Volume 14 Supplement 1

2nd Clinical Trials Methodology Conference: Methodology Matters

Open Access

Comparative study of new imaging technologies for the diagnosis of glaucoma: design and conduct of a multi-centre diagnostic accuracy study

  • Katie Banister1,
  • Jonathan Cook1,
  • Craig Ramsay1,
  • Jennifer Burr2,
  • Rodolfo Hernández1,
  • Kirsty McCormack1,
  • Rupert Bourne3,
  • Mark Batterbury4,
  • David Garway-Heath5 and
  • Augusto Azuara-Blanco6
Trials201314(Suppl 1):O45

https://doi.org/10.1186/1745-6215-14-S1-O45

Published: 29 November 2013

Purpose

The detection and diagnosis of glaucoma is challenging for health professionals. In the UK, approximately 45% of patients are discharged from secondary care after one visit.

Automated imaging technologies are easy to perform and could potentially be used by trained technicians as triage tests for glaucoma diagnosis.

The GATE study aims to compare the diagnostic performance of three technologies, Heidelberg Retina Tomograph (HRT-III), Scanning laser polarimetry (GDx-ECC) and Optical Coherence Tomography (Spectralis), as triage tests in secondary care for glaucoma diagnosis.

Method

Design

Diagnostic accuracy study, comparing 3 imaging techniques for glaucoma diagnosis.

Population

Adult patients, newly referred from community to hospital eye services for suspected glaucoma.

Reference standard

Comprehensive clinical examination by experienced consultant ophthalmologist, including fundus examination and visual field tests.

Sample size

954, each imaged using all three technologies.

Setting

NHS secondary care, UK.

Outcomes

Diagnostic performance measures, economic outcomes.

Data collection

Data uploaded at site via secure web-based data-collection system.

Results

Recruitment commenced April 2011. To date, 874 participants have been enrolled from five UK hospitals. GATE is an on-going research study and will be completed in November 2013.

Discussion

Conducting a multicentre diagnostic accuracy study in ophthalmology is challenging. Problems which were overcome are grouped into: difficulties in site set-up, consensus in agreeing a reference standard and agreeing study processes. Solutions were achieved through careful planning and support from site based staff.

Conclusion

Challenges in setting up and running a large diagnostic accuracy study can be overcome given adequate resource and planning. http://www.abdn.ac.uk/chart/gate.

Authors’ Affiliations

(1)
University of Aberdeen
(2)
University of St Andrews
(3)
Hinchingbrooke Hospital NHS Trust
(4)
Royal Liverpool and Broadgreen University Hospitals NHS Trust
(5)
Moorfields Eye Hospital NHS Foundation Trust
(6)
Queen's University Belfast

Copyright

© Banister et al; licensee BioMed Central Ltd. 2013

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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