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

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.

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Key information

Conditions

Epiretinal Membrane Eye Diseases Retinal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vitrectomy combined with intravitreal dexamethasone implant

Procedure

The dexamethasone implant will be injected into the vitreous cavity at the end of the surgery.

Primary outcomes

improvement of visual acuity

Time frame: from baseline to postoperative 24 weeks

mean change in best corrected visual acuity

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

Vitrectomy Combined With Intravitreal Dexamethasone Implant for the Treatment of Idiopathic Epiretinal Membrane With Cystoid Macular Oedema

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jan 31, 2024
Registry last updated: Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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