Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane With Macular Oedema
NCT06232616 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-04-24
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of 25-gauge pars plana vitrectomy combined with intravitreal dexamethasone implant for the treatment of idiopathic epiretinal membrane with cystoid macular oedema. The main questions it aims to answer are:
* mean changes in best corrected visual acuity and central macular thickness from baseline to post-operative 24 weeks
* mean change in proportion of cystoid macular oedema area from baseline to post-operative 24 weeks
* intraocular pressure throughout postoperative 24 weeks
* concentrations of inflammatory factors in vitreous samples Participants will undergo a standard three-port 25-gauge pars plana vitrectomy and epiretinal membrane peeling combined with phacoemulsification, aspiration, and intraocular lens implantation. The dexamethasone implant will be injected into the vitreous cavity at the end of the operation.
Conditions
- Epiretinal Membrane
Interventions
- PROCEDURE
-
vitrectomy combined with intravitreal dexamethasone implant
The dexamethasone implant will be injected into the vitreous cavity at the end of the surgery.
Sponsors & Collaborators
-
Shanghai Eye Disease Prevention and Treatment Center
lead OTHER
Principal Investigators
-
Tao Sun, Ph.D. · Shanghai Eye Diseases Prevention & Treatment Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-11
- Primary Completion
- 2025-11-30
- Completion
- 2025-12-31
Countries
- China
Study Locations
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