Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections

Recruiting

• Conditions: Informed Consent; Preference, Patient

• Registration Number: NCT06894017
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-13
• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-23
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-07
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Ophthalmology, Rigshospitalet; 🇩🇰 Glostrup, Denmark