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1. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 5 Years of Follow-up.

Author

Gedde, Steven, Feuer, William, Lim, Kin, Barton, Keith, Goyal, Saurabh, Ahmed, Iqbal, and Brandt, James

Subjects
Glaucoma surgery, Randomized clinical trial, Trabeculectomy, Tube shunt, Humans, Trabeculectomy, Follow-Up Studies, Glaucoma Drainage Implants, Glaucoma, Intraocular Pressure, Mitomycin, Treatment Outcome
Abstract

PURPOSE: To report 5-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: A total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group. METHODS: Patients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 2 minutes). MAIN OUTCOME MEASURES: The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) > 21 mmHg or reduced < 20% from baseline, IOP ≤ 5 mmHg, reoperation for glaucoma, or loss of light perception. Secondary outcome measures included IOP, glaucoma medical therapy, and visual acuity. RESULTS: The cumulative probability of failure after 5 years of follow-up was 42% in the tube group and 35% in the trabeculectomy group (P = 0.21; hazard ratio = 1.31; 95% confidence interval = 0.86-2.01). At 5 years, IOP (mean ± standard deviation) was 13.4 ± 3.5 mmHg in the tube group and 13.0 ± 5.2 mmHg in the trabeculectomy group (P = 0.52), and the number of glaucoma medications (mean ± standard deviation) was 2.2 ± 1.3 in the tube group and 1.3 ± 1.4 in the trabeculectomy group (P < 0.001). CONCLUSIONS: Trabeculectomy with MMC and tube shunt surgery produced similar IOPs after 5 years of follow-up in the PTVT Study, but fewer glaucoma medications were required after trabeculectomy. No significant difference in the rate of surgical failure was observed between the 2 surgical procedures at 5 years.

Published
2022

2. Postoperative Complications in the Primary Tube Versus Trabeculectomy Study During 5 Years of Follow-up.

Author

Gedde, Steven, Feuer, William, Lim, Kin, Barton, Keith, Goyal, Saurabh, Ahmed, Iqbal, and Brandt, James

Subjects
Glaucoma surgery, Randomized clinical trial, Surgical complications, Trabeculectomy, Tube shunt, Humans, Trabeculectomy, Follow-Up Studies, Intraocular Pressure, Alkylating Agents, Treatment Outcome, Glaucoma Drainage Implants, Glaucoma, Mitomycin, Postoperative Complications, Cataract, Blindness
Abstract

PURPOSE: To describe postoperative complications encountered in the Primary Tube Versus Trabeculectomy (PTVT) Study during 5 years of follow-up. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: A total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group. METHODS: Patients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC, 0.4 mg/ml for 2 minutes). MAIN OUTCOME MEASURES: Surgical complications, reoperations for complications, visual acuity, and cataract progression. RESULTS: Early postoperative complications occurred in 24 patients (19%) in the tube group and 40 patients (34%) in the trabeculectomy group (P = 0.013). Late postoperative complications developed in 27 patients (22%) in the tube group and 32 patients (27%) in the trabeculectomy group (P = 0.37). Serious complications producing vision loss and/or requiring a reoperation were observed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). Cataract progression was seen in 65 patients (52%) in the tube group and 52 patients (44%) in the trabeculectomy group (P = 0.30). Surgical complications were not associated with a higher rate of treatment failure (P = 0.61), vision loss (P = 1.00), or cataract progression (P = 0.77) CONCLUSIONS: A large number of surgical complications were observed in the PTVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than with tube shunt surgery. The rates of late postoperative complications, serious complications, and cataract progression were similar with both surgical procedures after 5 years of follow-up. Surgical complications did not increase the risk of treatment failure, vision loss, or cataract progression.

Published
2022

3. Visual Field Outcomes in the Primary Tube Versus Trabeculectomy Study

Author

Gedde, Steven, Banitt, Michael, Budenz, Donald, Chang, Ta, Lee, Richard, Palmberg, Paul, Parrish, Richard, II, Swaminathan, Swarup, Vazquez, Luis, Wellik, Sarah, Werner, Mark, Zink, Jeffrey, Khatana, Anup, Grover, Davinder, Neelakantan, Arvind, Barton, Keith, Panarelli, Joseph, Sidoti, Paul, Tsai, James, Vinod, Kateki, Goyal, Saurabh, Lind, John, Shields, Steven, Lim, Kin Sheng, Brandt, James, Sherwood, Mark, Khaimi, Mahmoud, Sankar, Prithvi, Ansari, Husam, Miller-Ellis, Eydie, Feldman, Robert, Baker, Laura, Bell, Nicholas, Ahmed, Iqbal, Williams, Donna, Prum, Bruce, Ramulu, Pradeep, Jampel, Henry, Feuer, William, Londono, Luz, Schiffman, Joyce, Shi, Wei, Silva, Yolanda, Vanner, Elizabeth, Chen, Philip, Heuer, Dale, Singh, Kuldev, Wright, Martha, Swaminathan, Swarup S., Jammal, Alessandro A., Medeiros, Felipe A., and Gedde, Steven J.

