Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up
| Autor: | Steven J. Gedde, William J. Feuer, Wei Shi, Kin Sheng Lim, Keith Barton, Saurabh Goyal, Iqbal I.K. Ahmed, James Brandt, Steven Gedde, Michael Banitt, Donald Budenz, Richard Lee, Paul Palmberg, Richard Parrish, Luis Vazquez, Sarah Wellik, Mark Werner, Jeffrey Zink, Anup Khatana, Davinder Grover, Arvind Neelakantan, Ahmed El Karmouty, Renata Puertas, Joseph Panarelli, Kateki Vinod, John Lind, Steven Shields, Pouya Alaghband, Mark Sherwood, Mahmoud Khaimi, Prithvi Sankar, Husam Ansari, Eydie Miller-Ellis, Robert Feldman, Laura Baker, Nicholas Bell, Iqbal Ahmed, Donna Williams, Bruce Prum, Pradeep Ramulu, Henry Jampel, William Feuer, Luz Londono, Joyce Schiffman, Yolanda Silva, Elizabeth Vanner, Philip Chen, Dale Heuer, Kuldev Singh, Martha Wright |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Reoperation Alkylating Agents medicine.medical_specialty Intraocular pressure Visual acuity genetic structures Mitomycin medicine.medical_treatment Visual Acuity Glaucoma Trabeculectomy law.invention Prosthesis Implantation Tonometry Ocular Young Adult 03 medical and health sciences Postoperative Complications 0302 clinical medicine Double-Blind Method Randomized controlled trial law Glaucoma surgery Humans Medicine Glaucoma Drainage Implants Intraocular Pressure Aged Aged 80 and over business.industry Hazard ratio Middle Aged medicine.disease eye diseases Surgery Ophthalmology Treatment Outcome 030221 ophthalmology & optometry Female Implant Visual Fields medicine.symptom business 030217 neurology & neurosurgery Follow-Up Studies |
| Zdroj: | Ophthalmology. 125:650-663 |
| ISSN: | 0161-6420 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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