Clinical trial NCT06894017: Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections
Official title: Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Informed Consent
Preference, Patient
Keywords: Intravitreal
dexamethasone
injections
implant
questionnaire
patient preference
bilateral
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Capital Region of Denmark who are treated at Rigshospitalet.

Brief summary: 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.


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

Primary outcomes:
measure: Preference to bilateral injections
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
measure: Reasons
timeFrame: Through study completion, an average of 9 months
measure: Differences in patient characteristics
timeFrame: Through study completion, an average of 9 months
measure: Differences in socio-economic variables between preference groups
timeFrame: Through study completion, an average of 9 months
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Miklos Schneider, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: European Medicines Agency. Ozurdex. Accessed 21/11/2023, https://www.ema.europa.eu/en/medicines/human/EPAR/ozurdex