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Primary trabeculectomy versus primary glaucoma eye drops for newly diagnosed advanced glaucoma: TAGS RCT.
Health Technol Assess. 2021 11; 25(72):1-158.HT

Abstract

BACKGROUND

Patients diagnosed with advanced primary open-angle glaucoma are at a high risk of lifetime blindness. Uncertainty exists about whether primary medical management (glaucoma eye drops) or primary surgical treatment (augmented trabeculectomy) provide the best and safest patient outcomes.

OBJECTIVES

To compare primary medical management with primary surgical treatment (augmented trabeculectomy) in patients with primary open-angle glaucoma presenting with advanced disease in terms of health-related quality of life, clinical effectiveness, safety and cost-effectiveness.

DESIGN

This was a two-arm, parallel, multicentre, pragmatic randomised controlled trial.

SETTING

Secondary care eye services.

PARTICIPANTS

Adult patients presenting with advanced primary open-angle glaucoma in at least one eye, as defined by the Hodapp-Parrish-Anderson classification of severe glaucoma.

INTERVENTION

Primary medical treatment - escalating medical management with glaucoma eye drops. Primary trabeculectomy treatment - trabeculectomy augmented with mitomycin C.

MAIN OUTCOME MEASURES

The primary outcome was health-related quality of life measured with the Visual Function Questionnaire-25 at 2 years post randomisation. Secondary outcomes were mean intraocular pressure; EQ-5D-5L; Health Utilities Index 3; Glaucoma Utility Index; cost and cost-effectiveness; generic, vision-specific and disease-specific health-related quality of life; clinical effectiveness; and safety.

RESULTS

A total of 453 participants were recruited. The mean age of the participants was 67 years (standard deviation 12 years) in the trabeculectomy arm and 68 years (standard deviation 12 years) in the medical management arm. Over 65% of participants were male and more than 80% were white. At 24 months, the mean difference in Visual Function Questionnaire-25 score was 1.06 (95% confidence interval -1.32 to 3.43; p = 0.383). There was no evidence of a difference between arms in the EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index. At 24 months, the mean intraocular pressure was 12.40 mmHg in the trabeculectomy arm and 15.07 mmHg in the medical management arm (mean difference -2.75 mmHg, 95% confidence interval -3.84 to -1.66 mmHg; p < 0.001). Fewer types of glaucoma eye drops were required in the trabeculectomy arm. LogMAR visual acuity was slightly better in the medical management arm (mean difference 0.07, 95% confidence interval 0.02 to 0.11; p = 0.006) than in the trabeculectomy arm. There was no evidence of difference in safety between the two arms. A discrete choice experiment updated the utility values for the Glaucoma Utility Index. The within-trial economic analysis found a small increase in the mean EQ-5D-5L score (0.04) and that trabeculectomy has a higher probability of being cost-effective than medical management. The incremental cost of trabeculectomy per quality-adjusted life-year was £45,456. Therefore, at 2 years, surgery is unlikely to be considered cost-effective at a threshold of £20,000 per quality-adjusted life-year. When extrapolated over a patient's lifetime in a model-based analysis, trabeculectomy, compared with medical treatment, was associated with higher costs (average £2687), a larger number of quality-adjusted life-years (average 0.28) and higher incremental cost per quality-adjusted life-year gained (average £9679). The likelihood of trabeculectomy being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life year gained was 73%.

CONCLUSIONS

Our results suggested that there was no difference between treatment arms in health-related quality of life, as measured with the Visual Function Questionnaire-25 at 24 months. Intraocular pressure was better controlled in the trabeculectomy arm, and this may reduce visual field progression. Modelling over the patient's lifetime suggests that trabeculectomy may be cost-effective over the range of values of society's willingness to pay for a quality-adjusted life-year.

FUTURE WORK

Further follow-up of participants will allow us to estimate the long-term differences of disease progression, patient experience and cost-effectiveness.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN56878850.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 72. See the NIHR Journals Library website for further project information.

Authors+Show Affiliations

Department of Ophthalmology, Nottingham University Hospital, Nottingham, UK.Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.Centre for Public Health, Queen's University Belfast, Belfast, UK.School of Medicine, Medical and Biological Sciences, University of St Andrews, St Andrews, UK.Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.Institute of Ophthalmology, University College London, London, UK. Moorfields Eye Hospital NHS Foundation Trust, London, UK.Institute of Ophthalmology, University College London, London, UK. Moorfields Eye Hospital NHS Foundation Trust, London, UK.Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Pub Type(s)

Journal Article
Multicenter Study
Pragmatic Clinical Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

