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:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05023304
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery.
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form
Exclusion Criteria:
* Patients under the age of 18.
* Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test).
* Active infectious ocular or systemic disease.
* Patients with active infectious ocular or extraocular disease.
* Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
* Patients with known hypersensitivity to Dexamethasone.
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
* Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C \> 10.0.
* Patients with a history of ocular inflammation or macular edema.
* Patients with a pre-existing epiretinal membrane (ERM)
* Patients with allergy or inability to receive intracameral antibiotic.
* Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL
* Patients with a corticosteroid implant (i.e. Ozurdex).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05023304
Study Brief:
Protocol Section:
NCT05023304