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

NCT04794023 | Unknown

• 1 other identifier: ZS004
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Astigmatism

Keywords

femtosecond LASIK; Solid state laser; AQUARIUZ; Corneal ablation

Outcome Measures

Primary Outcomes (3)

• 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 (31)

• Change between pre-operative CDVA and post-operative UDVA

  Baseline and 1-day

• Change between pre-operative CDVA and post-operative UDVA

  Baseline and 1 week

• Change between pre-operative CDVA and post-operative UDVA

  Baseline and 1 month

• Change between pre-operative CDVA and post-operative UDVA

  Baseline and 3 months

• Change between pre-operative CDVA and post-operative UDVA

  Baseline and 6 months

Other Outcomes (12)

• 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

• Change between pre-operative CDVA and CDVA after 6 months post surgery.

  Baseline and 6 months

Study Arms (1)

Intervention_Corneal Ablation

EXPERIMENTAL

Device: Corneal Ablation

Interventions

Corneal Ablation DEVICE

Corneal ablation for the treatment of myopia with/without astigmatism following flap creation using femtosecond laser.

Intervention_Corneal Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ziemer Ophthalmic Systems AG: lead

Study Sites (1)

Augen Glattzentrum ONO Wallisellen

Wallisellen, Canton Zürich, CH-8304, Switzerland

RECRUITING

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Valéry V Wittwer, Dr. med.

CONTACT

+41 79 528 53 75; v.wittwer@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 11, 2021
• Study Start: March 31, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 18, 2021

Record last verified: 2021-04

Locations

CH (1)