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Treatment of Advanced Glaucoma Study: a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma—study protocol

Abstract

Background Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients.

Aim To compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG).

Methods Design: A prospective, pragmatic multicentre randomised controlled trial (RCT).

Setting Twenty-seven UK hospital eye services.

Participants Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss.

Intervention Participants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes).

Main outcome measures The primary outcome is vision-related quality of life measured by the National Eye Institute—Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated.

Results The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years.

Conclusions Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.

Trial registration number ISRCTN56878850, Pre-results.

  • glaucoma
  • treatment medical
  • intraocular pressure
  • clinical trial
  • treatment surgery

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Footnotes

  • Contributors AK leads the trial and is the chief investigator. AAB, JB, TGH, JS, LV, GM, AM, KB and JN are grant-holders and developed the protocol. GF is trial manager and revised the protocol. JH and GM wrote the statistical analysis plan. All authors contributed to this article.

  • Funding Nottingham University Hospitals NHS Trust sponsors the trial and provides the necessary trial insurance. The trial is funded by a grant awarded by the Health Technology Assessment (NIHR HTA) programme (project number 12/35/38).

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests TAGS is funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme (project number 12/35/38). JMB, GM, AM and JMS report grants from NIHR Health Technology Assessment Programme during the conduct of the study. LV reports grants from NIHR HTA Programme during the conduct of the study; and membership of the NIHR Health Technology Assessment Programme and a director of the NIHR Research Design Service. JN reports grants from NIHR HTA during the conduct of the study; personal fees from NIHR Editors Board, other from NIHR HTA General Board, outside the submitted work.

  • Ethics approval The study adheres to the tenets of the Declaration of Helsinki and the principles of Good Clinical Practice (GCP), and is in accordance with all applicable regulatory guidance, including, but not limited to, the Research Governance Framework. TAGS’ protocol and patient-facing documentation were prospectively reviewed and approved by the Derby 1 Research Ethics Committee(ref number 13/EM/00395). Local NHS Research and Development (R&D)approvals were obtained prior to commencement of the trial at the participating sites. An independent data and safety monitoring committee oversees the trial.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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