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:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT01556893
Eligibility Criteria:
Inclusion Criteria:
1. Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
2. Must be over 18 years of age
3. Must have visual acuity correctable to at least 20/25 in both eyes
4. If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses)
5. Must be willing and able to return for scheduled follow up examinations through 3 months after surgery
6. Must sign and be given a copy of the written Informed Consent form
7. Postoperative refractive target is emmetropia
Exclusion Criteria:
1. Known sensitivity to planned study concomitant medications
2. Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
3. Presenting any contraindications to femtosecond initiated LASIK
4. Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
5. Irregular astigmatism, based on Investigator's judgment
6. Undergoing monovision LASIK
7. Pregnant, lactating or plan to become pregnant during the course of this study
8. For bilateral second study eyes only: The surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01556893
Study Brief:
Protocol Section:
NCT01556893