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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLEAR | Adult subjects suffering from myopia AND/OR astigmatism treated with CLEAR. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLEAR | Device | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive target [D] | Expressed as MRSE | Preoperative assessment |
| Corrected distance visual accuity (CDVA) | Values expressed as per Snellen Chart lines |
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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:
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.
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Adult subjects (clients of the ophthalmology clinic) enrolled in several European countries, scheduled to undergo refractive surgery to correct myopia AND/OR astigmatic myopia.
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 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:
| Baseline and 1 month |
| Assessment of changes in corneal topography [um] | Following parameters will be assessed:
| Baseline and 3 months |
| Assessment of changes in corneal topography [um] | Following parameters will be assessed:
| Baseline and 6 months |
| Assessment of changes in corneal topography [um] | Following parameters will be assessed:
| Baseline and 12 months |
| Assessment of changes in corneal pachymetry [um] | Following parameters will be assessed:
| Baseline and 1 month |
| Assessment of changes in corneal pachymetry [um] | Following parameters will be assessed:
| Baseline and 3 months |
| Assessment of changes in corneal pachymetry [um] | Following parameters will be assessed:
| Baseline and 6 months |
| Assessment of changes in corneal pachymetry [um] | Following parameters will be assessed:
| 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:
| Up to 12 months |