Informed Consent, Preference, Patient
Conditions
Keywords
Intravitreal, dexamethasone, injections, implant, questionnaire, patient preference, bilateral
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.
Interventions
Intravitreal dexamethasone implant (Ozurdex) given according to the recommendations by the manufacturer.
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preference to bilateral injections | Through study completion, an average of 9 months | Proportion of patients preferring and not preferring same-day bilateral dexamethasone implant injections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons | Through study completion, an average of 9 months | For preferring or not preferring same-day bilateral injections from the patient's perspective |
| Differences in patient characteristics | Through study completion, an average of 9 months | Between preference groups in: Age, Sex, Previous injection count, Indication for intravitreal treatment (medical diagnosis), Complications of previous treatments, Ocular comorbidity (e.g. glaucoma, cataract, previous retinal detachment etc.), Systemic comorbidity |
| Differences in socio-economic variables between preference groups | Through study completion, an average of 9 months | As in: Need for caregivers, Means of transportation, Transport distance, Active vs retired, Highest education level |
Countries
Denmark
Contacts
Primary ContactLena Michelle Mørup Andersen, MScN
Outcome results
None listed