Published
2024
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6. Comparing Treatment Outcomes from the Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Studies

Author

Gedde, Steven J, Feuer, William J, Chen, Philip P, Heuer, Dale K, Singh, Kuldev, Wright, Martha M, and Groups, Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Study

Subjects
Aged, Alkylating Agents, Female, Glaucoma Drainage Implants, Glaucoma, Open-Angle, Humans, Intraocular Pressure, Male, Middle Aged, Mitomycin, Tonometry, Ocular, Trabeculectomy, Treatment Failure, Treatment Outcome, Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Study Groups, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

Differences in patient characteristics between the PTVT and TVT Studies, including the level of preoperative intraocular pressure, contributed to the differences in surgical failure rates in each trial.

Published
2021

9. Outcomes of Glaucoma Reoperations in the Primary Tube Versus Trabeculectomy Study

Author

Coulon, Sara J., Vanner, Elizabeth A., Gedde, Steven J., Banitt, Michael, Budenz, Donald, Lee, Richard, Palmberg, Paul, Parrish, Richard, II, Vazquez, Luis, Wellik, Sarah, Werner, Mark, Zink, Jeffrey, Khatana, Anup, Grover, Davinder, Neelakantan, Arvind, Barton, Keith, Panarelli, Joseph, Sidoti, Paul, Tsai, James, Vinod, Kateki, Goyal, Saurabh, Lind, John, Shields, Steven, Lim, Kin Sheng, Brandt, James, Sherwood, Mark, Khaimi, Mahmoud, Sankar, Prithvi, Ansari, Husam, Miller-Ellis, Eydie, Feldman, Robert, Baker, Laura, Bell, Nicholas, Ahmed, Iqbal, Williams, Donna, Prum, Bruce, Ramulu, Pradeep, Jampel, Henry, Feuer, William, Londono, Luz, Schiffman, Joyce, Shi, Wei, Silva, Yolanda, Vanner, Elizabeth, Chen, Philip, Heuer, Dale, Singh, Kuldev, and Wright, Martha

Published
2023
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17. Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up

Author

Budenz, Donald L, Feuer, William J, Barton, Keith, Schiffman, Joyce, Costa, Vital P, Godfrey, David G, Buys, Yvonne M, Budenz, Donald, Gedde, Steven J, Sayyad, Fouad El, Herndon, Leon, Godfrey, David, Fellman, Ronald, Robinson, James, Dueker, David, Riedel, Patrick, Samuelson, Thomas, Puertas, Renata, Chew, Paul, Aquino, Cecilia, Solish, Alfred M, Buys, Yvonne, Trope, Graham, Brandt, James D, Lim, Michele, Law, Simon, Costa, Vital, Sarkisian, Steve, Chopra, Vikas, Francis, Brian, Meallet, Mario, Varma, Rohit, Netland, Peter, Salim, Sarwat, Feldman, Robert, Bell, Nicholas, Chen, Philip, Heuer, Dale, Singh, Kuldev, Wright, Martha, Schiffman, Joyce C, Shi, Wei, Ajuria, Luz, and Silva, Yolanda

Subjects
Biomedical and Clinical Sciences, Ophthalmology and Optometry, Neurosciences, Clinical Research, Eye Disease and Disorders of Vision, Neurodegenerative, Eye, Adolescent, Adult, Aged, Aged, 80 and over, Female, Follow-Up Studies, Glaucoma Drainage Implants, Glaucoma, Open-Angle, Humans, Intraocular Pressure, Male, Middle Aged, Postoperative Complications, Prospective Studies, Prosthesis Implantation, Reoperation, Time Factors, Tonometry, Ocular, Visual Acuity, Ahmed Baerveldt Comparison Study Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry, Ophthalmology and optometry
Abstract

PurposeTo compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up.DesignMulticenter, prospective randomized clinical trial.Methodssetting: Sixteen international clinical centers.Study populationTwo hundred seventy-six subjects aged 18-85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of >18 mm Hg.InterventionsAhmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101-350.Main outcome measuresLate postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications.ResultsLate 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).ConclusionsLong-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.

