Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients of the Capital Region of Denmark who are treated at Rigshospitalet.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ozurdex (dexamethasone)
DrugIntravitreal dexamethasone implant (Ozurdex) given according to the recommendations by the manufacturer.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Preference to bilateral injections
Proportion of patients preferring and not preferring same-day bilateral dexamethasone implant injections
Time frame
Through study completion, an average of 9 monthsSecondary outcomes
1
Reasons
For preferring or not preferring same-day bilateral injections from the patient's perspective
Time frame
Through study completion, an average of 9 months2
Differences in patient characteristics
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
Time frame
Through study completion, an average of 9 months3
Differences in socio-economic variables between preference groups
As in: Need for caregivers, Means of transportation, Transport distance, Active vs retired, Highest education level
Time frame
Through study completion, an average of 9 monthsSponsors and contacts
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Source ClinicalTrials.gov