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

March 11, 2024 updated by: Shanghai Eye Disease Prevention and Treatment Center

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Shanghai Eye Disease Prevention & Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Procedure: vitrectomy combined with intravitreal dexamethasone implant
The dexamethasone implant will be injected into the vitreous cavity at the end of the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of visual acuity
Time Frame: from baseline to postoperative 24 weeks
mean change in best corrected visual acuity
from baseline to postoperative 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Investigators

  • Study Chair: Tao Sun, Ph.D., Shanghai Eye Diseases Prevention & Treatment Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YFZXYDK202401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

mean change in best corrected visual acuity throughout the study until the results are published in the journal.

IPD Sharing Time Frame

after the results are published in the journal.

IPD Sharing Access Criteria

E-mail contact

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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