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Primary Trabeculectomy for Advanced Glaucoma: Pragmatic Multicenter Randomized Controlled Trial, or TAGS, represents a useful clinical study for ophthalmologists caring for patients with open-angle glaucoma. This multicenter randomized controlled trial assessed whether primary trabeculectomy or primary medical treatment leads to better outcomes in terms of quality of life, clinical efficacy and safety.
In the UK, the National Institute for Health and Care Excellence (NICE) clinical practice guidelines recommend that primary trabeculectomy should be considered as initial treatment for patients with advanced glaucoma. However, the authors of these guidelines cite minimal supporting evidence. A Cochrane systematic review published in 2012 found that trabeculectomy lowers intraocular pressure more than medical management in patients with open-angle glaucoma, although this study excluded patients with advanced disease. The TAGS group aimed to complement the current literature on the management of patients with advanced glaucoma by studying quality of life, clinical efficacy and safety outcomes. The primary endpoint was vision-specific quality of life using the Visual Function Questionnaire-25 (VFQ-25) at 24 months and secondary endpoints included general health status, glaucoma-related life, clinical effectiveness and safety.
The study team recruited adults with newly diagnosed untreated advanced open-angle glaucoma from 27 centers in the UK. When diagnosed using the Hodapp-Parrish-Anderson classification based on visual field loss, patients with open-angle glaucoma, including pigment-dispersion glaucoma, pseudoexfoliative glaucoma, and normal tension glaucoma, started medical treatment and were randomly assigned to trabeculectomy with mitomycin C or continued medical management. in a 1:1 fashion with the participant (not the eye) as the randomization unit. Due to the interventional design of the study, clinicians and participants were not blinded. In particular, patients at high risk of trabeculectomy failure were excluded from participation. Patients in the trabeculectomy group used medical treatment while awaiting surgery. If patients in the medical treatment group did not show adequate reduction in intraocular pressure despite escalation of treatment including topical and systemic medications, trabeculectomy surgery was offered. Similarly, if trabeculectomy surgery did not adequately control intraocular pressure, surgical patients returned to medical treatment.
The authors recruited 453 participants at 27 clinical sites, with 227 patients in the medical management group and 226 patients in the surgical group, and used an intention-to-treat analysis to assess outcomes. The average age of the participants was 67.6 years. Most patients (82.3%) were Caucasian and 67% of participants were male. The vast majority of participants (97.5%) were diagnosed with primary open-angle glaucoma, including normal tension glaucoma, and most patients (92.5%) were phakic. Nineteen percent of patients in each arm were diagnosed with advanced glaucoma in both eyes. At 24 months, the mean VFQ-25 scores were similar in the two groups. Although the study found a reduction in intraocular pressure for both groups, a greater reduction was seen in patients who underwent trabeculectomy surgery. Mean intraocular pressure was 12.4 mmHg (SD 4.7) for the trabeculectomy group and 15.1 mmHg (SD 4.8) in the medical treatment group, a statistically significant difference (p
The results of the TAGS trial have relevant clinical applications for ophthalmologists caring for patients with open-angle glaucoma who present with advanced disease. Previous studies such as the Moorfield Primary Treatment Trial and the Collaborative Initial Glaucoma Treatment Study (CIGTS) have provided useful insights into the management of patients with newly diagnosed glaucoma, but clinicians may hesitate to offer surgery as the primary treatment.
The current study helps clinicians by demonstrating better intraocular pressure control with primary trabeculectomy surgery and similar outcomes in terms of quality of life, visual field progression, and safety compared to medical therapy. Using the study results, glaucoma specialists can feel more comfortable counseling patients on the option of starting medical management while anticipating prompt surgery when patients present with advanced disease. /severe. Additionally, as in actual clinical practice, the authors allowed crossover so that they escalated medical treatment when inadequate control was achieved and patients in the medical treatment group underwent trabeculectomy surgery if necessary. . Nevertheless, for tertiary care centers, the study population may not be generalizable, as patients may be diagnosed and managed at other clinics and referred to glaucoma specialists after their disease progression with conservative measures, rather than untreated patients with advanced disease initially presenting to a surgeon. clinical.
With an aging population and longer life expectancies than in the past, sustained disease control to maximize functional vision and minimize glaucoma progression has become increasingly important to clinicians. Developing strong patient relationships and explaining management recommendations using evidence-based medicine is essential to clinical encounters, and the TAGS trial provides additional data that can be presented to patients when discussing options. treatment for advanced open-angle glaucoma.