Evidence map›Paper›PMID 30242062›Full record

Observational studyThe British journal of ophthalmology2019

Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries.

Usha Chakravarthy, Simon R Taylor, Frank H Johannes Koch, João Paulo Castro de Sousa, Clare Bailey, ILUVIEN Registry Safety Study (IRISS) Investigators Group

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in The British journal of ophthalmology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01998412 (An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator), which is not on this map. Cited by 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
8.9field-weighted citation impact, top 2% 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.

NCT01998412 unknown statusnot on this map

An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator

Typeobservational_patient_registrySponsorAlimera SciencesRan2013 to 2020Enrolled559ConditionsChronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Intravitreal steroids for macular edema in diabetes.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Article
  4. Observational
  5. Article
  6. Article
  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. Article
  9. Review
  10. Article
  11. Article
  12. Observational
  13. Incidence and treatment approach of intraocular pressure elevation after various types of local steroids for retinal diseases.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2023
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Intravitreal Fluocinolone Acetonide Implant (ILUVIENDrug design, development and therapy · 2023
    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

6 authors at 5 institutions in 3 countries.

Usha ChakravarthyCentre for Public Health, Queen's University Belfast, Belfast, United Kingdom u.chakravarthy@qub.ac.uk.
Simon R TaylorOphthalmology Department, Royal Surrey County Hospital, Guildford, UK.
Frank H Johannes KochClinic of Ophthalmology, Goethe University, Frankfurt am Main, Germany.
João Paulo Castro de SousaOphthalmology Department, Leiria Hospital Center, Leiria, Portugal.
Clare BaileyBristol Eye Hospital, Bristol, UK.
ILUVIEN Registry Safety Study (IRISS) Investigators Group
Bristol Eye Hospital · GBGoethe University Frankfurt · DEInstituto Politécnico de Leiria · PTQueen's University Belfast · GBRoyal Surrey County Hospital · GB

Funding

Department of Health CDF-2011-04-051
6 · The paper itself

Abstract

aimsThe ILUVIEN Registry Safety Study is an ongoing, multicentre, open-label, observational study collecting real-world data on the safety and effectiveness of the 0.2 µg/day fluocinolone acetonide (FAc) implant in patients treated according to the European label requirements.

methodsPatients included in this analysis were treated for the licensed indication of chronic diabetic macular oedema (cDMO; that is, DMO that persists or recurs despite treatment). Data presented in the current analysis were collected from patient records up to 6 March 2017. Visual acuity (VA) data, including mean change in VA over time and at last observation, intraocular pressure (IOP) over the course of the study, IOP events, use of IOP-lowering therapy and cup:disc ratio were analysed. Information on additional DMO treatments post-FAc implant was also captured.

resultsFive hundred and sixty-three patients (593 eyes) were enrolled on the study. Mean IOP for the overall population remained within the normal range throughout follow-up and 76.7% of patients did not require IOP-lowering therapy following treatment with the FAc implant. Sixty-nine per cent of eyes did not require additional DMO treatments. Mean VA in the overall population increased from 51.9 letters at baseline to 55.6 letters at month 12, with a significant increase of 2.9 letters at last observation. Patients with short-term cDMO experienced greater VA gains than those with long-term cDMO.

conclusionsThe results of this analysis are comparable with those of other studies, including the Fluocinolone Acetate for Macular Edema study. The study reinforces the good safety and effectiveness profile of FAc, and demonstrates the benefit of early FAc treatment.

Indexed as

Visual AcuityAgedDiabetic RetinopathyDrug ImplantsEuropeFemaleFluocinolone AcetonideFollow-Up StudiesGlucocorticoidsHumansIntraocular PressureIntravitreal InjectionsMacular EdemaMaleMiddle AgedRetrospective StudiesDrug ImplantsFluocinolone AcetonideGlucocorticoidsclinical trialmaculapharmacologyretina

Identifiers

PMID30242062
PMCPMC6678053
OpenAlexW2891244783

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.