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

Not Applicable

• Conditions: Epiretinal Membrane
• Interventions: Procedure: vitrectomy combined with intravitreal dexamethasone implant

• Registration Number: NCT06232616
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

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

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-28
• Study First Posted: 2024-01-31
• Status Verified: 2024-03
• Study Start: 2024-03-11
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	vitrectomy combined with intravitreal dexamethasone implant	In this single-arm designed study, participants with idiopathic epiretinal membranes with macular oedema were assigned a vitrectomy with an intravitreal dexamethasone implant.

Primary Outcome Measures

Name	Time	Method
improvement of visual acuity	from baseline to postoperative 24 weeks	mean change in best corrected visual acuity

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention & Treatment Center; 🇨🇳 Shanghai, Shanghai, China