Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS).
King Anthony J, Hudson Jemma, Fernie Gordon, Kernohan Ashleigh, Azuara-Blanco Augusto, Burr Jennifer, Homer Tara, Shabaninejad Hosein, Sparrow John M, Garway-Heath David
AI Summary
For advanced glaucoma, primary trabeculectomy achieved lower eye pressure than medication, with similar quality of life and safety outcomes, suggesting it's a viable initial treatment option.
Abstract
Objective
To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma.
Design
Pragmatic multicentre randomised controlled trial.
Setting
27 secondary care glaucoma departments in the UK.
Participants
453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017.
Interventions
Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months.
Secondary outcomes: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety.
Results
At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval -1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference -2.8 (-3.8 to -1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare.
Conclusion
Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication.
Trial registration: Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.
MeSH Terms
Shields Classification
Key Concepts4
At 24 months, the mean VFQ-25 scores for primary mitomycin C augmented trabeculectomy (n=227) and primary escalating medical management with intraocular pressure reducing drops (n=226) were 85.4 (SD 13.8) and 84.5 (16.3), respectively, with a mean difference of 1.06 (95% confidence interval -1.32 to 3.43; P=0.38), indicating similar vision-specific quality of life outcomes.
At 24 months, the mean intraocular pressure was 12.4 (SD 4.7) mm Hg for primary mitomycin C augmented trabeculectomy (n=227) and 15.1 (4.8) mm Hg for primary escalating medical management with intraocular pressure reducing drops (n=226), with a mean difference of -2.8 (-3.8 to -1.7) mm Hg (P<0.001), demonstrating that primary trabeculectomy achieved a lower intraocular pressure.
Adverse events occurred in 88 (39%) patients in the primary mitomycin C augmented trabeculectomy arm (n=227) and 100 (44%) patients in the primary escalating medical management with intraocular pressure reducing drops arm (n=226), with a relative risk of 0.88 (95% confidence interval 0.66 to 1.17; P=0.37), indicating similar safety outcomes for both treatments in advanced glaucoma.
A pragmatic multicentre randomised controlled trial (TAGS) was conducted across 27 secondary care glaucoma departments in the UK, enrolling 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017.
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