Evidence map›Paper›PMID 36541393›Full record

Trial reportHealth technology assessment (Winchester, England)2022

Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT.

Noemi Lois, Christina Campbell, Norman Waugh, Augusto Azuara-Blanco, Mandy Maredza, Hema Mistry, Danny McAuley, Nachiketa Acharya, Tariq M Aslam, Clare Bailey and 17 more

Registry-linked trialOpen access · diamondAbstract readRandomized Controlled TrialMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in Health technology assessment (Winchester, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03690050 (Diabetic Macular Oedema and Diode Subthreshold Micropulse Laser), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.4field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03690050 nacompletednot on this map

Diabetic Macular Oedema and Diode Subthreshold Micropulse Laser (DIAMONDS): A Pragmatic, Multicentre, Allocation Concealed, Prospective, Randomised, Non-inferiority Double-masked Trial

TypeinterventionalSponsorBelfast Health and Social Care TrustRan2014 to 2020Enrolled266ConditionsDiabetic Macular EdemaArmsDiode 577 nm subthreshold micropulse laser, Standard threshold laser (532 nm laser)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 18 institutions in 2 countries.

Noemi LoisThe Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK.ORCID 0000-0003-2666-2937
Christina CampbellNorthern Ireland Clinical Trials Unit (NICTU), Belfast, UK.ORCID 0000-0002-8446-523X
Norman WaughDivision of Health Sciences, University of Warwick, Coventry, UK.ORCID 0000-0003-0934-4961
Augusto Azuara-BlancoCentre for Public Health, Queens University, Belfast, UK.ORCID 0000-0002-4805-9322
Mandy MaredzaDivision of Health Sciences, University of Warwick, Coventry, UK.ORCID 0000-0002-2030-3338
Hema MistryWarwick Clinical Trials Unit, University of Warwick, Coventry, UK.ORCID 0000-0002-5023-1160
Danny McAuleyThe Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK.ORCID 0000-0002-3283-1947
Nachiketa AcharyaSheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.ORCID 0000-0002-0794-689X
Tariq M AslamThe Manchester Academic Health Science Centre, Manchester Royal Eye Hospital, Manchester, UK.ORCID 0000-0002-9739-7280
Clare BaileyBristol Eye Hospital, Bristol, UK.ORCID 0000-0003-2141-4512
Victor ChongRoyal Free Hospital NHS Foundation Trust, London, UK.ORCID 0000-0002-7693-522X
Louise DowneyHull and East Yorkshire Hospital, Hull and East Yorkshire NHS Trust, Hull, UK.ORCID 0000-0001-5944-3437
Haralabos EleftheriadisKing's College Hospital NHS Foundation Trust, London, UK.ORCID 0000-0002-9980-4070
Samia FatumJohn Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.ORCID 0000-0002-5760-4038
Sheena GeorgeHillingdon Hospitals NHS Foundation Trust, London, UK.ORCID 0000-0002-9953-1834
Faruque GhanchiBradford Teaching Hospitals NHS Trust, Bradford, UK.ORCID 0000-0002-4448-8162
Markus GroppeStoke Mandeville Hospital, Buckinghamshire NHS Trust, Aylesbury, UK.ORCID 0000-0003-1963-3484
Robin HamiltonNational Institute for Health and Care Research Moorfields Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.ORCID 0000-0003-2861-8761
Geeta MenonFrimley Park Hospital NHS Foundation Trust, Camberley, UK.ORCID 0000-0001-7532-6564
Ahmed SaadJames Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.ORCID 0000-0002-5159-8001
Sobha SivaprasadNational Institute for Health and Care Research Moorfields Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.ORCID 0000-0001-8952-0659
Marianne ShiewHinchingbrooke Hospital North West Anglia NHS Trust, Huntingdon, UK.ORCID 0000-0003-4774-3576
David H SteelSunderland Eye Infirmary, Sunderland, UK.ORCID 0000-0001-8734-3089
James Stephen TalksNewcastle Eye Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.ORCID 0000-0001-6126-6476
Paul DohertyNorthern Ireland Clinical Trials Unit (NICTU), Belfast, UK.ORCID 0000-0002-3263-7052
Clíona McDowellNorthern Ireland Clinical Trials Unit (NICTU), Belfast, UK.ORCID 0000-0002-7644-7197
Mike ClarkeNorthern Ireland Clinical Trials Unit (NICTU), Belfast, UK.ORCID 0000-0002-2926-7257
Queen's University Belfast · GBUniversity of Warwick · GBMoorfields Eye Hospital NHS Foundation Trust · GBBradford Teaching Hospitals NHS Foundation Trust · GBBristol Eye Hospital · GBFrimley Health NHS Foundation Trust · GBHillingdon Hospitals NHS Foundation Trust · GBHinchingbrooke Hospital · GBHull and East Yorkshire Hospitals NHS Trust · GBJohn Radcliffe Hospital · GBKing's College Hospital NHS Foundation Trust · GBManchester Academic Health Science Centre · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBRoyal Free London NHS Foundation Trust · GBSheffield Teaching Hospitals NHS Foundation Trust · GBStoke Mandeville Hospital · GBSunderland Eye Infirmary · GBZagazig University · EG

