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DIAbetic macular oedema aNd diode subthreshold micropulse laser (DIAMONDS) : Ppotocol for a randomised clinical trial
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DIAMONDS Study Group (Including:
). (2019) DIAbetic macular oedema aNd diode subthreshold micropulse laser (DIAMONDS) : Ppotocol for a randomised clinical trial. Trials, 20 . 122. doi:10.1186/s13063-019-3199-5 ISSN 1745-6215.
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WRAP-diabetic-macular-oedema-diode-micropulse-laser-Waugh-2019.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (787Kb) | Preview |
Official URL: https://doi.org/10.1186/s13063-019-3199-5
Abstract
Background
In the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST) < 400 μm, as per National Institute for Health and Care Excellence guidelines. It remains unclear whether subthreshold micropulse laser is superior and should replace standard threshold laser for the treatment of eligible patients.
Methods
DIAMONDS is a pragmatic, multicentre, allocation-concealed, randomised, equivalence, double-masked clinical trial that aims to determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser compared with standard threshold laser, for the treatment of diabetic macular oedema with CST < 400 μm. The primary outcome is the mean change in best-corrected visual acuity in the study eye from baseline to month 24 post treatment. Secondary outcomes (at 24 months) include change in binocular best corrected visual acuity; CST; mean deviation of the Humphrey 10–2 visual field; change in percentage of people meeting driving standards; European Quality of Life-5 Dimensions, National Eye Institute Visual Functioning Questionnaire-25 and VisQoL scores; incremental cost per quality-adjusted life year gained; side effects; number of laser treatments and use of additional therapies.
The primary statistical analysis will be per protocol rather than intention-to-treat analysis because the latter increases type I error in non-inferiority or equivalence trials. The difference between lasers for change in best-corrected visual acuity (using 95% CI) will be compared to the permitted maximum difference of five Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Linear and logistic regression models will be used to compare outcomes between treatment groups. A Markov-model-based cost-utility analysis will extend beyond the trial period to estimate longer-term cost-effectiveness.
Discussion
This trial will determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser, when compared with standard threshold laser, for the treatment of diabetic macular oedema, the main cause of sight loss in people with diabetes mellitus.
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RE Ophthalmology | ||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Retina -- Diseases, Diabetic retinopathy, Diabetes -- Complications | ||||||
| Journal or Publication Title: | Trials | ||||||
| Publisher: | Biomed Central | ||||||
| ISSN: | 1745-6215 | ||||||
| Official Date: | 12 February 2019 | ||||||
| Dates: |
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| Volume: | 20 | ||||||
| Article Number: | 122 | ||||||
| DOI: | 10.1186/s13063-019-3199-5 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Copyright Holders: | The Authors | ||||||
| Date of first compliant deposit: | 29 April 2019 | ||||||
| Date of first compliant Open Access: | 29 April 2019 | ||||||
| RIOXX Funder/Project Grant: |
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