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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT01657266
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years who require cataract surgery
* Both genders
* Provide informed consent
* Normal Laboratory results
Exclusion Criteria:
* Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery
* Patients with any trans-surgical complication
* Patients with a cataract \>NC4, C4 or P4 classified with the system LOCS
* Patients with any active corneal pathology
* Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)
* Patients with IOP \<5 or \>21 mmHg
* Patients that have ocular pain, cellularity or flare at the moment of selection
* Patients with ocular exfoliation, trauma or any inflammatory disease
* Patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus
* Patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye
* Patients with history of hypersensitivity or contraindication for any drug used in the study
* Patients under anticoagulant treatment
* Contact lens users
* Pregnant patients, at risk of pregnancy or breastfeeding
* Patients without birth control treatment
* Patients with any active toxicomania (alcoholism, cigarette, cannabis or others)
* Patients who had participated in any clinical trial in the last 90 days
* Legal or mentally disabled patients who could not give informed consent
* Patients who cannot comply with all study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01657266
Study Brief:
Protocol Section:
NCT01657266