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

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 24, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 31, 2024 to Nov 30, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v3
  2. Trial status: Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Feb 1, 2024 to Mar 11, 2024
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06232616
Lead Sponsor Shanghai Eye Disease Prevention and Treatment Center
Conditions
(from sponsor)		 Epiretinal Membrane
Related terms Epiretinal Membrane
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov