Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane With Macular Oedema
- Conditions
- Epiretinal Membrane
- Registration Number
- NCT06232616
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- symptomatic patients aged 40 years or above with idiopathic stage 3-4 epiretinal membrane defined on the basis of spectral-domain optical coherence tomography classification;
- central retinal thickness >300 µm;
- cystoid oedema within a 1 mm diameter range with the macular fovea as the center;
- ocular axial length less than 25.00 mm.
- concomitant or previous macular diseases that may hinder visual improvement other than epiretinal membrane (e.g., age-associated macular degeneration, retinal vein occlusion, or diabetic macular oedema);
- previous vitreoretinal surgery or intravitreal injection history;
- history of glaucoma or optic neuropathy of any kind;
- patients with uncontrolled systemic diseases or infectious diseases;
- patients who took medicines that may have ocular side effects, such as glucocorticoid or hydroxychloroquine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method improvement of visual acuity from baseline to postoperative 24 weeks mean change in best corrected visual acuity
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Shanghai Eye Disease Prevention & Treatment Center
🇨🇳Shanghai, Shanghai, China
Shanghai Eye Disease Prevention & Treatment Center🇨🇳Shanghai, Shanghai, China