Published
2016

27. Choroidal Changes After Anti-VEGF Therapy in AMD Eyes With Different Types of Macular Neovascularization Using Swept-Source OCT Angiography

Author

Shen, Mengxi, primary, Zhou, Hao, additional, Lu, Jie, additional, Li, Jianqing, additional, Jiang, Xiaoshuang, additional, Trivizki, Omer, additional, Laiginhas, Rita, additional, Liu, Jeremy, additional, Zhang, Qinqin, additional, de Sisternes, Luis, additional, Feuer, William J., additional, O'Brien, Robert, additional, Gregori, Giovanni, additional, Wang, Ruikang K., additional, and Rosenfeld, Philip J., additional

Published
2023
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31. Phosphorylated neurofilament heavy chain is a marker of neurodegeneration in Leber hereditary optic neuropathy (LHON).

Author

Guy, John, Shaw, Gerry, Ross-Cisneros, Fred N, Quiros, Peter, Salomao, Solange R, Berezovsky, Adriana, Carelli, Valerio, Feuer, William J, and Sadun, Alfredo A

Subjects
Eye Disease and Disorders of Vision, Neurosciences, Clinical Research, Aging, Neurodegenerative, Neurological, Adolescent, Adult, Age Distribution, Aged, Animals, Biomarkers, Chickens, Female, Humans, Male, Middle Aged, Nerve Degeneration, Neurofilament Proteins, Optic Atrophy, Hereditary, Leber, Phosphoproteins, Phosphorylation, Titrimetry, Opthalmology and Optometry, Ophthalmology & Optometry
Abstract

PurposeTo determine the profile of neurodegeneration in Leber hereditary optic neuropathy (LHON).MethodsWe quantitated serum levels of phosphorylated neurofilament heavy chain (pNF-H) in a Brazilian pedigree of 16 affected patients and 59 carriers with LHON, both molecularly characterized as harboring the G to A mutation at nucleotide 11,778 of the mitochondrial genome. The association of subject characteristics to pNF-H levels was studied with multiple regression; pNF-H data were square-root transformed to effect normality of distribution of residuals. Relationships between the square-root of pNF-H and age and sex were investigated within groups with Pearson correlation and the two-sample t-test. Linear regression was used to assess the difference between groups and to determine if the relationship of age was different between affected individuals and carriers. Results of plotting pNF-H levels by age suggested a nonlinear, quadratic association so age squared was used in the statistical analysis. ANCOVA was used to assess the influence of age and group on pNF-H levels.ResultsIn the carrier group, there was a significant correlation of square-root pNF-H (mean=0.24 ng/ml(2)) with age (r=0.30, p=0.022) and a stronger correlation with quadratic age (r=0.37, p=0.003). With a higher mean pNF-H (0.33 ng/ml(2)) for the affected group, correlations were of similar magnitude, although they were not statistically significant: age (r=0.22, p=0.42), quadratic age (r=0.22, p=0.45). There was no correlation between age and pNF-H levels (mean=0.34 ng/ml(2)) in the off-pedigree group: age (r=0.03, p=0.87), quadratic age (r=0.04, p=0.84). There was no difference between sexes and pNF-H levels in any of the groups (affected, p=0.65; carriers, p=0.19; off-pedigree, p=0.93).ConclusionsElevated pNF-H released into the serum of some affected LHON patients may suggest that axonal degeneration occurs at some point after loss of visual function. Increases in pNF-H levels of carriers with increasing age, not seen in off-pedigree controls, may suggest subtle subclinical optic nerve degeneration.

Published
2008

43. Contributors

Author

Baalbaki, Nada, Barresi-Thornton, Rebecca, Bouez, Charbel, Burke, Karen E., Damia, Jonn, Draelos, Zoe Diana, Edison, Brenda L., Elias, Peter M., Farris, Patricia K., Feuer, William, Firsowicz, Maya, Friedman, Adam J., Fuller, Bryan B., Goldman, Mitchel P., Green, Barbara A., Grove, Gary L., Haowei Han, Houser, Tim, Hughes, Connor Thomas, Jarrold, Bradley B., Lain, Edward (Ted), Liao, I-Chien, McCormick, Erika, Mehta, Rahul C., Meran, Suzanne Micciantuono, Mowad, Christen M., Namkoong, Jin, Nestor, Mark S., Oblong, John E., Palefsky, Irwin, Panigrahi, Sudipa, Poole, Aleksandra J., Rheins, Lawrence A., Rovito, Holly A., Ruvolo, Eduardo, Schwartz, James R., Smythe, Ciaran, Taglia, Lauren N., Thornfeldt, Carl R., Trivedi, Radhika, Wootten, Shaun, Yousefian, Faraz, and Zheng, Qian

Published
2025
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