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Baerveldt Glaucoma Implant

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Donald L Budenz – 1st expert on this subject based on the ideXlab platform

  • Tube fenestrations in Baerveldt Glaucoma Implant surgery: 1-year results compared with standard Implant surgery.
    Journal of Glaucoma, 2020
    Co-Authors: Geoffrey T. Emerick, Steven J Gedde, Donald L Budenz

    Abstract:

    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

  • Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up
    American Journal of Ophthalmology, 2015
    Co-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. Sayyad

    Abstract:

    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.

  • combined pars plana vitrectomy and Baerveldt Glaucoma Implant placement for refractory Glaucoma
    International Journal of Ophthalmology, 2015
    Co-Authors: Thalmon R Campagnoli, Donald L Budenz, Steven J Gedde, William E Smiddy, Richard K Parrish, Paul Palmberg, William J Feuer

    Abstract:

    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.

Steven J Gedde – 2nd expert on this subject based on the ideXlab platform

  • Tube fenestrations in Baerveldt Glaucoma Implant surgery: 1-year results compared with standard Implant surgery.
    Journal of Glaucoma, 2020
    Co-Authors: Geoffrey T. Emerick, Steven J Gedde, Donald L Budenz

    Abstract:

    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

  • Visual Field Outcomes in the Tube Versus Trabeculectomy (TVT) Study
    Ophthalmology, 2020
    Co-Authors: Swarup S. Swaminathan, William J Feuer, Philip P. Chen, Alessandro A. Jammal, Helen L. Kornmann, Felipe A. Medeiros, Steven J Gedde

    Abstract:

    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.

  • Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up.
    Ophthalmology, 2019
    Co-Authors: Steven J Gedde, William J Feuer, Keith Barton, Saurabh Goyal, Iqbal I K Ahmed, James D Brandt

    Abstract:

    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.

William J Feuer – 3rd expert on this subject based on the ideXlab platform

  • Visual Field Outcomes in the Tube Versus Trabeculectomy (TVT) Study
    Ophthalmology, 2020
    Co-Authors: Swarup S. Swaminathan, William J Feuer, Philip P. Chen, Alessandro A. Jammal, Helen L. Kornmann, Felipe A. Medeiros, Steven J Gedde

    Abstract:

    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.

  • Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up.
    Ophthalmology, 2019
    Co-Authors: Steven J Gedde, William J Feuer, Keith Barton, Saurabh Goyal, Iqbal I K Ahmed, James D Brandt

    Abstract:

    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.

  • Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up
    Ophthalmology, 2018
    Co-Authors: Steven J Gedde, James D Brandt, William J Feuer, Keith Barton, Saurabh Goyal, Iqbal K. Ahmed, Steven Gedde, Michael R Banitt

    Abstract:

    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.