Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: The Cheetah system & CHEETAH Patient Interface: For each subject, surgeons will create an iLEX refractive correction using the Cheetah system (investigational Cheetah femtosecond laser
Sponsors
Johnson Johnson Surgical Vision Inc
Eligibility
Inclusion criteria
Inclusion criteria: All criteria apply to each Cheetah treated eye -Age =18 years old at the time of consenting. - Partially sighted eyes. BSCVA and pin-hole acuity of the iLEX treated eye is worse than 20/50, with at least a 2-line difference between the iLEX treated eye and the fellow eye. - Anticipated residual corneal stromal thickness of at least 250 microns based on preoperative corneal pachymetry minus maximum lenticule thickness to be extracted. - 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 =1.00 D in MRSE. Additionally, the astigmatic axis must also be within 15 degrees for eyes with >0.50 D of preoperative and historical manifest cylinder. - Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability according to the following: - Rigid contact lenses (toric or spherical) must be removed for at least 4 weeks and soft contact lenses (toric or spherical) for at least 2 weeks prior to the first refraction used to establish stability. - Two consecutive manifest refractions and keratometry readings must be conducted at least 7 days apart. - Refractive stability is defined as a change of not more than 0.50 D in manifest refractive sphere and cylinder as well as keratometry meridian (either axis) between measurements. - If the subject/eye meets the refractive stability criteria, contact lens wear is not permitted prior to surgery - Willing and capable of complying with follow-up examinations for the duration of the study. - Signed informed consent or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment.
Exclusion criteria
Exclusion criteria: All criteria apply to each eye - 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. NOTE: The use of inhaled or systemic corticosteroids, whether chronic or acute, is deemed to adversely affect healing and subjects using such medications are specifically excluded from eligibility. - 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), lupus, and rheumatoid arthritis. - Subjects with history of Diabetes Mellitus of 12 years or more and HbA1c measurement greater than 7% within a month prior to treatment. - Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device. - History of prior corneal surgery (including cataract extraction), 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 syndrome, neovascularization > 1 mm from limbus), clinical evidence of trauma, 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. - Note: For phase I subjects (partially sighted eyes), history of intraocular surgery (including cataract extraction), retinal detachment/repair, and clinically significant lens opacity is acceptable for inclusion in the study. -Evidence of glaucoma regardless of medication regimen or control, an IOP greater than 21 mmHg at screening or propensity for narrow angle glaucoma. NOTE: Phase I subjects with end-stage glaucoma and completely extinguished visual field are eligible to participate in the study - 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 470 microns at the thinnest point - Women who are pregnant, breast-feeding, or intend to become pregnant during the study. - Participation in any other clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this clinical trial is to evaluate the safety and effectiveness of the Cheetah system for the correction of myopic refractive errors including evaluation of the ease of lenticule removal, refractive outcomes, visual outcomes and adverse events. PHASE I ENDPOINT Five consecutive cases with successful removal of complete lenticule without any in-situ fragmentation and lenticule diameter within 0.5 mm from intended (measured with a caliper post removal, op day)Timepoint: Operative day | — |
Secondary
| Measure | Time frame |
|---|---|
| Lenticule depth, Corneal flattening, Evaluation of induced irregular astigmatism, ease of lenticule removal, entry cut access adequacy to lenticule cavity, entry cut wound appearance, corneal clarity during lenticule creation (OBL), corneal clarity after procedure, grading of procedure workflowTimepoint: Op-day, 1-day, 1-week, 3 months | — |
Countries
India
Contacts
Public ContactDr Akshay Shah
Johnson and Johnson Surgical Vision
Outcome results
None listed