Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections

Overview

Intravitreal injections with dexamethasone implant (Ozurdex®) provide a reasonable and long-lasting treatment option in the cases of diabetic macular edema, as well as macular edema resulting from retinal vein occlusion and noninfectious posterior uveitis. During the course of these diseases, both eyes may be affected and may need therapy. The treatment burden associated with frequent medical visits associated with treatments in both eyes and follow-ups can be significant for patients and caregivers alike. Same-session bilateral ophthalmic procedures have proven safe and cost-effective, with patients consistently expressing a strong preference for this approach, particularly in the cases of cataract surgery and anti-VEGF injections when given the choice. The safety profile of same-day bilateral dexamethasone injections aligns with those of unilateral injections. This patient preference study will focus on addressing the practical aspects of same-day bilateral dexamethasone injections from the patients' perspective and aims to explore the impact of personal and socio-economic variables, and the overall perspective of patients on choosing same-day bilateral dexamethasone injections. Understanding and mitigating the challenges patients face can lead to a more patient-friendly and resource-saving approach. Based on the outcomes of this study, considerations may be made to introduce bilateral injections at our department, potentially optimizing patient experience and clinical resources. The aim of the study is to establish patient preferences regarding the administration of intravitreal dexamethasone implant injections in both eyes on the same day, in the same session and to identify key motivating and limiting factors from the patients' perspective.

Interventions

• Drug Ozurdex (dexamethasone)
  Intravitreal dexamethasone implant (Ozurdex) given according to the recommendations by the manufacturer.

Primary outcome measures

• Preference to bilateral injections [Time frame: Through study completion, an average of 9 months]

Secondary outcome measures (3)

• Reasons [Time frame: Through study completion, an average of 9 months]
• Differences in patient characteristics [Time frame: Through study completion, an average of 9 months]
• Differences in socio-economic variables between preference groups [Time frame: Through study completion, an average of 9 months]

Eligibility criteria

Inclusion criteria

• Having received at least one intravitreal dexamethasone implant in either eye
• >18 years of age
• Capacity to comprehend and answer questions in Danish language
• Signed informed consent

Exclusion criteria

• No intravitreal dexamethasone implant received within the last 12 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Denmark · 1 center

• Department of Ophthalmology, Rigshospitalet — Glostrup Municipality

Publications

• Bridges JFP, de Bekker-Grob EW, Hauber B, Heidenreich S, Janssen E, Bast A, Hanmer J, Danyliv A, Low E, Bouvy JC, Marshall DA. A Roadmap for Increasing the Usefulness and Impact of Patient-Preference Studies in Decision Making in Health: A Good Practices Report of an ISPOR Task Force. Value Health. 2023 Feb;26(2):153-162. doi: 10.1016/j.jval.2022.12.004. PMID 36754539
• Lin TC, Tseng PC, Hsu TK, Huang HW, Huang YM, Lo WJ, Chao CY, Chung YC. Same-Day Bilateral Intravitreal Dexamethasone Implants for the Treatment of Diabetic Macular Edema. Ophthalmologica. 2023;246(3-4):238-244. doi: 10.1159/000532056. Epub 2023 Aug 8. PMID 37552956
• Kapoor KG, Colchao JB. SAFETY OF CONSECUTIVE SAME-DAY BILATERAL INTRAVITREAL DEXAMETHASONE IMPLANT (OZURDEX). Retin Cases Brief Rep. 2020 Spring;14(2):200-202. doi: 10.1097/ICB.0000000000000653. PMID 29155696
• Dinh RH, Moushmoush O, Kolyvas P, Jacobsen BA, Mathai M, Sanghavi K, Levinson JD, Do BK. Describing Adverse Events Associated with Bilateral Same-Day Intravitreal Dexamethasone Implants. Ophthalmic Surg Lasers Imaging Retina. 2022 Nov;53(11):612-618. doi: 10.3928/23258160-20221018-04. Epub 2022 Nov 1. PMID 36378615
• Malcolm J, Leak C, Day AC, Baker H, Buchan JC. Immediate sequential bilateral cataract surgery: patient perceptions and preferences. Eye (Lond). 2023 May;37(7):1509-1514. doi: 10.1038/s41433-022-02171-7. Epub 2022 Jul 20. PMID 35859120
• Mahajan VB, Elkins KA, Russell SR, Boldt HC, Gehrs KM, Weingeist TA, Stone EM, Abramoff MD, Liu D, Folk JC. Bilateral intravitreal injection of antivascular endothelial growth factor therapy. Retina. 2011 Jan;31(1):31-5. doi: 10.1097/IAE.0b013e3181ed8c80. PMID 21187731
• Dickman MM, Spekreijse LS, Winkens B, Schouten JS, Simons RW, Dirksen CD, Nuijts RM. Immediate sequential bilateral surgery versus delayed sequential bilateral surgery for cataracts. Cochrane Database Syst Rev. 2022 Apr 25;4(4):CD013270. doi: 10.1002/14651858.CD013270.pub2. PMID 35467755
• Sav A, King MA, Whitty JA, Kendall E, McMillan SS, Kelly F, Hunter B, Wheeler AJ. Burden of treatment for chronic illness: a concept analysis and review of the literature. Health Expect. 2015 Jun;18(3):312-24. doi: 10.1111/hex.12046. Epub 2013 Jan 31. PMID 23363080

Identifiers

NCT: NCT06894017 · p-2024-16883

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