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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT00781092
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be a suitable candidate for FDA Approved LASIK.
* Subjects must have a stable refraction as documented by previous clinical records.
* Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery.
* Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery.
* Subjects must be at least 18 years of age.
* Subjects must be willing and able to return for scheduled follow up examinations each day after surgery at the specified time.
* Subjects must sign and be given a copy of the written Informed Consent form.
Exclusion Criteria:
* Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
* Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
* Subjects with clinically significant anterior segment pathology, including clinically significant cataracts, corneal scarring or neovascularization in either eye.
* Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
* Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
* Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or uncontrolled diabetes.
* Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP\>25 mm Hg in either eye.
* Subjects with macular pathology in either eye.
* Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
* Subjects with known sensitivity to planned study concomitant medications.
* Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
* Use of ocular drugs, other than study medications, during the study and within 30 days prior to study entry or any other ocular medication.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00781092
Study Brief:
Protocol Section:
NCT00781092