NCT06894017 Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections
| NCT ID | NCT06894017 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital, Rigshospitalet |
| Condition | Informed Consent |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-01-13 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Miklos Schneider, MD, PhD
PRINCIPAL INVESTIGATOR
Copenhagen University Hospital, Rigshospitalet
Frequently Asked Questions
Who can join the NCT06894017 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Informed Consent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06894017 currently recruiting?
Yes, NCT06894017 is actively recruiting participants. Contact the research team at lena.michelle.moerup.andersen@regionh.dk for enrollment information.
Where is the NCT06894017 trial being conducted?
This trial is being conducted at Glostrup Municipality, Denmark.
Who is sponsoring the NCT06894017 clinical trial?
NCT06894017 is sponsored by Copenhagen University Hospital, Rigshospitalet. The principal investigator is Miklos Schneider, MD, PhD at Copenhagen University Hospital, Rigshospitalet. The trial plans to enroll 200 participants.