Abstract
Purposeto 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. Designmulticentre randomised controlled trial Participantsbetween 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. Methodsparticipants 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 MeasuresThe 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. ResultsAt 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. ConclusionAt 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 registrationHealth Technology Assessment (NIHR-HTA) Programme (Project number: 12/35/38). ISRCTN registry: ISRCTN56878850.
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