Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01701518
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic epiretinal membrane.
* Central retinal thickness ≥ 250 μm.
* Age more than 18 years old.
* Decision makers able to give informed consent.
* Females of child bearing potential must agree to use acceptable means of birth control for the duration of the study.
Exclusion Criteria:
* Secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.).
* Any other macular pathology that could affect anatomic or functional results.
* History of uveitis requiring intravitreal triamcinolone injection.
* History of steroid-responsive glaucoma.
* History of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7).
* IOP \> 23 mm Hg if untreated, or \> 21 mm Hg if treated with medication.
* Pregnant or breast-feeding woman.
* Unable to attend the scheduled follow-up appointments.
* Patients with known hypersensitivity to any components of Ozurdex® or to other corticosteroids.
* Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01701518
Study Brief:
Protocol Section:
NCT01701518