The AQUARIUZ ablation laser is a solid-state laser and has been CE approved for corneal surgery since March 2020 for the treatment of short- and longsightedness with and without astigmatism. The aim of this study is to collect the first clinical data. Safety and performance are examined here. The treatment with AQUARIUZ is comparable to treatments with an excimer laser, with the difference that these are operated with gas. Solid-state lasers and excimer lasers use the same process for tissue ablation, with a small difference in wavelength. This difference manifests itself in the lower involvement of water in the ablation process with the result of a gentler and safer treatment. Similar to excimer lasers for corneal surgery, the AQAURIUZ system (Ziemer Ophthalmic Systems AG) is equipped with a fast eye tracker (eye tracking system) to correct eye movements during the treatment. The shape of the removed portion of the cornea has an aspherical profile corresponding to the state of the art. The primary objective is to assess the safety of use of the AQUARIUZ corneal ablation laser for LASIK procedures in myopia and myopia with astigmatism. The secondary objective is to compare the predicted visual and refractive outcomes of LASIK procedures using the AQUARIUZ Ablation with clinical data. The study is planned in 3 phases to mitigate the inherent risk of a first in man study and to allow for verification and confirmation of the system correction factor at an early stage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Corneal ablation for the treatment of myopia with/without astigmatism following flap creation using femtosecond laser.
Augen Glattzentrum ONO Wallisellen
Wallisellen, Canton Zürich, Switzerland
RECRUITINGChange between pre-operative CDVA and CDVA at 3 months follow-up
Change between pre-operative CDVA and CDVA at 3 months follow-up: \> 1 line loss from pre-operative CDVA
Time frame: Baseline and 3 months
Number of unexpected Adverse Events
Unexpected adverse events (AEs) related to the device or the procedure under investigation, and that from the sponsor's or the principal investigator's point of view compromise patient safety
Time frame: 3 months
Number of Serious Adverse Events
SAEs related to the device or the procedure under investigation
Time frame: 3 months
Change between pre-operative CDVA and post-operative UDVA
The UDVA in decimal notation is defined as the inverse of the minimum angle of resolution (MAR) in a patients eye achieved without correction lenses or spectacles, measured over a distance of 4-6 metres by standardized letter charts . The CDVA is defined as the inverse of the minimum angle of resolution (MAR) in a patient's eye achieved with the best sphero-cylindrical prescription in trial lenses or spectacles, measured analogously to UDVA.
Time frame: Baseline and 1-day
Change between pre-operative CDVA and post-operative UDVA
The UDVA in decimal notation is defined as the inverse of the minimum angle of resolution (MAR) in a patients eye achieved without correction lenses or spectacles, measured over a distance of 4-6 metres by standardized letter charts . The CDVA is defined as the inverse of the minimum angle of resolution (MAR) in a patient's eye achieved with the best sphero-cylindrical prescription in trial lenses or spectacles, measured analogously to UDVA.
Time frame: Baseline and 1 week
Change between pre-operative CDVA and post-operative UDVA
The UDVA in decimal notation is defined as the inverse of the minimum angle of resolution (MAR) in a patients eye achieved without correction lenses or spectacles, measured over a distance of 4-6 metres by standardized letter charts . The CDVA is defined as the inverse of the minimum angle of resolution (MAR) in a patient's eye achieved with the best sphero-cylindrical prescription in trial lenses or spectacles, measured analogously to UDVA.
Time frame: Baseline and 1 month
Change between pre-operative CDVA and post-operative UDVA
The UDVA in decimal notation is defined as the inverse of the minimum angle of resolution (MAR) in a patients eye achieved without correction lenses or spectacles, measured over a distance of 4-6 metres by standardized letter charts . The CDVA is defined as the inverse of the minimum angle of resolution (MAR) in a patient's eye achieved with the best sphero-cylindrical prescription in trial lenses or spectacles, measured analogously to UDVA.
Time frame: Baseline and 3 months
Change between pre-operative CDVA and post-operative UDVA
The UDVA in decimal notation is defined as the inverse of the minimum angle of resolution (MAR) in a patients eye achieved without correction lenses or spectacles, measured over a distance of 4-6 metres by standardized letter charts . The CDVA is defined as the inverse of the minimum angle of resolution (MAR) in a patient's eye achieved with the best sphero-cylindrical prescription in trial lenses or spectacles, measured analogously to UDVA.
Time frame: Baseline and 6 months
Change between pre-operative CDVA and post-operative UDVA
The UDVA in decimal notation is defined as the inverse of the minimum angle of resolution (MAR) in a patients eye achieved without correction lenses or spectacles, measured over a distance of 4-6 metres by standardized letter charts . The CDVA is defined as the inverse of the minimum angle of resolution (MAR) in a patient's eye achieved with the best sphero-cylindrical prescription in trial lenses or spectacles, measured analogously to UDVA.
Time frame: Baseline and 12 months
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 1 week post surgery.
The MRSE is defined as the mean refractive deficit in diopters (D) over two main meridians as assessed by monocular sphero-cylindrical refraction (manifest refraction). The manifest refraction is a set of three numerical, continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees). MRSE is deduced from the manifest refraction as follows: MRSE = MRSPH + ½ x MRCYL
Time frame: Baseline and 1 week
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 1 month post surgery.
The MRSE is defined as the mean refractive deficit in diopters (D) over two main meridians as assessed by monocular sphero-cylindrical refraction (manifest refraction). The manifest refraction is a set of three numerical, continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees). MRSE is deduced from the manifest refraction as follows: MRSE = MRSPH + ½ x MRCYL
Time frame: Baseline and 1 month
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 3 months post surgery.
