Evidence map›Paper›PMID 37414935›Full record

Observational studyEye (London, England)2024

Effectiveness and safety of XEN45 implant over 12 months of follow-up: data from the XEN-Glaucoma Treatment Registry.

Francesco Oddone, Gloria Roberti, Sara Giammaria, Chiara Posarelli, Giorgio Ghirelli, Leonardo Mastropasqua, Luca Agnifili, Tommaso Micelli Ferrari, Vincenzo Pace, Paolo Nucci and 11 more

Open access · hybridAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Eye (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
4.5field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 16 citations in OpenAlex.

  1. Factors influencing the long-term-success of the XEN gel stent.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  2. Article
  3. Observational
  4. Review
  5. Longitudinal analysis of XEN45 gel stent bleb morphology using bleb grading scales, anterior segment-OCT, in vivo confocal microscopy, and impression cytology.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. How to Rescue of the Dislocated XENJournal of current ophthalmology
    Article
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

21 authors at 9 institutions in 1 country.

Francesco OddoneIRCCS - Fondazione Bietti, Rome, Italy. odd1fr@gmail.com.ORCID 0000-0002-2504-0004
Gloria RobertiIRCCS - Fondazione Bietti, Rome, Italy.ORCID 0000-0001-8788-5785
Sara GiammariaIRCCS - Fondazione Bietti, Rome, Italy.
Chiara PosarelliDepartment of Surgical, Medical, Molecular Pathology and of Critical Care Medicine, University of Pisa, Pisa, Italy.
Giorgio GhirelliSan Pietro Fatebenefratelli Hospital, Rome, Italy.
Leonardo MastropasquaOphthalmology Clinic, Department of Medicine and Aging Science, University G. D'Annunzio of Chieti-Pescara, Chieti, Italy.
Luca AgnifiliOphthalmology Clinic, Department of Medicine and Aging Science, University G. D'Annunzio of Chieti-Pescara, Chieti, Italy.ORCID 0000-0002-1625-6305
Tommaso Micelli FerrariRegional General Hospital F. Miulli of Acquaviva delle Fonti, Bari, Italy.
Vincenzo PaceRegional General Hospital F. Miulli of Acquaviva delle Fonti, Bari, Italy.
Paolo NucciDepartment of Biomedical, Surgical, and Dental Sciences, University of Milan, Milan, Italy.
Matteo SacchiEye Clinic, San Giuseppe Hospital - IRCCS Multimedica, Milan, Italy.
Gianluca MonsellatoEye Clinic, San Giuseppe Hospital - IRCCS Multimedica, Milan, Italy.
Romeo AltafiniOphthalmology Clinic, Dolo Hospital, Venezia, Italy.
Gianluca ScuderiOphthalmology Unit, St. Andrea Hospital, NESMOS Department, University of Rome "Sapienza", Rome, Italy.
Andrea PerdicchiOphthalmology Unit, St. Andrea Hospital, NESMOS Department, University of Rome "Sapienza", Rome, Italy.
Maurizio UvaUniversity Hospital "Policlinico Vittorio Emanuele", Catania, Italy.ORCID 0000-0001-6422-3711
Carmela CarnevaleIRCCS - Fondazione Bietti, Rome, Italy.
Giuseppe CovelloDepartment of Surgical, Medical, Molecular Pathology and of Critical Care Medicine, University of Pisa, Pisa, Italy.
Maria Novella MaglionicoDepartment of Surgical, Medical, Molecular Pathology and of Critical Care Medicine, University of Pisa, Pisa, Italy.
Antonio FeaStruttura Complessa Oculistica, Città Della Salute e Della Scienza di Torino, Dipartimento di Scienze Chirurgiche-Università Degli Studi di Torino, 10126, Torino, Italy.ORCID 0000-0002-6551-6054
Michele FigusDepartment of Surgical, Medical, Molecular Pathology and of Critical Care Medicine, University of Pisa, Pisa, Italy.
Fondazione G.B. Bietti · ITUniversity of Pisa · ITMultiMedica · ITOspedale Generale Regionale Francesco Miulli · ITUniversity of Chieti-Pescara · ITAzienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele · ITFatebenefratelli Hospital · ITUniversity of Milan · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the 1-year effectiveness and safety of the XEN45, either alone or in combination with phacoemulsification, in glaucoma patients.

methodsThis multicentre, prospective, observational study included consecutive eyes of glaucoma patients from the Italian XEN-Glaucoma Treatment Registry (XEN-GTR) who underwent XEN45 alone or in combination with phacoemulsification, with at least 1 year of follow-up. Surgical success was defined as intraocular pressure (IOP) < 18 mmHg and ≥20% reduction from preoperative IOP, over 1 year of follow-up.

resultsTwo hundred thirty-nine eyes (239 patients) were analyzed, 144 (60.2%) eyes in the XEN-solo and 95 (39.8%) eyes in the XEN+Phaco groups. One hundred-sixty-eight (70.3%) eyes achieved overall success, without statistically significant differences between study groups (p = 0.07). Preoperative IOP dropped from a median (IQR) of 23.0 (20.0-26.0) mmHg to 14.0 (12.0-16.0) mmHg at month 12 (p < 0.001), with overall 39.9 ± 18.3% IOP reduction. The mean number of preoperative ocular hypotensive medications (OHM) was significantly reduced from 2.7 ± 0.9 to 0.5 ± 0.9 at month 12 (p < 0.001). Preoperative IOP < 15 mmHg (HR: 6.63; 95%CI: 2.61-16.84, p < 0.001) and temporal position of the surgeon (HR: 4.25; 95%CI: 2.62-6.88, p < 0.001) were significantly associated with surgery failure. One hundred-forty-six (61.1%) eyes had no intraoperative complications, whereas 91 (38.1%) and 56 (23.4%) eyes experienced at least one complication, respectively early (< month 1) and late (≥ month 1), all self-limiting or successfully treated without sequelae. Needling occurred in 55 (23.0%) eyes at least once during follow-up.

conclusionOver 1-year follow-up, XEN45 alone or in combination with phacoemulsification, had comparable success rates and effectively and safely lowered IOP and the need for OHM.

Indexed as

GlaucomaGlaucoma Drainage ImplantsGlaucoma, Open-AngleHumansIntraocular PressureProspective StudiesRetrospective StudiesStentsTreatment Outcome

Identifiers

PMID37414935
PMCPMC10764778
OpenAlexW4383466259

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.