Myopia, Astigmatism
Conditions
Keywords
CLEAR, Ziemer, FEMTO LDV, Astigmatism, Myopia, Lenticule extraction
Brief summary
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.
Interventions
DEVICECLEAR
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
Sponsors
Ziemer Ophthalmic Systems AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better | 1 day post surgery | Uncorrected Distance Visual Accuity assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corrected distance visual accuity (CDVA) | 1 day post surgery | Values expressed as per Snellen Chart lines |
| Refraction [SphD, CylD, Axis] | 1 day post surgery | Examination of both subjective and objective refraction. Values may be expressed as MRSE. |
| Assessment of changes in corneal topography [um] | Baseline and 1 month | Following parameters will be assessed: * Simulated Keratometry (SimK) values * Average SimK (SimKavg) * Flat SimK (SimKf) * Steep SimK (SimKs) * Astigmatism \[D, °\] * Corneal anterior surface eccentricity |
| Refractive target [D] | Preoperative assessment | Expressed as MRSE |
| Assessment of changes in white to white [mm] | Baseline and 1 month | — |
| Number of Adverse Events observed in the study | Up to 12 months | Following events will be recorded: * Adverse device effects (ADEs) * Surgical complications (intraoperative and post-operative) |
| Assessment of changes in corneal pachymetry [um] | Baseline and 1 month | Following parameters will be assessed: * Central corneal thickness \[µm\] * Thinnest corneal point \[µm\] |
Outcome results
None listed