A PHASED, PROSPECTIVE, MULTI-CENTER STUDY OF THE ELITA SYSTEM (NCT05713253) | Clinical Trial Compass
TerminatedNot Applicable
A PHASED, PROSPECTIVE, MULTI-CENTER STUDY OF THE ELITA SYSTEM
Stopped: Business decision - not related to safety or device performance
United States96 participantsStarted 2023-02-02
Plain-language summary
This study will be a 2-phase, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation to confirm the safety and effectiveness of the ELITA system.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥22 years old.
. Subjects with myopic refractive error up to -10.00 D sphere and astigmatism up to -5.00 D with the sum of sphere and cylinder between -1.00 D and -10.00 D using minus cylinder convention based on manifest refraction.
. Anticipated residual corneal stromal thickness of at least 250 microns based on preoperative corneal pachymetry minus calculated maximum lenticule thickness to be extracted.
. Uncorrected visual acuity of 20/40 or worse.
. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Monocular UCVA
Timeframe: 6 months or at the point of refractive stability
2
Maintenance of BSCVA
Timeframe: 6 months or at the point of refractive stability
. Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
. A stable refractive error (based on a previous exam, medical records, lensometry, or prescription at least 12 months prior to the preoperative manifest refraction), as defined by a change of ≤0.50 D in MRSE and ≤0.50 D in MRC. Additionally, the astigmatic axis must also be within 15 degrees for eyes with \>0.50 D of preoperative and historical manifest cylinder.
Exclusion criteria
. 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.
. 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.
. History of prior intraocular or corneal surgery (including cataract extraction and/or refractive surgery), existing corneal implant, active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, history or evidence of corneal ulcer (including but not limited to presence of visible corneal scar, abnormal topography is NOT necessary), clinically significant dry eye disease, neovascularization \> 1 mm from limbus, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma/lesions, corneal opacity within the central 9 mm and visible on topography.
. Evidence of glaucoma regardless of medication regimen or control, an IOP greater than 21 mmHg at screening or propensity for narrow angle glaucoma.
. Evidence of keratoconus, pellucid marginal degeneration, corneal dystrophy or irregularity, unstable (distorted/not clear) corneal mires on central keratometry images, corneal edema, corneal lesion, hypotony, or abnormal topography. Corneal thickness thinner than 490 microns at the thinnest point.
. Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.
. Either eye does not meet all inclusion criteria and does not fall within approved indications for treatment using femtosecond or excimer Laser.