Evaluating Primary Treatment for People with Advanced Glaucoma
Authors: Anthony J. King, Jemma Hudson, Augusto Azuara-Blanco, Jennifer Burr, Ashleigh Kernohan, Tara Homer, Hosein Shabaninejad, John M. Sparrow, David Garway-Heath, Keith Barton, John Norrie, Tracey Davidson, Luke Vale, Graeme MacLennan, Anthony King, Pavi Agrawal, David C. Broadway, Nick Strouthidis, Shenton Chew, Chelvin Sng, Marta Toth, Gus Gazzard, Ahmed Elkarmouty, Eleni Nikita, Giacinto Triolo, Soledad Aguilar-Munoa, Saurabh Goyal, Sheng Lim, Velota Sung, Imran Masood, Nicholas Wride, Amanjeet Sandhu, Elizabeth Hill, John 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 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, Goncalo Almeida, James Tildsley, Augusto Azuara-Blanco, Angela Knox, Simon Rankin, Sara Wilson, Avinash Prabhu, Subhanjan Mukherji, Amit Datta, Alisdair Fern, Joanna Liput, Tim Manners, Josh Pilling, Clare Stemp, Karen Martin, Tracey Nixon, Caroline Cobb, Alan Rotchford, Sikander Sidiki, Atul Bansal, Obaid Kousha, Graham Auger, Mary Freeman
Journal: Ophthalmology (2024)

Purpose to determine whether primary trabeculectomy or medical treatment produces better outcomes in term of quality of life (QoL), clinical effectiveness and safety in patients presenting with advanced glaucoma. Design multicentre randomised controlled trial Participants between June 3, 2014 and May 31, 2017, 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp Classification) were recruited from 27 secondary care glaucoma departments in the UK, 227 were allocated to trabeculectomy and 226 to medical management. Methods participants were randomised on a 1:1 basis to have either mitomycin C augmented trabeculectomy or escalating medical management with intraocular pressure reducing drops as their primary intervention and followed up for 5 years. ISRCTN registry: ISRCTN56878850. Main Outcome Measures The primary outcome was vision-specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 5-years. Secondary outcomes: general health status, glaucoma related QoL, clinical effectiveness [intraocular pressure (IOP), visual field (VF), visual acuity (VA)] and safety. Results At 5 years the mean VFQ-25 in the trabeculectomy and medication arms were 83.3 (SD 15.5) and 81.3 (SD 17.5) respectively, mean difference 1.01, (95% CI -1.99 to 4.00); p=0.51. Mean IOPs were 12.07 ( 5.18) mmHg and 14.76 (4.14) mmHg respectively, mean difference -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) and -16.74 (6.78) dB respectively, mean difference 1.87 (95% CI 0.87 to 2.87) dB, p<0.001. Safety events occurred in 115 (52.2%) in the trabeculectomy arm and 124 (57.9%) in the medication arm, relative risk 0.92 (95% CI 0.72 to 1.19); p=0.54. Serious adverse events were rare. Conclusion At 5 years TAGS has demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients presenting with advanced disease and has a similar safety profile Trial registration Health Technology Assessment (NIHR-HTA) Programme (Project number: 12/35/38). ISRCTN registry: ISRCTN56878850.