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. 2025 Dec 3.
doi: 10.1038/s41433-025-04102-8. Online ahead of print.

Impact of baseline visual acuity, time-in-range and early treatment on functional outcomes in DMO: insights from the IRISS outcomes

Igor Kozak  1 , Ramin Khoramnia  2   3 , Simon R Taylor  4 , Usha Chakravarthy  5 ; ILUVIEN Registry Safety Study (IRISS) Investigators Group
Collaborators, Affiliations

Impact of baseline visual acuity, time-in-range and early treatment on functional outcomes in DMO: insights from the IRISS outcomes

Igor Kozak et al. Eye (Lond). .

Abstract

Background/objectives: The initial visual acuity (VA) prior to treatment initiation can significantly influence long-term visual outcomes. The current analysis aimed to examine change in VA by baseline vision categories and their effects on time spent within visual change categories in patients with diabetic macular oedema (DMO) who underwent treatment with the intravitreal fluocinolone acetonide (FAc) implant.

Subjects/methods: This was a post-hoc analysis of the IRISS-Registry Data. Time-in-range (TIR) was calculated based on three VA letter-score-thresholds: ≥70, ≥65, and ≥60 ETDRS letters after treatment initiation. TIR was stratified by baseline VA in three groups: 0-33, 34-68, and 69-100 letters. The primary outcome was the mean TIR for the ≥70 letters threshold (equivalent to 6/12 in Snellen).

Results: A total of 671 eyes from 542 patients were included. VA improved significantly in all VA swimlane groups, with 84.8%, 71.7%, and 60.0% of eyes in the 0-33, 34-68, and 69-100 baseline VA categories, respectively, showing maintained or improved VA at 36 months (p = 0.0367). The mean TIR for the ≥70 letter threshold was significantly longer in the 69-100 letters subgroup (892.7 ± 413.4 days) compared to the 34-68 (648.4 ± 366.4 days) and 0-33 (251.3 ± 175.9 days) subgroups (p < 0.0001). No significant differences in TIR were observed based on the duration of DMO or the number of previous anti-angiogenic injections.

Conclusions: Eyes with better initial VA maintained functionally better visual acuity for longer following FAc implant treatment. TIR emerged as a potentially clinically relevant endpoint for evaluating long-term treatment outcomes in DMO, offering a broader perspective than traditional VA measures.

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Conflict of interest statement

Competing interests: Dr Igor Kozak reports no conflict of interest. Dr Ramin Khoramnia resports grants from Chengdu Kanghong; grants, personal fees, and non-financial support from Alimera Sciences, Bayer, Novartis and Roche, personal fees and non-financial support from Allergan, Heidelberg Engineering, Outlook Therapeutics and Zeiss outside the submitted work. Ethics approval: This study involves human participants and was approved by UK Health and Social Care Research Ethics Committee 2 (14/NI/0002). Portugal Comissao de Etica para a Saude da AIBILI (N/A), Comissoes de Etica para a Saude Instituto de Retina de Lisboa (N/A), Comissao de Etica para a Investigacao Clinica (2014-EO-03), Comissoes de Etica para a Saude Hospital Vila Franca de Xira (N/A), Comissoes de Etica para a Saude Centro Hospitalar do Porto (2015.130; 117-DEFI/ 107-CES), Comissoes de Etica para a Saude Centro Hospitalar de Leiria (N/A), Comissoes de Etica para a Saude Centro Hospitalar de Setubal (0015/2016F), Comissoes de Etica para a Saude Centro Hospitalar de Lisboa Ocidental, Entidades Publicas Empresarial (N/A), Comissao de Etica da Unidade de Saude Local Matosinhos (36/CE/JAS). Germany Ethikkommission Landesӓrztekammer Rheinland-Pfalz (837.501.13; 9186-F), Ethikkommission Universitӓts Klinikum Tubingen (088/2014BO2), Ethikkommission Rheinische Friedrich-Wilhelms- Universitӓt (044/14), Ethikkommission der Arztekammer Hamburg (N/A), Ethik kommission Universitӓt Leipzig (N/A), Ethikkommission Universitӓt Dusseldorf (4585), Ethikkommission der Arztekammer Berlin (N/A), Ethikkommission Heidelberg (S-058/ 2014). Participants gave informed consent to participate in the study before taking part. Patient consent for publication: Consent obtained directly from patient(s).

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