Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane With Macular Oedema

Sponsored by Shanghai Eye Disease Prevention and Treatment Center

About this trial

Last updated a year ago

Study ID

YFZXYDK202401

Status

Enrolling by invitation

Type

Interventional

Phase

N/A

Placebo

Accepting

40+ Years

All Sexes

Trial Timing

Ended 5 months ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.