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

Launched by SHANGHAI EYE DISEASE PREVENTION AND TREATMENT CENTER · Jan 28, 2024

Keywords

ClinConnect Summary

This study is testing whether adding a dexamethasone implant to a planned eye surgery helps people with idiopathic epiretinal membrane (a thin scar on the retina) and swelling in the central retina (cystoid macular edema). All participants will have the same treatment: a three-port vitrectomy with peeling of the membrane, plus cataract surgery if needed, and at the end of the operation they will receive a dexamethasone implant in the eye. The trial will look at whether vision improves and how the central retina thickens or shrinks over 24 weeks after surgery, along with changes in the swollen area and eye pressure.

Who can join: adults 40 years and older who have symptomatic idiopathic epiretinal membrane with macular edema, defined by a central retinal thickness greater than 300 micrometers and swelling near the central vision (fovea). They must also have an axial length under 25 mm. People with other major eye diseases, prior retina surgery or injections, glaucoma or optic nerve disease, or certain uncontrolled health issues or certain eye medications are not eligible. The study is in Shanghai, China, at the Shanghai Eye Disease Prevention and Treatment Center, and is currently enrolling about 20 participants. Results will be shared after publication, and de-identified study data may be available by request after results are published.

Gender

ALL

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.