CLEAR Procedure in Myopia and Astigmatism - Registry Study

NCT05484531 | Unknown FDA Device

• 1 other identifier: CPFEM-0011-EU
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Keywords

CLEAR; Ziemer; FEMTO LDV; Astigmatism; Myopia; Lenticule extraction

Outcome Measures

Primary Outcomes (5)

• The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

  Uncorrected Distance Visual Accuity assessment

  1 day post surgery

• The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

  Uncorrected Distance Visual Accuity assessment

  1 month post surgery

• The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

  Uncorrected Distance Visual Accuity assessment

  3 months post surgery

• The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

  Uncorrected Distance Visual Accuity assessment

  6 months post surgery

• The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

  Uncorrected Distance Visual Accuity assessment

  12 months post surgery

Secondary Outcomes (24)

• Refractive target [D]

  Preoperative assessment

• Corrected distance visual accuity (CDVA)

  1 day post surgery

• Corrected distance visual accuity (CDVA)

  1 month post surgery

• Corrected distance visual accuity (CDVA)

  3 months post surgery

• Corrected distance visual accuity (CDVA)

  6 months post surgery

Study Arms (1)

CLEAR

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

Device: CLEAR

Interventions

CLEAR 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

CLEAR

Eligibility Criteria

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

Study Population

Adult subjects (clients of the ophthalmology clinic) enrolled in several European countries, scheduled to undergo refractive surgery to correct myopia AND/OR astigmatic myopia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziemer Ophthalmic Systems AG: lead

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: October 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share