The MRSE is defined as the mean refractive deficit in diopters (D) over two main meridians as assessed by monocular sphero-cylindrical refraction (manifest refraction). The manifest refraction is a set of three numerical, continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees). MRSE is deduced from the manifest refraction as follows: MRSE = MRSPH + ½ x MRCYL
Time frame: Baseline and 3 months
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 6 months post surgery.
The MRSE is defined as the mean refractive deficit in diopters (D) over two main meridians as assessed by monocular sphero-cylindrical refraction (manifest refraction). The manifest refraction is a set of three numerical, continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees). MRSE is deduced from the manifest refraction as follows: MRSE = MRSPH + ½ x MRCYL
Time frame: Baseline and 6 months
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 12 months post surgery.
The MRSE is defined as the mean refractive deficit in diopters (D) over two main meridians as assessed by monocular sphero-cylindrical refraction (manifest refraction). The manifest refraction is a set of three numerical, continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees). MRSE is deduced from the manifest refraction as follows: MRSE = MRSPH + ½ x MRCYL
Time frame: Baseline and 12 months
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 1 week post surgery.
Time frame: Baseline and 1 week
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 1 month post surgery.
Time frame: Baseline and 1 month
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 3 months post surgery.
Time frame: Baseline and 3 months
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 6 months post surgery.
Time frame: Baseline and 6 months
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 12 months post surgery.
Time frame: Baseline and 12 months
Observed difference in manifest refraction after 1 week post surgery.
The manifest refraction is a set of three numerical continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees).
Time frame: Baseline and 1 week
Observed difference in manifest refraction after 1 month post surgery.
The manifest refraction is a set of three numerical continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees).
Time frame: Baseline and 1 month
Observed difference in manifest refraction after 3 months post surgery.
The manifest refraction is a set of three numerical continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees).
Time frame: Baseline and 3 months
Observed difference in manifest refraction after 6 months post surgery.
The manifest refraction is a set of three numerical continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees).
Time frame: Baseline and 6 months
Observed difference in manifest refraction after 12 months post surgery.
The manifest refraction is a set of three numerical continues variables (Spherical dioptres - MRSPH, cylindrical dioptres - MRCYL, cylindrical axis in degrees).
Time frame: Baseline and 12 months
Difference (in terms of cylindrical power and orientation of meridians) between Target Induced Astigmatism (TIA) versus Surgically Induced Astigmatism (SIA) after 1 week post surgery.
Time frame: Baseline and 1 week
Difference (in terms of cylindrical power and orientation of meridians) between pre-operative and post-operative magnitude of astigmatism after 1 month post surgery.
Time frame: Baseline and 1 month
Difference (in terms of cylindrical power and orientation of meridians) between pre-operative and post-operative magnitude of astigmatism after 3 months post surgery.
Time frame: Baseline and 3 months
Difference (in terms of cylindrical power and orientation of meridians) between pre-operative and post-operative magnitude of astigmatism after 6 months post surgery.
Time frame: Baseline and 6 months
Difference (in terms of cylindrical power and orientation of meridians) between pre-operative and post-operative magnitude of astigmatism after 12 months post surgery.
Time frame: Baseline and 12 months
Angle of error, defined as the angle described by the vectors of the achieved correction (SIA) versus the intended correction (TIA) after 1 week post surgery.
The angle of error is positive if the achieved correction is on an axis counterclockwise (CCW) to where it was intended and negative if the achieved correction is clockwise (CW) to its intended axis. The astigmatism vector is the combination of the magnitude, MRCYL, and the cylindrical axis in degrees and will be assessed as described above. Vector analysis will be performed according to Alpins et al 2001 and Thibos et al 2001.
Time frame: Baseline and 1 week
Angle of error, defined as the angle described by the vectors of the achieved correction (SIA) versus the intended correction (TIA) after 1 month post surgery.
The angle of error is positive if the achieved correction is on an axis counterclockwise (CCW) to where it was intended and negative if the achieved correction is clockwise (CW) to its intended axis. The astigmatism vector is the combination of the magnitude, MRCYL, and the cylindrical axis in degrees and will be assessed as described above. Vector analysis will be performed according to Alpins et al 2001 and Thibos et al 2001.
Time frame: Baseline and 1 month
Angle of error, defined as the angle described by the vectors of the achieved correction (SIA) versus the intended correction (TIA) after 3 months post surgery.
The angle of error is positive if the achieved correction is on an axis counterclockwise (CCW) to where it was intended and negative if the achieved correction is clockwise (CW) to its intended axis. The astigmatism vector is the combination of the magnitude, MRCYL, and the cylindrical axis in degrees and will be assessed as described above. Vector analysis will be performed according to Alpins et al 2001 and Thibos et al 2001.
Time frame: Baseline and 3 months
Angle of error, defined as the angle described by the vectors of the achieved correction (SIA) versus the intended correction (TIA) after 6 months post surgery.
The angle of error is positive if the achieved correction is on an axis counterclockwise (CCW) to where it was intended and negative if the achieved correction is clockwise (CW) to its intended axis. The astigmatism vector is the combination of the magnitude, MRCYL, and the cylindrical axis in degrees and will be assessed as described above. Vector analysis will be performed according to Alpins et al 2001 and Thibos et al 2001.
Time frame: Baseline and 6 months
Angle of error, defined as the angle described by the vectors of the achieved correction (SIA) versus the intended correction (TIA) after 12 months post surgery.
The angle of error is positive if the achieved correction is on an axis counterclockwise (CCW) to where it was intended and negative if the achieved correction is clockwise (CW) to its intended axis. The astigmatism vector is the combination of the magnitude, MRCYL, and the cylindrical axis in degrees and will be assessed as described above. Vector analysis will be performed according to Alpins et al 2001 and Thibos et al 2001.
Time frame: Baseline and 12 months
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