34854808

Citation

King, Anthony J., et al. "Primary Trabeculectomy Versus Primary Glaucoma Eye Drops for Newly Diagnosed Advanced Glaucoma: TAGS RCT." Health Technology Assessment (Winchester, England), vol. 25, no. 72, 2021, pp. 1-158.
King AJ, Fernie G, Hudson J, et al. Primary trabeculectomy versus primary glaucoma eye drops for newly diagnosed advanced glaucoma: TAGS RCT. Health Technol Assess. 2021;25(72):1-158.
King, A. J., Fernie, G., Hudson, J., Kernohan, A., Azuara-Blanco, A., Burr, J., Homer, T., Shabaninejad, H., Sparrow, J. M., Garway-Heath, D., Barton, K., Norrie, J., McDonald, A., Vale, L., & MacLennan, G. (2021). Primary trabeculectomy versus primary glaucoma eye drops for newly diagnosed advanced glaucoma: TAGS RCT. Health Technology Assessment (Winchester, England), 25(72), 1-158. https://doi.org/10.3310/hta25720
King AJ, et al. Primary Trabeculectomy Versus Primary Glaucoma Eye Drops for Newly Diagnosed Advanced Glaucoma: TAGS RCT. Health Technol Assess. 2021;25(72):1-158. PubMed PMID: 34854808.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Primary trabeculectomy versus primary glaucoma eye drops for newly diagnosed advanced glaucoma: TAGS RCT. AU - King,Anthony J, AU - Fernie,Gordon, AU - Hudson,Jemma, AU - Kernohan,Ashleigh, AU - Azuara-Blanco,Augusto, AU - Burr,Jennifer, AU - Homer,Tara, AU - Shabaninejad,Hosein, AU - Sparrow,John M, AU - Garway-Heath,David, AU - Barton,Keith, AU - Norrie,John, AU - McDonald,Alison, AU - Vale,Luke, AU - MacLennan,Graeme, PY - 2021/12/2/entrez PY - 2021/12/3/pubmed PY - 2022/2/26/medline KW - ADVANCED OPEN-ANGLE GLAUCOMA KW - AUGMENTED TRABECULECTOMY KW - MITOMYCIN C KW - PRIMARY MEDICAL MANAGEMENT KW - QUALITY OF LIFE KW - RANDOMISED CONTROLLED TRIAL SP - 1 EP - 158 JF - Health technology assessment (Winchester, England) JO - Health Technol Assess VL - 25 IS - 72 N2 - BACKGROUND: Patients diagnosed with advanced primary open-angle glaucoma are at a high risk of lifetime blindness. Uncertainty exists about whether primary medical management (glaucoma eye drops) or primary surgical treatment (augmented trabeculectomy) provide the best and safest patient outcomes. OBJECTIVES: To compare primary medical management with primary surgical treatment (augmented trabeculectomy) in patients with primary open-angle glaucoma presenting with advanced disease in terms of health-related quality of life, clinical effectiveness, safety and cost-effectiveness. DESIGN: This was a two-arm, parallel, multicentre, pragmatic randomised controlled trial. SETTING: Secondary care eye services. PARTICIPANTS: Adult patients presenting with advanced primary open-angle glaucoma in at least one eye, as defined by the Hodapp-Parrish-Anderson classification of severe glaucoma. INTERVENTION: Primary medical treatment - escalating medical management with glaucoma eye drops. Primary trabeculectomy treatment - trabeculectomy augmented with mitomycin C. MAIN OUTCOME MEASURES: The primary outcome was health-related quality of life measured with the Visual Function Questionnaire-25 at 2 years post randomisation. Secondary outcomes were mean intraocular pressure; EQ-5D-5L; Health Utilities Index 3; Glaucoma Utility Index; cost and cost-effectiveness; generic, vision-specific and disease-specific health-related quality of life; clinical effectiveness; and safety. RESULTS: A total of 453 participants were recruited. The mean age of the participants was 67 years (standard deviation 12 years) in the trabeculectomy arm and 68 years (standard deviation 12 years) in the medical management arm. Over 65% of participants were male and more than 80% were white. At 24 months, the mean difference in Visual Function Questionnaire-25 score was 1.06 (95% confidence interval -1.32 to 3.43; p = 0.383). There was no evidence of a difference between arms in the EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index. At 24 months, the mean intraocular pressure was 12.40 mmHg in the trabeculectomy arm and 15.07 mmHg in the medical management arm (mean difference -2.75 mmHg, 95% confidence interval -3.84 to -1.66 mmHg; p < 0.001). Fewer types of glaucoma eye drops were required in the trabeculectomy arm. LogMAR visual acuity was slightly better in the medical management arm (mean difference 0.07, 95% confidence interval 0.02 to 0.11; p = 0.006) than in the trabeculectomy arm. There was no evidence of difference in safety between the two arms. A discrete choice experiment updated the utility values for the Glaucoma Utility Index. The within-trial economic analysis found a small increase in the mean EQ-5D-5L score (0.04) and that trabeculectomy has a higher probability of being cost-effective than medical management. The incremental cost of trabeculectomy per quality-adjusted life-year was £45,456. Therefore, at 2 years, surgery is unlikely to be considered cost-effective at a threshold of £20,000 per quality-adjusted life-year. When extrapolated over a patient's lifetime in a model-based analysis, trabeculectomy, compared with medical treatment, was associated with higher costs (average £2687), a larger number of quality-adjusted life-years (average 0.28) and higher incremental cost per quality-adjusted life-year gained (average £9679). The likelihood of trabeculectomy being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life year gained was 73%. CONCLUSIONS: Our results suggested that there was no difference between treatment arms in health-related quality of life, as measured with the Visual Function Questionnaire-25 at 24 months. Intraocular pressure was better controlled in the trabeculectomy arm, and this may reduce visual field progression. Modelling over the patient's lifetime suggests that trabeculectomy may be cost-effective over the range of values of society's willingness to pay for a quality-adjusted life-year. FUTURE WORK: Further follow-up of participants will allow us to estimate the long-term differences of disease progression, patient experience and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56878850. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 72. See the NIHR Journals Library website for further project information. SN - 2046-4924 UR - https://www.unboundmedicine.com/medline/citation/34854808/Primary_trabeculectomy_versus_primary_glaucoma_eye_drops_for_newly_diagnosed_advanced_glaucoma:_TAGS_RCT_ DB - PRIME DP - Unbound Medicine ER -