CLEAR Procedure in Myopia and Astigmatism - Registry Study

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre, Prospective, Registry Study for Femtosecond Laser Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) Procedure in Myopia and Astigmatism

Conditions
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Myopia, Astigmatism

Intervention / Treatment
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* Device: CLEAR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLEAR<br>Adult subjects suffering from myopia AND/OR astigmatism treated with CLEAR. | Device: CLEAR<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better | Uncorrected Distance Visual Accuity assessment | 1 day post surgery | 
| The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better | Uncorrected Distance Visual Accuity assessment | 1 month post surgery | 
| The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better | Uncorrected Distance Visual Accuity assessment | 3 months post surgery | 
| The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better | Uncorrected Distance Visual Accuity assessment | 6 months post surgery | 
| The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better | Uncorrected Distance Visual Accuity assessment | 12 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive target [D] | Expressed as MRSE | Preoperative assessment | 
| Corrected distance visual accuity (CDVA) | Values expressed as per Snellen Chart lines | 1 day post surgery | 
| Corrected distance visual accuity (CDVA) | Values expressed as per Snellen Chart lines | 1 month post surgery | 
| Corrected distance visual accuity (CDVA) | Values expressed as per Snellen Chart lines | 3 months post surgery | 
| Corrected distance visual accuity (CDVA) | Values expressed as per Snellen Chart lines | 6 months post surgery | 
| Corrected distance visual accuity (CDVA) | Values expressed as per Snellen Chart lines | 12 months post surgery | 
| Refraction [SphD, CylD, Axis] | Examination of both subjective and objective refraction. Values may be expressed as MRSE. | 1 day post surgery | 
| Refraction [SphD, CylD, Axis] | Examination of both subjective and objective refraction. Values may be expressed as MRSE. | 1 month post surgery | 
| Refraction [SphD, CylD, Axis] | Examination of both subjective and objective refraction. Values may be expressed as MRSE. | 3 months post surgery | 
| Refraction [SphD, CylD, Axis] | Examination of both subjective and objective refraction. Values may be expressed as MRSE. | 6 months post surgery | 
| Refraction [SphD, CylD, Axis] | Examination of both subjective and objective refraction. Values may be expressed as MRSE. | 12 months post surgery | 
| Assessment of changes in corneal topography [um] | Following parameters will be assessed: Simulated Keratometry (SimK) values Average SimK (SimKavg) Flat SimK (SimKf) Steep SimK (SimKs) Astigmatism [D, °] Corneal anterior surface eccentricity | Baseline and 1 month | 
| Assessment of changes in corneal topography [um] | Following parameters will be assessed: Simulated Keratometry (SimK) values Average SimK (SimKavg) Flat SimK (SimKf) Steep SimK (SimKs) Astigmatism [D, °] Corneal anterior surface eccentricity | Baseline and 3 months | 
| Assessment of changes in corneal topography [um] | Following parameters will be assessed: Simulated Keratometry (SimK) values Average SimK (SimKavg) Flat SimK (SimKf) Steep SimK (SimKs) Astigmatism [D, °] Corneal anterior surface eccentricity | Baseline and 6 months | 
| Assessment of changes in corneal topography [um] | Following parameters will be assessed: Simulated Keratometry (SimK) values Average SimK (SimKavg) Flat SimK (SimKf) Steep SimK (SimKs) Astigmatism [D, °] Corneal anterior surface eccentricity | Baseline and 12 months | 
| Assessment of changes in corneal pachymetry [um] | Following parameters will be assessed: Central corneal thickness [µm] Thinnest corneal point [µm] | Baseline and 1 month | 
| Assessment of changes in corneal pachymetry [um] | Following parameters will be assessed: Central corneal thickness [µm] Thinnest corneal point [µm] | Baseline and 3 months | 
| Assessment of changes in corneal pachymetry [um] | Following parameters will be assessed: Central corneal thickness [µm] Thinnest corneal point [µm] | Baseline and 6 months | 
| Assessment of changes in corneal pachymetry [um] | Following parameters will be assessed: Central corneal thickness [µm] Thinnest corneal point [µm] | Baseline and 12 months | 
| Assessment of changes in white to white [mm] |  | Baseline and 1 month | 
| Assessment of changes in white to white [mm] |  | Baseline and 3 months | 
| Assessment of changes in white to white [mm] |  | Baseline and 6 months | 
| Assessment of changes in white to white [mm] |  | Baseline and 12 months | 
| Number of Adverse Events observed in the study | Following events will be recorded: Adverse device effects (ADEs) Surgical complications (intraoperative and post-operative) | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLEAR, Ziemer, FEMTO LDV, Astigmatism, Myopia, Lenticule extraction