LASIK Surgery With a New Laser for the Treatment of Myopi... | NCT04794023

Description Module

Brief 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. 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.

Label	Type	Description	Intervention Names
Intervention_Corneal Ablation	Experimental		Device: Corneal Ablation

Name	Type	Description	Arm Group Labels	Other Names
Corneal Ablation	Device	Corneal ablation for the treatment of myopia with/without astigmatism following flap creation using femtosecond laser.	Intervention_Corneal Ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	3 months
Number of Serious Adverse Events	SAEs related to the device or the procedure under investigation	3 months

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Measure	Description	Time Frame
Change between pre-operative CDVA and CDVA after 1 week post surgery.		Baseline and 1 week
Change between pre-operative CDVA and CDVA after 1 month post surgery.		Baseline and 1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
1. Informed Consent as documented by signature
2. Medically suitable for corneal refractive surgery
3. 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.
4. Myopia sphere from -0.5 D to -4.0 D
5. Phases I & II: Maximum cylinder diopter -1.5 D
6. Phase II & III: Maximum cylinder diopter -1.0 D
7. 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
8. Age ≥ 18 years
9. Calculated residual stroma thickness ≥ 300 microns
10. IOP, as measured by non-contact tonometry < 21mmHg
11. 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)
12. Phase II & III: Pre-operative CDVA in each eye ≥ 20/40 (0.5 in decimal convention)
13. Patient willing and able to return to the study site for the follow-up visits, in the judgement of the investigator

Exclusion Criteria:

The following exclusion criteria apply for both eyes, whether planned for treatment or not.
1. Severe local infective or allergic conditions (e.g. blepharitis, past herpes simplex or zoster, allergic eye disease severe enough to require regular treatment).
2. 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
3. Manifest or subclinical keratoconus or keratectasia, as diagnosed by corneal topography and/or anterior optical coherence tomography
4. Patients with degeneration of structures of the cornea, diagnosed keratoconus or any clinical pictures suggestive to keratoconus (form-fruste keratoconus)
5. Corneal thickness < 480 microns
6. 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
7. Glaucoma and/or ocular hypertension, whether untreated and under medical control
8. Nystagmus or hemifacial spasm
9. Known allergy to medications used in surgery, pre- and post-operative treatment at the investigational site
10. 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
11. Patients with a diagnosed collagen vascular, atopic syndrome, autoimmune or immunodeficiency disease
12. Known psychotic disorders associated with delusions (e.g. schizophrenia)
13. Drug or alcohol abuse
14. Neurological diagnosis with a GCS > 13
15. Women who are pregnant or nursing or who plan to become pregnant over the course of this investigation.
16. Inability to follow the procedures of the study in the opinion of the investigator, e.g. due to language problems, psychological disorders, dementia, etc.
17. Participation in another interventional study within the 30 days preceding and during the present study
18. Patients with uncontrolled diabetes
19. Patients who are taking one or both of the following medications:
  - Isotretinoin (e.g. Accutane®)
  - Amiodarone hydrochloride (e.g. Cordarone®)

ID	Term
D009216	Myopia
D001251	Astigmatism

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases