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

NCT ID: NCT06232616

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2025-12-31

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.

Conditions

Epiretinal Membrane

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: OTHER

vitrectomy combined with intravitreal dexamethasone implant

Intervention Type: PROCEDURE

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

Interventions

vitrectomy combined with intravitreal dexamethasone implant

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Sun, Ph.D.

Role: STUDY_CHAIR

Shanghai Eye Diseases Prevention & Treatment Center

Locations

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

YFZXYDK202401

Identifier Type: -

Identifier Source: org_study_id