TY - JOUR
T1 - Evaluating primary treatment for people with advanced glaucoma
T2 - five-year results of the treatment of advanced glaucoma study
AU - King, Anthony J.
AU - Hudson, Jemma
AU - Azuara-Blanco, Augusto
AU - Burr, Jennifer
AU - Kernohan, Ashleigh
AU - Homer, Tara
AU - Shabaninejad, Hosein
AU - Sparrow, John M.
AU - Garway-Heath, David
AU - Barton, Keith
AU - Norrie, John
AU - Davidson, Tracey
AU - Vale, Luke
AU - MacLennan, Graeme
AU - TAGS Study Group∗
N1 - The author(s) have made the following disclosure(s): The TAGS was supported by a Grant from the National Institute of Health and Care Research - Health Technology Assessment Program - 12/35/38. J.H.: Financial support – National Institute for Health Research Health Technology Assessment Programme. A.K.: Financial support – National Institute for Health Research Health Technology Assessment Programme T.H.: Financial support – National Institute for Health Research Health Technology Assessment Programme H.S.: Financial support – National Institute for Health Research Health Technology Assessment Programme J.M.S.: Financial support – National Institute for Health Research Health Technology Assessment Programme D.G.-H.: Consultant – AbbVie, Omikron, Santen, Roche; Financial support – National Institute for Health Research Health Technology Assessment Programme and Efficacy and Mechanism Evaluation (EME) Programme, MRC DPFS, Horizon 2020, Janssen R&D LLC, Santen; Royalties – Heidelberg Engineering; Lecturer – Viatris, Omikron, Novartis, AbbVie; Patent – UCL, Cardiff/UCL, City University of London; Leadership or fiduciary role – European Glaucoma Society, Glaucoma Research Society, Investigative Ophthalmology and Visual Science K.B.: Consultant – iStar, EyeDPharma, Laboratoires Thea, Advanced Ophthamic Innovations, ELT Sight, Sight Sciences, Shifamed/Myra Medical, Tarsier Pharma, Radiance TX; Financial support – Advanced Ophthamic Innovations, AISG, Ahtens Glaucoma Congress, Moroccan Glaucoma Society, ARPS - Singapore; Lecturer – Alcon, Allergan, Laboratoires Thea, Santen Pharmaceutical Co. Ltd.; Patent – National University of Singapore; Leadership or fiduciary role – ELT Sight; Equity owner – Vision Futures Limited, Vision Medical Events Ltd., Aquesys, MedEther Ophthalmology, International Glaucoma Surgery Registry J.N.: Financial support – National Institute for Health Research L.V.: Financial support – National Institute for Health Research Health Technology Assessment Programme G.M.: Financial support – National Institute for Health Research Health Technology Assessment Programme and EME Programme Obtained funding: N/A
PY - 2024/7
Y1 - 2024/7
N2 - 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.
AB - 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.
KW - Intraocular pressure
KW - Open-angle glaucoma
KW - Quality of life
KW - Randomized controlled trial
KW - Visual field loss
U2 - 10.1016/j.ophtha.2024.01.007
DO - 10.1016/j.ophtha.2024.01.007
M3 - Article
C2 - 38199528
AN - SCOPUS:85186194701
SN - 0161-6420
VL - 131
SP - 759
EP - 770
JO - Ophthalmology
JF - Ophthalmology
IS - 7
ER -