MyopiaAQUARIUZ2020NCT04794023
LASIK Surgery With a New Laser for the Treatment of Myopia Without Astigmatism
A study testing Corneal Ablation in people with Myopia and Astigmatism, run by Ziemer Ophthalmic Systems AG at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Corneal Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Mar 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria number 3 to 6, 10, 11 and 12 only apply to eyes planned for investigational treatment. Inclusion criterion number 9 applies to both eyes whether planned for investigational treatment or not and inclusion criterion number 8 applies to each eye as specified in the criteria.
- Informed Consent as documented by signature
- Medically suitable for corneal refractive surgery
- Stable refraction over a minimum of 12 months prior to surgery Stable refraction is defined as MRSE change per year in the eye to be treated ≤ 0.50 D and should be confirmed by at least one measurement between 1 and 10 years previous to the study.
- Myopia sphere from -0.5 D to -4.0 D
- Phases I \& II: Maximum cylinder diopter -1.5 D
Show all 25Show fewer
- Phase II \& III: Maximum cylinder diopter -1.0 D
- Accurate baseline biometric measurements Accurate baseline biometric measurements are defined as
- Assessed Manifest Refraction within ± 0.5 D of Objective Refraction
- Less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions
- Objective refraction should be assessed by
- Autorefractometer And either/or
- Hartmann-Shack Aberrometer
- Ray tracing Aberrometer
- Age ≥ 18 years
- Calculated residual stroma thickness ≥ 300 microns
- IOP, as measured by non-contact tonometry < 21mmHg
- Phase I: One of the following
- Amblyopic eye An amblyopic eye is defined as an eye that has decreased functional visual acuity due to an insufficient development in the visual system according to the judgement of the investigator, and the following criteria
- Pre-operative CDVA up to 20/32 ( 0.63 in decimal convention)
- Pre operative CDVA in the fellow, dominant eye ≥ 20/40 (0.5 in decimal convention)
- Post-cataract patient, and the following criteria
- Pre-operative CDVA in each eye ≥ 20/40 (0.5 in decimal convention)
- Phase II \& III: Pre-operative CDVA in each eye ≥ 20/40 (0.5 in decimal convention)
- Patient willing and able to return to the study site for the follow-up visits, in the judgement of the investigator
Who cannot join
- The following exclusion criteria apply for both eyes, whether planned for treatment or not.
- Severe local infective or allergic conditions (e.g. blepharitis, past herpes simplex or zoster, allergic eye disease severe enough to require regular treatment).
- Corneal disease or pathology, such as but not limited to corneal scarring or opacity, history of viral keratitis, dry eye, recurrent epithelial erosion and Fuchs' endothelial dystrophy
- Manifest or subclinical keratoconus or keratectasia, as diagnosed by corneal topography and/or anterior optical coherence tomography
- Patients with degeneration of structures of the cornea, diagnosed keratoconus or any clinical pictures suggestive to keratoconus (form-fruste keratoconus)
- Corneal thickness < 480 microns
Show all 26Show fewer
- Previous corneal surgery of any kind, including surgery for either refractive or therapeutic purposes in either eye that, in the judgement of the investigator confounds the outcome of the study or increases risk for the patient
- Glaucoma and/or ocular hypertension, whether untreated and under medical control
- Nystagmus or hemifacial spasm
- Known allergy to medications used in surgery, pre- and post-operative treatment at the investigational site
- Immunocompromised or diagnosis of ophthalmic disease (any of the following):
- ocular herpes zoster or simplex
- lupus
- collagenases
- other acute or chronic illnesses that increases the risk to the participant or confounds the outcomes of this study in the opinion of the investigator
- Patients with a diagnosed collagen vascular, atopic syndrome, autoimmune or immunodeficiency disease
- Known psychotic disorders associated with delusions (e.g. schizophrenia)
- Drug or alcohol abuse
- Neurological diagnosis with a GCS > 13
- Women who are pregnant or nursing or who plan to become pregnant over the course of this investigation.
- Inability to follow the procedures of the study in the opinion of the investigator, e.g. due to language problems, psychological disorders, dementia, etc.
- Participation in another interventional study within the 30 days preceding and during the present study
- Patients with uncontrolled diabetes
- Patients who are taking one or both of the following medications:
- Isotretinoin (e.g. Accutane®)
- Amiodarone hydrochloride (e.g. Cordarone®)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Augen Glattzentrum ONO Wallisellen
Wallisellen, Canton Zürich, CH-8304
Valéry V Wittwer, Dr. med., +41795285375, v.wittwer@icloud.com
Valéry V Wittwer, Dr. med.
About this study
Official title: A Combined First In Man And Pilot Study Investigating Visual And Refractive Outcomes In Lasik Surgery Using The Aquariuz Ablation Laser In Patients With Myopia, With Or Without Astigmatism
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.
Read more
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.
- Conditions
- Myopia, Astigmatism
- Being tested
- Corneal Ablation
- Keywords
- femtosecond LASIK, Solid state laser, AQUARIUZ, Corneal ablation
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal AblationDevice
Corneal ablation for the treatment of myopia with/without astigmatism following flap creation using femtosecond laser.
| Study group | Role | What they receive |
|---|---|---|
| Intervention_Corneal Ablation | Experimental | Not described Receives: Device: Corneal Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change 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
Measured: 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
Measured: 3 months
Number of Serious Adverse Events
SAEs related to the device or the procedure under investigation
Measured: 3 months
Secondary outcomes (31)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 12 months
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 1 week post surgery.
