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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT04549935
Eligibility Criteria:
Inclusion Criteria:
* Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
* 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 22 or above the age of 75
* Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
* Patients with active infectious ocular or extraocular disease.
* Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
* Paitents with know hypersensitivity to Dexamethasone
* Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
* Patients with a history of ocular inflammation or macular edema
* Patients with allergy or inability to receive intracameral antibiotic
* Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
* Patient with a corticosteriod implant (i.e. Ozurdex).
* Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
75 Years
Study:
NCT04549935
Study Brief:
Protocol Section:
NCT04549935