Funding

Department of Health
6 · The paper itself

Abstract

backgroundThe National Institute for Health and Care Excellence recommends macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm on optical coherence tomography. The DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser) trial compared standard threshold macular laser with subthreshold micropulse laser to treat diabetic macular oedema suitable for macular laser.

objectivesDetermining the clinical effectiveness, safety and cost-effectiveness of subthreshold micropulse laser compared with standard threshold macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm.

designA pragmatic, multicentre, allocation-concealed, double-masked, randomised, non-inferiority, clinical trial.

settingHospital eye services in the UK.

participantsAdults with diabetes and centre-involving diabetic macular oedema with a central retinal subfield thickness of < 400 µm, and a visual acuity of > 24 Early Treatment Diabetic Retinopathy Study letters (Snellen equivalent > 20/320) in one/both eyes.

interventionsParticipants were randomised 1 : 1 to receive 577 nm subthreshold micropulse laser or standard threshold macular laser (e.g. argon laser, frequency-doubled neodymium-doped yttrium aluminium garnet 532 nm laser); laser treatments could be repeated as needed. Rescue therapy with intravitreal anti-vascular endothelial growth factor therapies or steroids was allowed if a loss of ≥ 10 Early Treatment Diabetic Retinopathy Study letters between visits occurred and/or central retinal subfield thickness increased to > 400 µm.

main outcome measuresThe primary outcome was the mean change in best-corrected visual acuity in the study eye at 24 months (non-inferiority margin 5 Early Treatment Diabetic Retinopathy Study letters). Secondary outcomes included the mean change from baseline to 24 months in the following: binocular best-corrected visual acuity; central retinal subfield thickness; the mean deviation of the Humphrey 10-2 visual field in the study eye; the percentage of people meeting driving standards; and the EuroQol-5 Dimensions, five-level version, National Eye Institute Visual Function Questionnaire - 25 and Vision and Quality of Life Index scores. Other secondary outcomes were the cost per quality-adjusted life-years gained, adverse effects, number of laser treatments and additional rescue treatments.

resultsThe DIAMONDS trial recruited fully ( FUTURE WORK: A trial in people with ≥ 400 µm diabetic macular oedema comparing anti-vascular endothelial growth factor therapy alone with anti-vascular endothelial growth factor therapy and macular laser applied at the time when central retinal subfield thickness has decreased to < 400 µm following anti-vascular endothelial growth factor injections would be of value because it could reduce the number of injections and, subsequently, costs and risks and inconvenience to patients. LIMITATIONS: The majority of participants enrolled had poorly controlled diabetes.

conclusionsSubthreshold micropulse laser was equivalent to standard threshold macular laser but required a slightly higher number of laser treatments.

trial registrationThis trial is registered as EudraCT 2015-001940-12, ISRCTN17742985 and NCT03690050.

fundingThis project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaAdultBevacizumabEndothelial Growth FactorsHumansLaser CoagulationLasersQuality of LifeRanibizumabBevacizumabEndothelial Growth FactorsRanibizumabAFLIBERCEPTANTI-VEGFSBEVACIZUMABCOST-EFFECTIVENESSDIABETESDIABETIC MACULAR EDEMADIABETIC MACULAR OEDEMADMEDMOEQ5DEQ5D-5LLASERMICROPULSENEI VFQ25PHOTOCOAGULATIONQOLQUALITY OF LIFERANDOMISED CLINICAL TRIALRANIBIZUMABRCTSTEROIDSSUBTHRESHOLD LASERVASCULAR ENDOTHELIAL GROWTH FACTORVEGFVISQOL

Identifiers

PMID36541393
PMCPMC9791463
OpenAlexW4313209954

What Socratic holds

Textmetadata
Read underepoch 390

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 Socratic graph.