Health Condition 1: H522- Astigmatism Health Condition 2: H520- Hypermetropia Health Condition 3: H521- Myopia
Conditions
Interventions
Intervention1: ELITA SYSTEM and ELITA PATIENT INTERFACE: The Elita system is an ophthalmic laser surgical system that is developed for use in the creation of a corneal flap in patients undergoing LASI
Sponsors
Johnson Johnson Surgical Vision Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. A residual anticipated stromal bed thickness of at least 250 microns 2. Subjects with myopia or hyperopia with or without astigmatism (including mixed astigmatism) eligible for commercial LASIK treatment. 3. Pre-op distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better 4.Pre-op distance Uncorrected Visual Acuity (UCVA) of 20/32 or worse 5. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment. 6. Willing and capable of complying with follow-up examinations for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Concurrent use of systemic (including inhaled) 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. 2. History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis. Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device. 3. History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis/conjunctivitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma. 4. Evidence of keratoconus, corneal dystrophy or irregularity, corneal edema, corneal lesion, hypotony, or abnormal topography. 5. Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course. 6. A fellow eye that does not meet all inclusion criteria and does not fall within approved indications for treatment using excimer Laser. 7. Desire for monovision correction 8.Women who are pregnant, breast-feeding, or intend to become pregnant during the course of the study. 9. Participation in any other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the study is the ease of flap lift, as measured by the proportion of eyes where a clinically acceptable flap lift was created. Clinically acceptable flap lift is defined as a score of 0-2 on the ease of flap lift questionnaire item. Success criteria: the ease of flap lift should be graded 0-2 in at least 90% eyesTimepoint: Operative visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean MRSE will be summarized over time. The frequency counts and proportions of eyes within MRSE within Ã?±0.50 D and within Ã?±1.00 D will be reported.Timepoint: Preoperative visit and each available postoperative visit;Summary statistics for SPEED scores for each visit and SPEED score difference between pre-operative and 1-month postoperative visits will be reported.Timepoint: Preoperative visit and 1-month postoperative visits;The frequency count and proportion of eyes with each acuity line of UCVATimepoint: Preoperative visit and each available postoperative visit.;The frequency count and proportion of the response to the side cut quality questionnaire item, graded on a scale of 0-4.Timepoint: Operative Visit;The frequency count and proportion of the response to the stromal bed surface quality (surface smoothness) questionnaire item, graded on a scale of 0-4.Timepoint: Operative Visit;The frequency counts and proportions of acuity line change from preoperative to postoperative of BSCVATimepoint: Preoperative to postoperative;The frequency counts and proportions of eyes with medical findings/ complications/adverse events will be summarized.Timepoint: Preoperative to postoperative;The frequency counts and proportions of surgeon questionnaire for workflow of flap creation (docking, centration adjustments, suction during treatment, flap lift and edge quality) responses, graded on a scale of 0-4.Timepoint: Operative Visit;The frequency counts and proportions of the number of suction losses for both during docking (prior to pressing ââ?¬Ë?Lockââ?¬â?¢) and during treatment.Timepoint: Operative Visit | — |
Countries
Croatia, India
Contacts
Public ContactDr Akshay Shah
CENTRE FOR SIGHT EYE INSTITUTE
Outcome results
None listed