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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00765960
Eligibility Criteria:
Inclusion Criteria:Subjects MUST fulfill the following conditions to qualify for enrollment into the trial Both eyes must have a manifest refractive error from -0.50 D to -6.00 D, a cylinder component up to -3.00 D, and a maximum manifest spherical equivalent of -6.00 D.
21 years of age or older at the time of the pre-operative examination. Both eyes must have a BSCVA of 20/20 or better; Both eyes must have a minimum pupil size of at least 6.0mm in dim illumination on wavescan.
Both eyes must demonstrate refractive stability confirmed by clinical records or previous glasses. Refractive stability shall be documented by a change of less than or equal to 0.50 diopter (sphere and cylinder) at an exam at least 12 months prior to the baseline examination. The astigmatic axis must also be within 15 degrees for eyes with cylinder greater than 0.50 D.
Willing and able to comply with scheduled visits and other study procedures.
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Exclusion Criteria:Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment. Also, the use of topical or systemic corticosteroids, whether chronic or acute Subjects with a history of any of the following medical conditions, or any other condition that could affect wound healing: uncontrolled diabetes, collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
Subject must not have a history of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization \> 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), or with evidence of glaucoma or propensity for narrow angle glaucoma in either eye.
The subject must not have any evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
Patients who do not achieve Iris registration at the time of their wavescan. Patients seeking monovision Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00765960
Study Brief:
Protocol Section:
NCT00765960