Evaluation of the Effectiveness of Treatment With Dexamethasone Intravitreal Implant in Cystoid Macular Edema Secondary to Retinal Vein Occlusion
Overview
- Phase
- Not Applicable
- Intervention
- Intravitreal injection
- Conditions
- Macular Edema, Cystoid
- Sponsor
- Università degli Studi dell'Insubria
- Enrollment
- 30
- Primary Endpoint
- Visual acuity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Purpose: To evaluate retinal functional improvement by means of visual acuity and retinal sensibility examination after intravitreal dexamethasone implant in patients affected by cystoid macular edema secondary to retinal vein occlusion.
Detailed Description
Cystoid macular edema represents the most important cause of visual impairment after retinal vein occlusion. The etiological factors of this complication are under investigation, from inflammatory cytokines to the breakdown of vascular barrier with increased permeability and diffusion of angiogenic factors. Clinical research developed different drugs and therapeutic strategies to treat and control macular edema, to evaluate the correct timetable and to reach long-term clinical significative results. At now, different experiences have been published with available drugs, from steroids to anti Vascular Endothelial Growth Factor. A debate still remains about the correct approach, the correct combination of drugs (if necessary) and the correct evaluation of drug effectiveness. In our study, we will evaluate extensive functional recovery and its relation to macular thickness after steroid injection. Considering that visual acuity reflects only foveal function, it may not be sufficient to evaluate the overall function on the macular area. We introduce microperimetry study as a valuable and reproducible tool to create a functional mapping of the entire macula.
Investigators
Simone Donati
Study Investigator
Università degli Studi dell'Insubria
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Macular Edema Patients
Patients affected by cystoid macular edema (CME) due to retinal vein occlusion of recent onset (less than three months) will be enrolled.
Intervention: Intravitreal injection
Outcomes
Primary Outcomes
Visual acuity
Time Frame: 6 months
evaluation of visual acuity
retinal sensibility
Time Frame: 6 months
microperimetry evaluation