498 and 2204 ± 556 (p=0.426). The ECD reduction rate in the AC group was significantly faster than in the VC group. The mean post-operative IOP values significantly decreased in both groups. However, the VC group's surgical outcomes were significantly better than the AC group's (p=0.0241) with the new criteria. Conclusion: The mean of ECD did not decrease significantly after BGI surgery in VC group patients with no history of trabeculectomy. BGI surgery insertion to the vitreous cavity was safe and had much less effect on the ECD decrease compared to insertion to the anterior chamber.
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Effects of Baerveldt Glaucoma Implant Surgery on Corneal Endothelial Cells of Patients with No History of Trabeculectomy.
Clinical Ophthalmology, 2019Co-Authors: Naoki Tojo, Atsushi Hayashi, Mizuki HamadaAbstract:Persistent corneal edema is a serious potential complication of Baerveldt Glaucoma Implant (BGI) surgery. A trabeculectomy reduces the density of corneal endothelial cells. We investigated the effect of BGI surgery on corneal endothelial cells of patients with no history of trabeculectomy. We retrospectively analyzed 85 eyes of 85 patients who underwent BGI surgery and were followed-up for ≥12 months. We used new criteria for surgical failure. We defined persistent corneal edema or needed additional surgery for changing the tube position due to remarkable reduction in corneal endothelial cells as failure. We compared surgical outcomes with new criteria and the rates of corneal endothelial cell density (ECD) loss after BGI surgery between the anterior chamber insertion (AC) group (n=23) and vitreous cavity insertion (VC) group (n=63). The mean pre-operative ECD values of the AC and VC groups were not significantly different at 2309 ± 498 and 2204 ± 556 (p=0.426). The ECD reduction rate in the AC group was significantly faster than in the VC group. The mean post-operative IOP values significantly decreased in both groups. However, the VC group's surgical outcomes were significantly better than the AC group's (p=0.0241) with the new criteria. The mean of ECD did not decrease significantly after BGI surgery in VC group patients with no history of trabeculectomy. BGI surgery insertion to the vitreous cavity was safe and had much less effect on the ECD decrease compared to insertion to the anterior chamber. © 2019 Tojo et al.
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Baerveldt surgery outcomes: anterior chamber insertion versus vitreous cavity insertion
Graefe's Archive for Clinical and Experimental Ophthalmology, 2018Co-Authors: Naoki Tojo, Atsushi Hayashi, Tomoko Consolvo-ueda, Shuichiro YanagisawaAbstract:Purpose We compared the outcomes of Baerveldt Glaucoma Implant (BGI) surgery between vitreous cavity and anterior chamber insertion. Methods We retrospectively analyzed a total of 105 consecutive eyes that underwent BGI surgery and were followed up for ≥ 12 months. BGI surgery was performed via the anterior chamber (AC group 48 eyes) or the pars plana into the vitreous cavity (VC group 57 eyes). Patients’ data were examined at 3, 6, and 12 months, and then every 6 months after surgery. We compared the groups’ intraocular pressure (IOP), success ratio, visual acuity, number of Glaucoma medications, central corneal endothelial cell density (CCECD), reduction ratio of CCECD, and postoperative complications. Results The mean preoperative and postoperative IOP values were not significantly different between the two groups. In the Kaplan-Meier survival plots, there was no significant between-group difference in the success rate ( p = 0.333). The postoperative mean CCECD decreased significantly faster in the AC group than the VC group at all time points. The cases of postoperative corneal edema were 12.5% in AC group and 1.8% in VC group. The risk of postoperative corneal edema was significantly higher in the AC group ( p = 0.0136). Risk factors for the rapid reduction of CCECD were “history of trabeculectomy” ( p = 0.00283), “insertion into the anterior chamber” ( p = 0.001), and “shorter distance between the tube and corneal endothelium” ( p = 0.0137). Conclusion There was no significant between-group difference in postoperative IOP, medications, or success rate. Considering the reduction of corneal endothelial cells, insertion into the vitreous cavity seems safer than insertion into the anterior chamber.
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Baerveldt surgery outcomes: anterior chamber insertion versus vitreous cavity insertion
Graefes Archive for Clinical and Experimental Ophthalmology, 2018Co-Authors: Naoki Tojo, Atsushi Hayashi, Tomoko Consolvo-ueda, Shuichiro YanagisawaAbstract:We compared the outcomes of Baerveldt Glaucoma Implant (BGI) surgery between vitreous cavity and anterior chamber insertion. We retrospectively analyzed a total of 105 consecutive eyes that underwent BGI surgery and were followed up for ≥ 12 months. BGI surgery was performed via the anterior chamber (AC group 48 eyes) or the pars plana into the vitreous cavity (VC group 57 eyes). Patients’ data were examined at 3, 6, and 12 months, and then every 6 months after surgery. We compared the groups’ intraocular pressure (IOP), success ratio, visual acuity, number of Glaucoma medications, central corneal endothelial cell density (CCECD), reduction ratio of CCECD, and postoperative complications. The mean preoperative and postoperative IOP values were not significantly different between the two groups. In the Kaplan-Meier survival plots, there was no significant between-group difference in the success rate (p = 0.333). The postoperative mean CCECD decreased significantly faster in the AC group than the VC group at all time points. The cases of postoperative corneal edema were 12.5% in AC group and 1.8% in VC group. The risk of postoperative corneal edema was significantly higher in the AC group (p = 0.0136). Risk factors for the rapid reduction of CCECD were “history of trabeculectomy” (p = 0.00283), “insertion into the anterior chamber” (p = 0.001), and “shorter distance between the tube and corneal endothelium” (p = 0.0137). There was no significant between-group difference in postoperative IOP, medications, or success rate. Considering the reduction of corneal endothelial cells, insertion into the vitreous cavity seems safer than insertion into the anterior chamber.
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Baerveldt Glaucoma Implant surgery with the double scleral flap technique to prevent hoffman elbow exposure
Graefes Archive for Clinical and Experimental Ophthalmology, 2017Co-Authors: Naoki Tojo, Shuichiro Yanagisawa, Tomoko Uedaconsolvo, Atsushi HayashiAbstract:Objective To compare the efficacy and safety of the Baerveldt® Glaucoma Implant (BGI) between a preserved donor scleral patch alone and double scleral flaps, comprising a preserved donor scleral patch and an autologous scleral pedicle flap.