Measured: Baseline and 1 week
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 1 month post surgery.
Measured: Baseline and 1 month
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 3 months post surgery.
Measured: Baseline and 3 months
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 6 months post surgery.
Measured: Baseline and 6 months
Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 12 months post surgery.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start31 Mar 2021
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I * Successful unilateral treatment of the dominant eye according to standard of care prior to investigational treatment * Unilateral investigational treatment on an amblyopic eye or a post-cataract eye * 4 eyes \& 4 participants * Staged patient enrolment, to allow assessment and evaluation of safety parameters before investigational treatment is applied to the next participant * Interim analysis I - Verification of correction factor when all participants have reached 7 days follow-up Phase II * Initiated after Interim analysis I * Successful unilateral treatment of the dominant eye according to standard of care prior to investigational treatment * Unilateral investigational treatment on the non-dominant eye * 10 eyes \& 10 participants * Interim analysis II - Confirmation of correction factor when all participants have reached 7 days follow-up Phase III * Initiated after Interim analysis II * Bilateral investigational treatment * 26 eyes \& 13 participants
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziemer Ophthalmic Systems AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794023
- Sponsor's protocol ID
- ZS004
- Acronym
- AQUARIUZ2020
- Status last verified
- Apr 2021
- First submitted
- 4 Mar 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined First In Man And Pilot Study Investigating Visual And Refractive Outcomes In Lasik Surgery Using The Aquariuz Ablation Laser In Patients With Myopia, With Or Without Astigmatism
- ClinicalTrials.gov ID
- NCT04794023
- Acronym / sponsor ID
- AQUARIUZ2020 / ZS004
- Conditions
- Myopia, Astigmatism
- Keywords
- femtosecond LASIK, Solid state laser, AQUARIUZ, Corneal ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Ziemer Ophthalmic Systems AGIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I * Successful unilateral treatment of the dominant eye according to standard of care prior to investigational treatment * Unilateral investigational treatment on an amblyopic eye or a post-cataract eye * 4 eyes \& 4 participants * Staged patient enrolment, to allow assessment and evaluation of safety parameters before investigational treatment is applied to the next participant * Interim analysis I - Verification of correction factor when all participants have reached 7 days follow-up Phase II * Initiated after Interim analysis I * Successful unilateral treatment of the dominant eye according to standard of care prior to investigational treatment * Unilateral investigational treatment on the non-dominant eye * 10 eyes \& 10 participants * Interim analysis II - Confirmation of correction factor when all participants have reached 7 days follow-up Phase III * Initiated after Interim analysis II * Bilateral investigational treatment * 26 eyes \& 13 participants
| Arm | Type | Receives |
|---|---|---|
| Intervention_Corneal Ablation | Experimental | Device: Corneal Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Inclusion criteria number 3 to 6, 10, 11 and 12 only apply to eyes planned for investigational treatment. Inclusion criterion number 9 applies to both eyes whether planned for investigational treatment or not and inclusion criterion number 8 applies to each eye as specified in the criteria.
Key exclusion criteria (26 listed)
- The following exclusion criteria apply for both eyes, whether planned for treatment or not.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal AblationCorneal ablation for the treatment of myopia with/without astigmatism following flap creation using femtosecond laser. | Device | Intervention_Corneal Ablation |
Primary outcome
Change between pre-operative CDVA and CDVA at 3 months follow-up
Time frame: Baseline and 3 months
Change between pre-operative CDVA and CDVA at 3 months follow-up: > 1 line loss from pre-operative CDVA
Number of unexpected Adverse Events
Time frame: 3 months
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
Number of Serious Adverse Events
Time frame: 3 months
SAEs related to the device or the procedure under investigation
31 secondary outcomes
Change between pre-operative CDVA and post-operative UDVA
Time frame: Baseline and 1-day
Change between pre-operative CDVA and post-operative UDVA
Time frame: Baseline and 1 week
Change between pre-operative CDVA and post-operative UDVA
Time frame: Baseline and 1 month
Change between pre-operative CDVA and post-operative UDVA
Time frame: Baseline and 3 months
Change between pre-operative CDVA and post-operative UDVA
Time frame: Baseline and 6 months
Change between pre-operative CDVA and post-operative UDVA
Time frame: Baseline and 12 months
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 1 week post surgery.
Time frame: Baseline and 1 week
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 1 month post surgery.
Time frame: Baseline and 1 month
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 3 months post surgery.
Time frame: Baseline and 3 months
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 6 months post surgery.
Time frame: Baseline and 6 months
Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 12 months post surgery.
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.
Time frame: Baseline and 1 week
Observed difference in manifest refraction after 1 month post surgery.
Time frame: Baseline and 1 month
Observed difference in manifest refraction after 3 months post surgery.
Time frame: Baseline and 3 months
Observed difference in manifest refraction after 6 months post surgery.
Time frame: Baseline and 6 months
Observed difference in manifest refraction after 12 months post surgery.
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.
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.
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.
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.
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.
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal Ablation in people with Myopia and Astigmatism, run by Ziemer Ophthalmic Systems AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valéry V Wittwer, Dr. med. (+41 79 528 53 75, v.wittwer@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between pre-operative CDVA and CDVA at 3 months follow-up (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.