The authors would like to specially thank all DIAMONDS trial participants. We thank the NIHR Health Technology Assessment programme for providing funding for the trial. We also thank the UK Ophthalmology Clinical Research Network, and Maurice O’Kane, Julie Silvestri, Jonathan Jackson, Paul Biagioni of the Northern Ireland Ophthalmology Clinical Research Network, as well as Alison Murphy and Lynn Murphy for their support to this trial. We thank Pamela Royle for conducting the literature searches. We thank Danielle Logan (Supporting Statistician, NICTU) for her assistance with the statistical analyses. We would like to thank IRIDEX for providing a free loan for the laser equipment for the trial and William, Moore, Joan Stauffer, George Marcellino (in memoriam), Franz Weingartner, Gareth Hymas, Nick Fitrzyk and Suzanne Kelly, for their support. IRIDEX had no role in the design, data analysis or interpretation of the DIAMONDS trial data or in the writing of this report.
The authors would also like to thank independent TSC members Alistair Laidlaw, Ian Pearce, Tom Rush, and Andrew Elders, and DMEC members Graeme MacLennan, Baljean Dhillon and Tom Williamson.
Ethics approval for the DIAMONDS trial was obtained on 17 August 2016 from the Office for Research Ethics Committees Northern Ireland (ORECNI) (15/NI/0197) prior to the initiation of the trial. A Clinical Trial Authorisation (CTA) was also obtained from the Medicines and Healthcare products Regulatory Agency (MHRA) (32485/0029/001–0001). Informed consent to participate in the study was obtained from all participants. The DIAMONDS trial was conducted in accordance with the World Medical Association Declaration of Helsinki.70
Patient and public involvement
We would like to thank the DIAMONDS PPI Group and especially Martin Adams for providing a patient and public perspective on the design, findings and interpretation of the results of this trial. We thank the members of the ‘Diabetes Family’ Facebook (Meta Platforms, Inc., Menlo Park, CA, USA) group, who provided very important feedback at the time of trial conception. This included the suggestion of adding ‘meeting driving standards’ as an outcome in the trial, after having recognised this to be a very important outcome for people living with diabetes.
DIAMONDS study group
Noemi Lois, Queen’s University and Royal Victoria Hospital, BHSCT; Evie Gardner, NICTU; Norman Waugh, Warwick University; Augusto Azuara-Blanco, Queen’s University and Royal Victoria Hospital, BHSCT; Hema Mistry, Warwick University; Danny McAuley, Queen’s University and Royal Victoria Hospital, BHSCT; Mike Clarke, Queens University; Tariq M Aslam, Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust; Clare Bailey, Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust; Victor Chong, Royal Free Hospital NHS Foundation Trust, London; Sobha Sivaprasad, Moorfields Eye Hospital NHS Foundation Trust; David H Steel, Sunderland Eye Infirmary, City Hospitals Sunderland NHS Foundation Trust; James Stephen Talks, Newcastle Eye Centre, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust; Catherine Adams, NICTU; Christina Campbell, NICTU; Matthew Mills, NICTU; Paul Doherty, NICTU; Aby Joseph, NICTU; Nachiketa Acharya, Sheffield Teaching Hospitals NHS Foundation Trust; Louise Downey, Hull and East Yorkshire Hospital, Hull and East Yorkshire NHS Trust; Haralabos Eleftheriadis, King’s College Hospital NHS Foundation Trust; Samia Fatum, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust; Sheena George, Hillingdon Hospitals NHS Foundation Trust; Faruque Ghanchi, Bradford Teaching Hospitals NHS Trust; Markus Groppe, Stoke Mandeville Hospital, Buckinghamshire NHS Trust; Robin Hamilton, Moorfields Eye Hospital NHS Foundation Trust; Geeta Menon, Frimley Park Hospital NHS Foundation Trust; Ahmed Saad, James Cook University Hospital, South Tees Hospitals NHS Foundation Trust; and Marianne Shiew; Hinchingbrooke Hospital North West Anglia NHS Trust.
Research teams at participating sites
The DIAMONDS trial was a collaborative effort across many sites. We thank all staff at the participating sites for making a valuable contribution to the trial, both in delivering the intervention and in measuring patient outcomes. We are also grateful to those staff at the NICTU who worked on the early phases of the trial, including Catherine Adams, Fiona McCourt, Evie Gardner, Mairead North and Matthew Mills.
Royal Victoria Hospital, Belfast Health and Social Care Trust
Nuala-Jane Lavery, Rebecca Denham, Louise Scullion, Vittorio Silvestri, Lesley Doyle, Graham Young, Kate Graham, Jonathan Jackson, Jonathan Keenan, Georgina Sterret, Deirdre Burns, Claire Maguire and Emma McConnell.
Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust
Geraldine Salahi-Ali, Poppy Lavender and Mona-Lisa Bora.
Frimley Park Hospital NHS Foundation Trust
Clare Denford, Lynda Francis, Manju Chandran (Consultant Ophthalmic Surgeon and Sub Investigator) and Abigail Raguro (Research Nurse).
Hinchingbrooke Hospital, North West Anglia NHS Trust
Debra Jones and Linda Molloy.
King’s College Hospital NHS Foundation Trust
Noimot Timson.
Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust
Stephanie Clarke, Rasia Platt and Sony-Rose Augustine.
Moorfields Eye Hospital NHS Foundation Trust
Samantha Gibson, Taniya Chowdhury, Supeetha David, Tabassum Master, Simona Esposti, Elaina Reid, Tran Dang, Maria Gemenetzi and Filipa Rodriguez.
Newcastle Eye Centre, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
Patricia Day and Violet Andrew.
John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
Janette Savage.
Sheffield Teaching Hospitals NHS Foundation Trust
Helen Pokora.
Sunderland Eye Infirmary, South Tyneside and Sunderland NHS Foundation Trust
Maged Habib, Lauren Gardner and Steve Dodds.
Bradford Royal Infirmary, Bradford Teaching Hospitals NHS Trust
Nicola Hawes, Sarah Moss, Hayley Barker, Zeid Madanat and Farahat Butt.
James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Catherine Williamson and Adele Szekeres.
Hull and East Yorkshire Hospital, Hull and East Yorkshire NHS Trust
Angie Atkinson and Julia Twigger.
Stoke Mandeville Hospital, Buckinghamshire NHS Trust
Judith Abrams.
Hillingdon Hospitals NHS Foundation Trust
Rahila Naureen.
Trial Management Group
The following were members of the TMG for some or all of the duration of the study: Professor Noemi Lois (chief investigator, chair); Professor Augusto Azuara-Blanco, Professor Mike Clarke, Professor Danny McAuley, Mr Paul Doherty, Ms Catherine Adams and Ms Fiona McCourt (trial managers); Mr Matthew Mills and Ms Pauline McElhill (clinical trial co-ordinators); Mr Aby Joseph and Ms Omowumi Odusina (data managers); Mr Mark Wilson (database developer); Ms Christina Campbell, Ms Evie Gardner and Ms Mairead North (statisticians); Professor Norman Waugh (health economist), Dr Hema Mistry and Dr Mandy Maredza (health economists); Ms Nicola Duff and Ms Lesley-Anne Dougan (clinical trial administrators); and Ms Emma McAuley and Mr Ryan Craig (clinical research monitors).
Trial Steering Committee
Mr Alistair Laidlaw (clinician, chair), Mr Andrew Elders (statistician), Mr Ian Pearce (clinician) and Mr Tom Rush (PPI representative).
Data Monitoring and Ethics Committee
Mr Graeme MacLennan (statistician, chair), Professor Baljean Dhillon (clinician) and Professor Tom Williamson (clinician).
Sponsor
BHSCT.
Contributions of authors
Noemi Lois (https://orcid.org/0000-0003-2666-2937) (Clinical Professor of Ophthalmology) is the Chief Investigator for the DIAMONDS trial; led the team of co-applicants, researchers and trial supporting staff; conceived and designed the trial with input from co-applicants; and contributed to the identification, recruitment, examination and treatment of all participants enrolled at the Belfast site, as well as to data collection, analysis and interpretation of the trial findings. She led the drafting of this report, revised it critically for important intellectual content and approved its final draft for submission.
Christina Campbell (https://orcid.org/0000-0002-8446-523X) (Trial Statistician) performed the statistical analyses, assisted with the interpretation of data, contributed to the drafting of the report and critically reviewed it.
Norman Waugh (https://orcid.org/0000-0003-0934-4961) (Professor of Public Health and Health Technology Assessment) and Hema Mistry (https://orcid.org/0000-0002-5023-1160) (Health Economist) contributed to the design of the health economics plan and provided oversight for all aspects of the economic evaluation including its design, conduct, analysis and reporting.
Augusto Azuara-Blanco (https://orcid.org/0000-0002-4805-9322) (Clinical Professor of Ophthalmology) contributed to the design of this trial, to the interpretation of the data and to the critical review of this report.
Mandy Maredza (https://orcid.org/0000-0002-2030-3338) (Health Economist) undertook the economic evaluation, supported by Norman Waugh and Hema Mistry.
Danny McAuley (https://orcid.org/0000-0002-3283-1947) (Clinical Professor and Consultant in Intensive Care Medicine and former Director of the Northern Ireland Clinical Trials Unit) contributed to the design of this trial, the interpretation of the data and the critical review of this report.
Nachiketa Acharya (https://orcid.org/0000-0002-0794-689X) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Tariq M Aslam (https://orcid.org/0000-0002-9739-7280) (Consultant Ophthalmologist) contributed to the design of this trial, the interpretation of the data and the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Clare Bailey (https://orcid.org/0000-0003-2141-4512) (Consultant Ophthalmologist) contributed to the design of this trial, the interpretation of the data and the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Victor Chong (https://orcid.org/0000-0002-7693-522X) (Consultant Ophthalmologist) contributed to the design of this trial, the interpretation of the data and the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Louise Downey (https://orcid.org/0000-0001-5944-3437) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Haralabos Eleftheriadis (https://orcid.org/0000-0002-9980-4070) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Samia Fatum (https://orcid.org/0000-0002-5760-4038) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Sheena George (https://orcid.org/0000-0002-9953-1834) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Faruque Ghanchi (https://orcid.org/0000-0002-4448-8162) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Markus Groppe (https://orcid.org/0000-0003-1963-3484) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Robin Hamilton (https://orcid.org/0000-0003-2861-8761) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Geeta Menon (https://orcid.org/0000-0001-7532-6564) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Ahmed Saad (https://orcid.org/0000-0002-5159-8001) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Sobha Sivaprasad (https://orcid.org/0000-0001-8952-0659) (Consultant Ophthalmologist) contributed to the design of this trial, the interpretation of the data and the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Marianne Shiew (https://orcid.org/0000-0003-4774-3576) (Consultant Ophthalmologist) contributed to the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
David H Steel (https://orcid.org/0000-0001-8734-3089) (Consultant Ophthalmologist) contributed to the design of this trial, the interpretation of the data and the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
James Stephen Talks (https://orcid.org/0000-0001-6126-6476) (Consultant Ophthalmologist) contributed to the design of this trial, the interpretation of the data and the critical review of this report, as well as to the recruitment and evaluation of participants enrolled and followed up in this trial.
Paul Doherty (https://orcid.org/0000-0002-3263-7052) (Trial Manager) provided training and support to sites, co-ordinated and managed the trial, was involved in the management of the study and critically reviewed the manuscript.
Clíona McDowell (https://orcid.org/0000-0002-7644-7197) (Trial Statistician) contributed to the statistical analyses, assisted with the interpretation of data, contributed to the drafting of the statistical sections of the report and critically reviewed it.
Mike Clarke (https://orcid.org/0000-0002-2926-7257) (Professor of Research Methodology at the MRC Methodology Hub and Director of the Northern Ireland Clinical Trials Unit) was involved in the conception and design of this trial, contributed to the interpretation of data and drafting of this report, and revised it critically for important intellectual content.
Publications
Lois N, Gardner E, Waugh N, Azuara-Blanco A, Mistry H, McAuley D, et al. Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial. Trials 2019;20:122.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to available anonymised data or trial materials may be granted following review.
Patient data
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
Disclaimers
This report presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.