CLEAR Procedure in Myopia and Astigmatism - Registry Study

NCT ID: NCT05484531

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2024-04-30

Brief Summary

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.

Conditions

Myopia; Astigmatism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CLEAR

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

CLEAR

Intervention Type: DEVICE

Reduction or elimination of myopia from -0.50 D to -10.00 D, with astigmatism of 0 D to -5.00 D or without astigmatism, and MRSE of -0.50 D to -12.50 D in the eye to be treated in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude

Interventions

CLEAR

Reduction or elimination of myopia from -0.50 D to -10.00 D, with astigmatism of 0 D to -5.00 D or without astigmatism, and MRSE of -0.50 D to -12.50 D in the eye to be treated in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziemer Ophthalmic Systems AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CPFEM-0011-EU

Identifier Type: -

Identifier Source: org_study_id