NCT04794023Unknown不适用
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
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change between pre-operative CDVA and CDVA at 3 months follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
- •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
- •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®)
结局指标
主要结局
Change between pre-operative CDVA and CDVA at 3 months follow-up
时间窗: 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 Serious Adverse Events
时间窗: 3 months
SAEs related to the device or the procedure under investigation
Number of unexpected Adverse Events
时间窗: 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
次要结局
- 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.(Baseline and 1 week)
- Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 3 months post surgery.(Baseline and 3 months)
- Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 1 week post surgery.(Baseline and 1 week)
- Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 1 month post surgery.(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.(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.(Baseline and 6 months)
- Change between pre-operative CDVA and post-operative UDVA(Baseline and 12 months)
- Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 3 months post surgery.(Baseline and 3 months)
- Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 12 months post surgery.(Baseline and 12 months)
- Observed difference in manifest refraction after 6 months post surgery.(Baseline and 6 months)
- Difference (in terms of cylindrical power and orientation of meridians) between pre-operative and post-operative magnitude of astigmatism after 1 month post surgery.(Baseline and 1 month)
- Difference (in terms of cylindrical power and orientation of meridians) between pre-operative and post-operative magnitude of astigmatism after 12 months post surgery.(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 12 months post surgery.(Baseline and 12 months)
- Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 1 week post surgery.(Baseline and 1 week)
- Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 1 month post surgery.(Baseline and 1 month)
- Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 6 months post surgery.(Baseline and 6 months)
- Difference between attempted versus achieved Manifest Refraction Spherical Equivalent (MRSE) after 12 months post surgery.(Baseline and 12 months)
- Percentage of eyes within ±0.5 D, and ±1 D of the attempted MRSE after 6 months post surgery.(Baseline and 6 months)
- Observed difference in manifest refraction after 1 month post surgery.(Baseline and 1 month)
- Observed difference in manifest refraction after 3 months post surgery.(Baseline and 3 months)
- Observed difference in manifest refraction after 12 months post surgery.(Baseline and 12 months)
- Observed difference in manifest refraction after 1 week post surgery.(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.(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 6 months post surgery.(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 1 week post surgery.(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 3 months post surgery.(Baseline and 3 months)
研究者
研究点 (2)
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