CLEAR Procedure in Myopia and Astigmatism - Registry Study

Ziemer Ophthalmic Systems AG150 enrolled

Overview

Multicenter, prospective, single-arm, observational, non-interventional post market clinical investigation (registry study) with the overall objective to assess safety and performance of CLEAR in a real world setting.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Myopia Astigmatism

Interventions

CLEARDEVICE

Reduction or elimination of myopia from -0.50 D to -10.00 D, with astigmatism of 0 D to -5.00 D or without astigmatism, and MRSE of -0.50 D to -12.50 D in the eye to be treated in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Formal inclusion/exclusion criteria are not applicable to the study at hand, due to its observational and non-interventional nature. Patients treated with the CLEAR application using FEMTO LDV Z8, enrolled in the study are expected not to present with any of the market-approved device's contraindications: * Residual thickness of stromal bed that is less than 250 microns from the corneal endothelium * Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration * Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) * Irregular or unstable (distorted/not clear) corneal mires on central keratometry images * Severe dry eye * Active eye infection or inflammation * Recent herpes eye infection or problems resulting from past infection * Active autoimmune disease or connective tissue disease * Uncontrolled diabetes * High IOP fluctuations that are not controlled under medications and continuous visual field damage Note 1: The above listed contraindications are a subject to change, as per PMS, risk management or other regulatory feedback, and will be covered and communicated to the participating investigators in the prospective updates of the Operator's Manual. Note 2: Only eyes of patients treated bilaterally shall be included in the analysis covered by this registry study. Note 3: Patient's targeted for "monovision" shall not be included in the analysis covered by this registry study. Note 4: Clinical cases, that despite presenting any of the above listed contraindications, would still be enrolled in the study by the Investigator, may be subject to a sub-group statistical analysis.