Evaluating Primary Treatment for People with Advanced Glaucoma
Anthony King, Jemma Hudson, Augusto Azuara‐Blanco, Jennifer Burr, Ashleigh Kernohan, Tara Homer, Hosein Shabaninejad, J M Sparrow, David F. Garway‐Heath, Keith Barton, John Norrie, Tracey Davidson, Luke Vale, Graeme MacLennan, Anthony King, Pavi Agrawal, David C. Broadway, Nick Strouthidis, Shenton S.L. Chew, Chelvin C. A. Sng, Márta Tóth, Gus Gazzard, Ahmed Elkarmouty, Eleni Nikita, Giacinto Triolo, Soledad Aguilar-Munoa, Saurabh Goyal, Sheng Yang Lim, Velota Sung, Imran Masood, Nicholas Wride, Amanjeet Sandhu, Elizabeth G. Hill, J M Sparrow, Fiona Grey, Rupert Bourne, Gnanapragasam Nithyanandarajah, Catherine Willshire, Philip Bloom, Faisal Ahmed, Franesca Cordeiro, Laura Crawley, Eduardo Normando, Sally Ameen, Joanna Tryfinopoulou, Alistair Porteous, Gurjeet Jutley, Dimitrios Bessinis, James Kirwan, Shahiba Begum, Anastasios Sepetis, Edward Rule, Richard Thornton, Andrew McNaught, Nitin Anand, Anil Negi, Obaid Kousha, Marta Hovan, Roshini Sanders, Pankaj Kumar Agarwal, Andrew J. Tatham, Leon Au, Eleni Nikita, Cecelia Fenerty, Tanya Karaconji, Brett Drury, Duya Penmol, Ejaz Ansari, Albina Dardzhikova, Reza Moosavi, Richard Imonikhe, Prodromos Kontovourikis, Luke Membrey, Gonçalo Almeida, James Tildsley, Augusto Azuara‐Blanco, Angela Knox, Simon J. Rankin, Sara E. Wilson, Avinash Prabhu, Subhanjan Mukherji, Amit Datta, Alisdair Fern, Joanna Liput, Tim Manners, J B Pilling, Clare Stemp, Karen Martin, Tracey Nixon, Caroline Cobb, Alan Rotchford, Sikander Sidiki, Atul Bansal, Obaid Kousha, Graham Auger, Mary Freeman
Abstract
PURPOSE: To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma. DESIGN: Multicenter randomized controlled trial. PARTICIPANTS: Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management. METHODS: Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years. MAIN OUTCOME MEASURES: The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety. RESULTS: At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], -1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was -2.56 (95% CI, -3.80 to -1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were -14.30 ± 7.14 dB and -16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87-2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72-1.19; P = 0.54). Serious adverse events were rare. CONCLUSIONS: At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.