An observational study in Myopia and Astigmatism, sponsored by Ziemer Ophthalmic Systems AG. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Ziemer Ophthalmic Systems AG · Observational
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 173 observational studies indexed under Myopia.
Browse Myopia studies →Ziemer Ophthalmic Systems AG is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult subjects (clients of the ophthalmology clinic) enrolled in several European countries, scheduled to undergo refractive surgery to correct myopia AND/OR astigmatic myopia.
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.
Adult subjects suffering from myopia AND/OR astigmatism treated with CLEAR.
Device: CLEAR
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months post surgery
Refractive target [D]
Expressed as MRSE
Time frame: Preoperative assessment
Corrected distance visual accuity (CDVA)
Values expressed as per Snellen Chart lines
Time frame: 1 day post surgery
Corrected distance visual accuity (CDVA)
Values expressed as per Snellen Chart lines
Time frame: 1 month post surgery
Corrected distance visual accuity (CDVA)
Values expressed as per Snellen Chart lines
Time frame: 3 months post surgery
Corrected distance visual accuity (CDVA)
Values expressed as per Snellen Chart lines
Time frame: 6 months post surgery
Corrected distance visual accuity (CDVA)
Values expressed as per Snellen Chart lines
Time frame: 12 months post surgery
Refraction [SphD, CylD, Axis]
Examination of both subjective and objective refraction. Values may be expressed as MRSE.
Time frame: 1 day post surgery
Refraction [SphD, CylD, Axis]
Examination of both subjective and objective refraction. Values may be expressed as MRSE.
Time frame: 1 month post surgery
Refraction [SphD, CylD, Axis]
Examination of both subjective and objective refraction. Values may be expressed as MRSE.
Time frame: 3 months post surgery
Refraction [SphD, CylD, Axis]
Examination of both subjective and objective refraction. Values may be expressed as MRSE.
Time frame: 6 months post surgery
Refraction [SphD, CylD, Axis]
Examination of both subjective and objective refraction. Values may be expressed as MRSE.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 months
Assessment of changes in corneal pachymetry [um]
Following parameters will be assessed: * Central corneal thickness \[µm\] * Thinnest corneal point \[µm\]
Time frame: Baseline and 1 month
Assessment of changes in corneal pachymetry [um]
Following parameters will be assessed: * Central corneal thickness \[µm\] * Thinnest corneal point \[µm\]
Time frame: Baseline and 3 months
Assessment of changes in corneal pachymetry [um]
Following parameters will be assessed: * Central corneal thickness \[µm\] * Thinnest corneal point \[µm\]
Time frame: Baseline and 6 months
Assessment of changes in corneal pachymetry [um]
Following parameters will be assessed: * Central corneal thickness \[µm\] * Thinnest corneal point \[µm\]
Time frame: Baseline and 12 months
Assessment of changes in "white to white" [mm]
Time frame: Baseline and 1 month
Assessment of changes in "white to white" [mm]
Time frame: Baseline and 3 months
Assessment of changes in "white to white" [mm]
Time frame: Baseline and 6 months
Assessment of changes in "white to white" [mm]
Time frame: 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)
Time frame: Up to 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Ziemer Ophthalmic Systems AG