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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT01059006
Eligibility Criteria:
Inclusion Criteria:
* Male or female, of any race, and at least 35 to 80 years old with significant presbyopic symptoms at the time of the preoperative examination, and have signed an informed consent. The lower age limit of 35 is the earliest age in which reduction in accommodation occurs.
* Refractive error between +3.00 to -5.00 diopters (D) sphere at the spectacle plane with no more than 3.00D of refractive astigmatism (negative cylinder format)
* Best spectacle corrected visual acuity of at least 20/20 and J3 in both eyes.
* Residual corneal bed thickness of ≥ to 330 microns
* Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination.
* Soft contact lens users must have removed their lenses at least one week before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements and have two central keratometry readings and two manifest refractions taken at least one week apart that do not differ by more than 0.50 diopter in either meridian; mires should be regular.
* Located in the greater San Diego area for a 6-month period.
* Exhibit strong motivation for attending the follow-up visits.
* Access to transportation to meet follow-up requirements.
Exclusion Criteria:
* Patients that have previously been treated for refractive surgery (LASIK and/or PRK)
* Patients with known history or have concurrent dry eye disease (e.g. keratoconjunctivitis sicca)
* Patients who have less than 5 mm pupil size in dimlight
* Female subjects who are pregnant, breast-feeding or intend to become pregnant during the first six months of the study.
* Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatriptan (Imitrex) or any other triptan.
* Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
* Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or lens opacity.
* Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
* Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
* Corneal thickness insufficient to allow the residual remaining stromal bed to be at least 300 microns in each eye. The residual stromal bed thickness will be determined by subtracting both the LASIK flap thickness and depth of the ablation from the total central corneal thickness measured by pachymetry
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT01059006
Study Brief:
Protocol Section:
NCT01059006