Evidence map›Paper›PMID 42570079›Full record

ArticleOphthalmology and therapy2026

Macular Pigment Changes in Patients with Diabetes Mellitus and Without Diabetic Retinopathy.

Alessandro Arrigo, Emanuela Aragona, Gianpaolo Zerbini, Pasquale Aragona, Francesco Bandello

Registry-linked trialAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06582472 (Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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.

NCT06582472 recruitingnot on this map

Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy

Typeobservational_patient_registrySponsorIRCCS Ospedale San RaffaeleRan2023 to 2025Enrolled180ConditionsDiabetic Retinopathy, Diabetic Retinopathy Associated with Type 2 Diabetes MellitusArmsOphthalmological examination including imaging assessments, confocal analysis of cornea, Dynamic Vessel Analyzer (DVA), tear sampling collection, blood sampling collection
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Alessandro ArrigoOphthalmology Unit, Department of Ophthalmology, IRCCS San Raffaele Scientific Institute, via Olgettina 60, 20132, Milan, Italy. alessandro.arrigo@hotmail.com.ORCID http://orcid.org/0000-0003-4715-8414
Emanuela AragonaOphthalmology Unit, Department of Ophthalmology, IRCCS San Raffaele Scientific Institute, via Olgettina 60, 20132, Milan, Italy.
Gianpaolo ZerbiniComplications of Diabetes Unit, Division of Metabolic and Cardiovascular Sciences, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Pasquale AragonaDepartment of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy.
Francesco BandelloOphthalmology Unit, Department of Ophthalmology, IRCCS San Raffaele Scientific Institute, via Olgettina 60, 20132, Milan, Italy.

Funding

HORIZON EUROPE Widening Participation and Strengthening the European Research Area PNRR-MAD-2022-12376008
6 · The paper itself

Abstract

introductionDiabetic retinopathy (DR) is a common complication of diabetes mellitus (DM) and a leading cause of vision impairment in developed countries. Macular pigment optical density (MPOD) assessment provides a non-invasive method for evaluating in vivo changes in macular pigment. In this study, we investigated macular pigment alterations in eyes of patients with type 2 DM without clinically detectable DR using an autofluorescence-based MPOD (AF-MPOD) technique.

methodsThis was an observational, cross-sectional study including patients with type 2 DM without signs of DR and age- and gender-matched healthy controls. Confocal autofluorescence-based MPOD imaging was used to quantify macular pigment changes within the central 6.0° eccentricity. Retinal structural and microvascular alterations were also assessed using optical coherence tomography (OCT) and OCT angiography (OCTA). The primary outcome measure was the quantitative assessment of AF-MPOD parameters. Secondary outcomes included the evaluation of OCT and OCTA alterations and the exploratory identification of distinct imaging phenotypes among diabetic patients.

resultsForty eyes from patients with type 2 DM and 40 control eyes were included. Eyes from patients with DM showed significantly reduced AF-MPOD parameters and lower OCTA vessel density compared with healthy control eyes (all adjusted p < 0.001). Inner retinal thinning was also observed. Glycemic control was inversely associated with AF-MPOD values and vessel density, whereas higher body mass index showed strong associations with AF-MPOD reduction. AF-MPOD parameters remained independently associated with OCTA-derived vascular metrics after multivariable adjustment.

conclusionsOur findings suggest that an early, interconnected neurovascular-metabolic retinal dysfunction may be detectable before the onset of clinically visible DR. AF-MPOD assessment may provide complementary imaging information on early retinal involvement in DM and warrants further validation in longitudinal studies. CLINICAL

trial registrationProtocol ID: PNRR-MAD-2022-12376008; ClinicalTrials.gov Identifier: NCT06582472.

Indexed as

Diabetes mellitusDiabetic retinopathyMacular pigmentMPODOCTOCTA

Identifiers

PMID42570079
PMCPMC13518695

What Socratic holds

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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 Socratic graph.