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

Epiretinal Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06232616
• Other study ID #: YFZXYDK202401
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epiretinal Membrane
• Macular Edema

Intervention

Procedure:
• vitrectomy combined with intravitreal dexamethasone implant
The dexamethasone implant will be injected into the vitreous cavity at the end of the surgery.

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention & Treatment Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of visual acuity	mean change in best corrected visual acuity	from baseline to postoperative 24 weeks