Evidence map›Paper›PMID 36587174›Full record

ArticleInternational ophthalmology2023

A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol.

Anna Maria Roszkowska, Giuseppe Lombardo, Rita Mencucci, Vincenzo Scorcia, Giuseppe Giannaccare, Annarita Vestri, Danilo Alunni Fegatelli, Giuseppe Massimo Bernava, Sebastiano Serrao, Marco Lombardo

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in International ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05457647 (Assessment of Theranostic Guided Riboflavin/UV-A Corneal Cross-linking for Treatment of Keratoconus), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 22% 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.

NCT05457647 nacompletednot on this map

Assessment of Theranostic Guided Riboflavin/UV-A Corneal Cross-linking for Treatment of Keratoconus

TypeinterventionalSponsorRegensightRan2022 to 2024Enrolled50ConditionsKeratoconusArmsRiboflavin/UV-A corneal cross-linking
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. [Controllability and predictability of riboflavin-ultraviolet A collagen cross-linking: advances in experimental techniques and theoretical research].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2025
    Review
  4. Article
  5. 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

10 authors at 6 institutions in 2 countries.

Anna Maria RoszkowskaOphthalmology Department, Faculty of Medicine, Health Sciences of Andrzej Frycz Modrzewski Krakow University, Gustawa Herlinga-Grudzińskiego 1, 30-705, Krakow, Poland. aroszkowska@afm.edu.pl.ORCID https://orcid.org/0000-0002-8083-3437
Giuseppe LombardoCNR-IPCF, Istituto per I Processi Chimico-Fisici, Viale F. Stagno D'Alcontres 37, 98158, Messina, Italy.
Rita MencucciSOD Oculistica, AOU Careggi, Università di Firenze, Largo Brambilla 3, 50134, Florence, Italy.
Vincenzo ScorciaUO Oculistica, AOU Mater Domini, Università Magna Graecia di Catanzaro, Viale Europa, 88100, Catanzaro, Italy.
Giuseppe GiannaccareUO Oculistica, AOU Mater Domini, Università Magna Graecia di Catanzaro, Viale Europa, 88100, Catanzaro, Italy.
Annarita VestriDipartimento di Sanità Pubblica e Malattie Infettive, Università di Roma "La Sapienza", Piazzale Aldo Moro 5, 00185, Rome, Italy.
Danilo Alunni FegatelliDipartimento di Sanità Pubblica e Malattie Infettive, Università di Roma "La Sapienza", Piazzale Aldo Moro 5, 00185, Rome, Italy.
Giuseppe Massimo BernavaCNR-IPCF, Istituto per I Processi Chimico-Fisici, Viale F. Stagno D'Alcontres 37, 98158, Messina, Italy.
Sebastiano SerraoStudio Italiano di Oftalmologia, Via Livenza 3, 00198, Rome, Italy.
Marco LombardoStudio Italiano di Oftalmologia, Via Livenza 3, 00198, Rome, Italy.
Institute for Chemical and Physical Processes · ITMagna Graecia University · ITSapienza University of Rome · ITStudio Associato Gaia · ITUniversity of Florence · ITUniversity of Messina · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Assessment of theranostic guided riboflavin/UV-A corneal cross-linking for treatment of keratoconus (ARGO; registration number NCT05457647) clinical trial tests the hypothesis that theranostic-guided riboflavin/UV-A corneal cross-linking (CXL) can provide predictable clinical efficacy for halting keratoconus progression, regardless of treatment protocol, i.e., either with or without epithelial removal. Theranostics is an emerging therapeutic paradigm of personalized and precision medicine that enables real-time monitoring of image-guided therapy. In this trial, the theranostic software module of a novel UV-A medical device will be validated in order to confirm its accuracy in estimating corneal cross-linking efficacy in real time. During CXL procedure, the theranostic UV-A medical device will provide the operator with an imaging biomarker, i.e., the theranostic score, which is calculated by non-invasive measurement of corneal riboflavin concentration and its UV-A light mediated photo-degradation. ARGO is a randomized multicenter clinical trial in patients aged between 18 and 40 years with progressive keratoconus aiming to validate the theranostic score by assessing the change of the maximum keratometry point value at 1-year postoperatively. A total of 50 participants will be stratified with allocation ratio 1:1 using a computer-generated stratification plan with blocks in two treatment protocols, such as epithelium-off or epithelium-on CXL. Following treatment, participants will be monitored for 12 months. Assessment of safety and performance of theranostic-guided corneal cross-linking treatment modality will be determined objectively by corneal tomography, corneal endothelial microscopy, visual acuity testing and slit-lamp eye examination.

Indexed as

KeratoconusPhotochemotherapyAdolescentAdultCorneaCorneal Cross-LinkingCorneal TopographyCross-Linking ReagentsHumansMulticenter Studies as TopicPhotosensitizing AgentsPrecision MedicineRandomized Controlled Trials as TopicRiboflavinUltraviolet RaysYoung AdultCross-Linking ReagentsPhotosensitizing AgentsRiboflavinCorneal cross-linkingKeratoconusRiboflavinTheranostics

Identifiers

PMID36587174
PMCPMC10313539
OpenAlexW4313379588

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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.