Clinical trial NCT05484531: CLEAR Procedure in Myopia and Astigmatism - Registry Study
Official title: A Multicentre, Prospective, Registry Study for Femtosecond Laser Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) Procedure in Myopia and Astigmatism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Astigmatism
Keywords: CLEAR
Ziemer
FEMTO LDV
Astigmatism
Myopia
Lenticule extraction
Lead sponsor: Ziemer Ophthalmic Systems AG
Sponsor class: INDUSTRY
First posted: 2022-08-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects (clients of the ophthalmology clinic) enrolled in several European countries, scheduled to undergo refractive surgery to correct myopia AND/OR astigmatic myopia.

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.


Eligibility 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.

Primary outcomes:
measure: The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better
timeFrame: 1 day post surgery
measure: The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better
timeFrame: 1 month post surgery
measure: The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better
timeFrame: 3 months post surgery
measure: The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better
timeFrame: 6 months post surgery
measure: The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better
timeFrame: 12 months post surgery
Secondary outcomes:
measure: Refractive target [D]
timeFrame: Preoperative assessment
measure: Corrected distance visual accuity (CDVA)
timeFrame: 1 day post surgery
measure: Corrected distance visual accuity (CDVA)
timeFrame: 1 month post surgery
measure: Corrected distance visual accuity (CDVA)
timeFrame: 3 months post surgery
measure: Corrected distance visual accuity (CDVA)
timeFrame: 6 months post surgery
measure: Corrected distance visual accuity (CDVA)
timeFrame: 12 months post surgery
measure: Refraction [SphD, CylD, Axis]
timeFrame: 1 day post surgery
measure: Refraction [SphD, CylD, Axis]
timeFrame: 1 month post surgery
measure: Refraction [SphD, CylD, Axis]
timeFrame: 3 months post surgery
measure: Refraction [SphD, CylD, Axis]
timeFrame: 6 months post surgery
measure: Refraction [SphD, CylD, Axis]
timeFrame: 12 months post surgery
measure: Assessment of changes in corneal topography [um]
timeFrame: Baseline and 1 month
measure: Assessment of changes in corneal topography [um]
timeFrame: Baseline and 3 months
measure: Assessment of changes in corneal topography [um]
timeFrame: Baseline and 6 months
measure: Assessment of changes in corneal topography [um]
timeFrame: Baseline and 12 months
measure: Assessment of changes in corneal pachymetry [um]
timeFrame: Baseline and 1 month
measure: Assessment of changes in corneal pachymetry [um]
timeFrame: Baseline and 3 months
measure: Assessment of changes in corneal pachymetry [um]
timeFrame: Baseline and 6 months
measure: Assessment of changes in corneal pachymetry [um]
timeFrame: Baseline and 12 months
measure: Assessment of changes in "white to white" [mm]
timeFrame: Baseline and 1 month
measure: Assessment of changes in "white to white" [mm]
timeFrame: Baseline and 3 months
measure: Assessment of changes in "white to white" [mm]
timeFrame: Baseline and 6 months
measure: Assessment of changes in "white to white" [mm]
timeFrame: Baseline and 12 months
measure: Number of Adverse Events observed in the study
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
References: