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 range22 Years
SexALL
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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.
✓. 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.
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
✕. 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.