Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane Wi… (NCT06232616) | Clinical Trial Compass
By InvitationNot Applicable
Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane With Macular Oedema
China20 participantsStarted 2024-03-11
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
improvement of visual acuity
Timeframe: from baseline to postoperative 24 weeks
Trial details
NCT IDNCT06232616
SponsorShanghai Eye Disease Prevention and Treatment Center