ArticleTrials2019
Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 26 citations in OpenAlex.
- Trial
- Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT.Health technology assessment (Winchester, England) · 2022Trial
- Management of diabetic macular edema: from anti-VEGF to emerging therapies.Frontiers in medicine · 2026Review
- Micropulse Laser Therapy as an Integral Part of Eye Disease Management.Medicina (Kaunas, Lithuania) · 2023Review
- Subthreshold Micropulse Laser for Diabetic Macular Edema: A Review.Journal of clinical medicine · 2022Review
- Factors affecting the response to subthreshold micropulse laser therapy used in center-involved diabetic macular edema.Lasers in medical science · 2022Article
- Statement of the German Ophthalmological Society, the German Retina Society, and the Professional Association of Ophthalmologists in Germany on treatment of diabetic macular edema : Dated August 2019.Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2021Review
- Article
- Diabetic retinopathy and diabetic macular oedema pathways and management: UK Consensus Working Group.Eye (London, England) · 2020Review
- [Statement of the German Ophthalmological Society, the Retinological Society and the Professional Association of Ophthalmologists in Germany on treatment of diabetic macular edema : Situation August 2019].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2020Review
- Commentary: Subthreshold micropulse yellow laser in diabetic macular edema.Indian journal of ophthalmology · 2020Article
- Subthreshold micropulse laser adjuvant to bevacizumab versus bevacizumab monotherapy in treating diabetic macular edema: one- year- follow-up.Therapeutic advances in ophthalmologyArticle
- Macular laser photocoagulation in the management of diabetic macular edema: Still relevant in 2020?Taiwan journal of ophthalmologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 14 institutions in 2 countries.
Funding
Abstract
backgroundIn 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.
methodsDIAMONDS 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.
trial registrationInternational Standard Randomised Controlled Trials, ISRCTN17742985 . Registered on 19 May 2017 (retrospectively registered).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.