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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT03789669
Eligibility Criteria:
INCLUSION CRITERIA
To be considered for enrollment of the study, subject must:
* Sign an informed consent and HIPAA authorization
* Be at least 18 years of age at the time of study exam
* Have refractive error and be eligible for commercial LASIK treatment
* Be available for all scheduled follow-up visits (see below)
EXCLUSION CRITERIA
Subject will not be eligible to take part of the study if subject, use or have:
* Known to be pregnant, breastfeeding or intend to become pregnant during the study.
* Recent ocular (eye) trauma or eye surgery
* A history of or active ophthalmic (eye) disease or abnormality
* Ocular hypertension (high eye pressure) with IOP (eye pressure) greater than 21 mmHg, glaucoma suspect, or are taking medications for these conditions
* A history or current diagnosis of any of the following medical conditions that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency disease, ocular herpes; endocrine disorders including, but not limited to unstable thyroid disorders and diabetes, lupus, and rheumatoid arthritis.
* Cardiac pacemaker, implanted defibrillator or other implanted electronic device
* Taking systemic or inhaled medications that may affect wound healing
* Known sensitivity or inappropriate responsiveness to any of the medications used in the study
* Desire for monovision correction
* Participating in any other clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03789669
Study Brief:
Protocol Section:
NCT03789669