CLEAR Procedure in Myopia and Astigmatism - Registry Study

Ziemer

Status: Not yet enrolling

Conditions: Myopia; Astigmatism

Treatments: Device: CLEAR

Study type: Observational

Funder types: Industry

Identifiers

NCT05484531

CPFEM-0011-EU

Details and patient eligibility

About

Multicenter, prospective, single-arm, observational, non-interventional post market clinical investigation (registry study) with the overall objective to assess safety and performance of CLEAR in a real world setting.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Formal inclusion/exclusion criteria are not applicable to the study at hand, due to its observational and non-interventional nature.

Patients treated with the CLEAR application using FEMTO LDV Z8, enrolled in the study are expected not to present with any of the market-approved device's contraindications:

• Residual thickness of stromal bed that is less than 250 microns from the corneal endothelium
• Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration
• Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect)
• Irregular or unstable (distorted/not clear) corneal mires on central keratometry images
• Severe dry eye
• Active eye infection or inflammation
• Recent herpes eye infection or problems resulting from past infection
• Active autoimmune disease or connective tissue disease
• Uncontrolled diabetes
• High IOP fluctuations that are not controlled under medications and continuous visual field damage

Note 1: The above listed contraindications are a subject to change, as per PMS, risk management or other regulatory feedback, and will be covered and communicated to the participating investigators in the prospective updates of the Operator's Manual.

Note 2: Only eyes of patients treated bilaterally shall be included in the analysis covered by this registry study.

Note 3: Patient's targeted for "monovision" shall not be included in the analysis covered by this registry study.

Note 4: Clinical cases, that despite presenting any of the above listed contraindications, would still be enrolled in the study by the Investigator, may be subject to a sub-group statistical analysis.

Trial design

150 participants in 1 patient group

CLEAR

Description:

Adult subjects suffering from myopia AND/OR astigmatism treated with CLEAR.

Treatment:

Device: CLEAR