LASIK Surgery With a New Laser for the Treatment of Myopia Without Astigmatism

Last updated: November 17, 2021
Sponsor: Ziemer Ophthalmic Systems AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Astigmatism

Myopia

Treatment

N/A

Clinical Study ID

NCT04794023
ZS004
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion criteria number 3 to 6, 10, 11 and 12 only apply to eyes planned forinvestigational treatment. Inclusion criterion number 9 applies to both eyes whetherplanned for investigational treatment or not and inclusion criterion number 8 appliesto 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 refractionis defined as MRSE change per year in the eye to be treated ≤ 0.50 D and shouldbe confirmed by at least one measurement between 1 and 10 years previous to thestudy.
  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 measurementsare defined as
  • Assessed Manifest Refraction within ± 0.5 D of Objective Refraction
  • Less than 0.75 D spherical equivalent (SE) difference between cycloplegicand manifest refractions
  • Objective refraction should be assessed by
  • Autorefractometer And either/or
  • Hartmann-Shack Aberrometer
  • Ray tracing Aberrometer
  1. Age ≥ 18 years
  2. Calculated residual stroma thickness ≥ 300 microns
  3. IOP, as measured by non-contact tonometry < 21mmHg
  4. Phase I: One of the following
  • Amblyopic eye An amblyopic eye is defined as an eye that has decreasedfunctional visual acuity due to an insufficient development in the visualsystem according to the judgement of the investigator, and the followingcriteria
  • 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 decimalconvention)
  • Post-cataract patient, and the following criteria
  • Pre-operative CDVA in each eye ≥ 20/40 (0.5 in decimal convention)
  1. Phase II & III: Pre-operative CDVA in each eye ≥ 20/40 (0.5 in decimalconvention)
  2. Patient willing and able to return to the study site for the follow-up visits, inthe judgement of the investigator

Exclusion

Exclusion Criteria:

  • The following exclusion criteria apply for both eyes, whether planned for treatment ornot.
  1. Severe local infective or allergic conditions (e.g. blepharitis, past herpessimplex or zoster, allergic eye disease severe enough to require regulartreatment).
  2. Corneal disease or pathology, such as but not limited to corneal scarring oropacity, history of viral keratitis, dry eye, recurrent epithelial erosion andFuchs' endothelial dystrophy
  3. Manifest or subclinical keratoconus or keratectasia, as diagnosed by cornealtopography and/or anterior optical coherence tomography
  4. Patients with degeneration of structures of the cornea, diagnosed keratoconus orany 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 ortherapeutic purposes in either eye that, in the judgement of the investigatorconfounds 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 treatmentat 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 participantor confounds the outcomes of this study in the opinion of the investigator
  1. Patients with a diagnosed collagen vascular, atopic syndrome, autoimmune orimmunodeficiency disease
  2. Known psychotic disorders associated with delusions (e.g. schizophrenia)
  3. Drug or alcohol abuse
  4. Neurological diagnosis with a GCS > 13
  5. Women who are pregnant or nursing or who plan to become pregnant over the courseof this investigation.
  6. Inability to follow the procedures of the study in the opinion of theinvestigator, e.g. due to language problems, psychological disorders, dementia,etc.
  7. Participation in another interventional study within the 30 days preceding andduring the present study
  8. Patients with uncontrolled diabetes
  9. Patients who are taking one or both of the following medications:
  • Isotretinoin (e.g. Accutane®)
  • Amiodarone hydrochloride (e.g. Cordarone®)

Study Design

Total Participants: 27
Study Start date:
March 31, 2021
Estimated Completion Date:
June 30, 2022

Connect with a study center

  • Augen Glattzentrum ONO Wallisellen

    Wallisellen, Canton Zürich CH-8304
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.