Evidence map›Paper›PMID 35840291›Full record

ArticleThe British journal of ophthalmology2023

Safety and effectiveness of the fluocinolone acetonide intravitreal implant (ILUVIEN): 3-year results from the European IRISS registry study.

Ramin Khoramnia, Tunde Peto, Frank Koch, Simon R Taylor, João Paulo Castro de Sousa, Lauren Hill, Clare Bailey, Usha Chakravarthy, ILUVIEN Registry Safety Study (IRISS) Investigators Group

Open access · hybridAbstract read
In one paragraph

Article in The British journal of ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.7field-weighted citation impact, top 10% 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

14 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Intravitreal Fluocinolone Acetonide Implant for Diabetic Macular Edema: 2-Year Results from IDEAL, a Prospective German Observational Study.Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde · 2026
    Observational
  7. Radiation-induced maculopathy and fluocinolone acetonide implant.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Observational
  8. Review
  9. Article
  10. Review
  11. Review
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  14. Observational
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

9 authors at 6 institutions in 3 countries.

Ramin KhoramniaInternational Vision Correction Research Centre, Department of Ophthalmology, University Hospital Heidelberg, Heidelberg, Germany.ORCID 0000-0002-6237-7773
Tunde PetoCentre for Public Health, Blackwell's Queen's University, Belfast, UK.ORCID 0000-0001-6265-0381
Frank KochDepartment of Ophthalmology, Section of Vitreo-Retinal Surgery, Hospital of the Goethe University, Frankfurt am Main, Germany.
Simon R TaylorDepartment of Ophthalmology, University of Surrey, Guildford, UK.
João Paulo Castro de SousaOphthalmology Department, Leiria Hospital Centre, Pousos, Portugal.
Lauren HillConsultant, Bozeman, Montana, USA.
Clare BaileyBristol Eye Hospital, Bristol, UK.
Usha ChakravarthyQueen's University Belfast, Belfast, UK u.chakravarthy@qub.ac.uk.ORCID 0000-0002-2606-3734
ILUVIEN Registry Safety Study (IRISS) Investigators Group
Queen's University Belfast · GBBristol Eye Hospital · GBGoethe University Frankfurt · DEHeidelberg University · DEInstituto Politécnico de Leiria · PTUniversity of Surrey · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe ILUVIEN Registry Safety Study was a multicentre, open-label, non-randomised, observational, phase 4 study designed to assess the safety and effectiveness of the fluocinolone acetonide (FAc) implant in all indications in real-world practices in Europe.

methodsThe study included data collected prospectively and retrospectively. Patients receiving FAc implants between 2013 and 2017 were included and monitored until the last patient reached ≥3 years of follow-up. Mean intraocular pressure (IOP) data over the course of the study, along with IOP events, use of IOP-lowering therapy, mean change in visual acuity (VA) and information on supplemental therapy use were analysed post-FAc implantation.

resultsSix hundred and ninety-five eyes from 556 patients, with a mean±SD follow-up of 1150.5±357.36 days, were treated with a FAc implant. 96.7% of eyes had chronic diabetic macular oedema (cDMO). IOP lowering was achieved in 34.5% of eyes using topical agents and 4.3% by surgery. Seventy-three eyes (64.6% of 113 phakic) required cataract surgery during follow-up. Mean VA increased from a baseline of 52.2 letters to 57.1 letters at month 36, with improvement observed up to month 48. Supplementary therapies were given in 43.7% of eyes. When classified by length of cDMO less than or greater than the median duration those with a shorter history experienced greater VA gains than those with a longer history.

conclusionThis study confirms the favourable, long-term benefit-to-risk profile of the FAc implant in eyes with cDMO, with an additional benefit in patients when this therapy is administered earlier.

Indexed as

Diabetic RetinopathyMacular EdemaDrug ImplantsFluocinolone AcetonideGlucocorticoidsHumansIntravitreal InjectionsIrisRetrospective StudiesDrug ImplantsFluocinolone AcetonideGlucocorticoidsinflammationintraocular pressuremaculatreatment medicalvision

Identifiers

PMID35840291
PMCPMC10579189
OpenAlexW4285493333

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.