Evidence map›Paper›PMID 37852765›Full record

Trial reportBMJ open2023

Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of <400µ: a cost-effectiveness analysis from the DIAMONDS trial.

Hema Mistry, Mandy Maredza, Christina Campbell, Noemi Lois, DIAMONDS study group

Registry-linked trialOpen access · goldAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2023. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 33% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

5 authors at 3 institutions in 1 country.

Hema MistryWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK Hema.Mistry@warwick.ac.uk.ORCID 0000-0002-5023-1160
Mandy MaredzaWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Christina CampbellNorthern Ireland Clinical Trials Unit, Belfast, UK.
Noemi LoisDepartment of Ophthalmology, Wellcome-Wolfson Institute for Experimental Medicine, Queens University Belfast, Belfast, UK.
DIAMONDS study group
Queen's University Belfast · GBUniversity Hospitals Coventry and Warwickshire NHS Trust · GBUniversity of Warwick · GB

Funding

Department of Health
6 · The paper itself

Abstract

objectivesTo estimate the economic costs, health-related quality-of-life outcomes and cost-effectiveness of subthreshold micropulse laser (SML) versus standard laser (SL) for the treatment of diabetic macular oedema (DMO) with central retinal thickness (CRT) of <400µ.

designAn economic evaluation was conducted within a pragmatic, multicentre, randomised clinical trial, DIAbetic Macular Oedema aNd Diode Subthreshold.

setting18 UK Hospital Eye Services.

participantsAdults with diabetes and centre involving DMO with CRT<400µ.

interventionsParticipants (n=266) were randomised 1:1 to receive SML or SL.

methodsThe base-case used an intention-to-treat approach conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective. Costs (2019-2020 prices) were collected prospectively over the 2-year follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit of SML in comparison to SL. Sensitivity analyses explored uncertainty and heterogeneity in cost-effectiveness estimates.

resultsOne participant in the SL arm withdrew consent for data to be used; data from the remaining 265 participants were included in analyses. Mean (SE) NHS and PSS costs over 24 months were £735.09 (£111.85) in the SML arm vs £1099.70 (£195.40) in the SL arm (p=0.107). Mean (SE) QALY estimates were 1.493 (0.024) vs 1.485 (0.020), respectively (p=0.780), giving an insignificant difference of 0.008 QALYs. The probability SML is cost-effective at a threshold of £20 000 per QALY was 76%.

conclusionsThere were no statistically significant differences in EQ-5D-5L scores or costs between SML and SL. Given these findings and the fact that SML does not burn the retina, unlike SL and has equivalent efficacy to SL, it may be preferred for the treatment of people with DMO with CRT<400µ. TRIAL REGISTRATION NUMBERS: ISRCTN17742985; NCT03690050.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaAdultCost-Benefit AnalysisCost-Effectiveness AnalysisHumansLasersQuality-Adjusted Life YearsRetinaState Medicinediabetic retinopathyhealth economicsophthalmology

Identifiers

PMID37852765
PMCPMC10603454
OpenAlexW4387748859

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.