Status:
UNKNOWN
LASIK Surgery With a New Laser for the Treatment of Myopia Without Astigmatism
Lead Sponsor:
Ziemer Ophthalmic Systems AG
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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®)
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04794023
Start Date
March 31 2021
End Date
June 1 2022
Last Update
November 18 2021
Active Locations (1)
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1
Augen Glattzentrum ONO Wallisellen
Wallisellen, Canton Zürich, Switzerland, CH-8304