CLEAR Procedure in Myopia and Astigmatism - Registry Study

A Multicentre, Prospective, Registry Study for Femtosecond Laser Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) Procedure in Myopia and Astigmatism

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: CLEAR

• Study Type: Observational
• Enrollment (Anticipated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CLEAR; Adult subjects suffering from myopia AND/OR astigmatism treated with CLEAR.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive target [D]	Expressed as MRSE	Preoperative assessment
Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	1 day post surgery
Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	1 month post surgery
Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	3 months post surgery
Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	6 months post surgery
Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	12 months post surgery
Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction. Values may be expressed as MRSE.	1 day post surgery
Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction. Values may be expressed as MRSE.	1 month post surgery
Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction. Values may be expressed as MRSE.	3 months post surgery
Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction. Values may be expressed as MRSE.	6 months post surgery
Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction. Values may be expressed as MRSE.	12 months post surgery
Assessment of changes in corneal topography [um]	Following parameters will be assessed: Simulated Keratometry (SimK) values; Average SimK (SimKavg); Flat SimK (SimKf); Steep SimK (SimKs); Astigmatism [D, °]; Corneal anterior surface eccentricity	Baseline and 1 month
Assessment of changes in corneal topography [um]	Following parameters will be assessed: Simulated Keratometry (SimK) values; Average SimK (SimKavg); Flat SimK (SimKf); Steep SimK (SimKs); Astigmatism [D, °]; Corneal anterior surface eccentricity	Baseline and 3 months
Assessment of changes in corneal topography [um]	Following parameters will be assessed: Simulated Keratometry (SimK) values; Average SimK (SimKavg); Flat SimK (SimKf); Steep SimK (SimKs); Astigmatism [D, °]; Corneal anterior surface eccentricity	Baseline and 6 months
Assessment of changes in corneal topography [um]	Following parameters will be assessed: Simulated Keratometry (SimK) values; Average SimK (SimKavg); Flat SimK (SimKf); Steep SimK (SimKs); Astigmatism [D, °]; Corneal anterior surface eccentricity	Baseline and 12 months
Assessment of changes in corneal pachymetry [um]	Following parameters will be assessed: Central corneal thickness [µm]; Thinnest corneal point [µm]	Baseline and 1 month
Assessment of changes in corneal pachymetry [um]	Following parameters will be assessed: Central corneal thickness [µm]; Thinnest corneal point [µm]	Baseline and 3 months
Assessment of changes in corneal pachymetry [um]	Following parameters will be assessed: Central corneal thickness [µm]; Thinnest corneal point [µm]	Baseline and 6 months
Assessment of changes in corneal pachymetry [um]	Following parameters will be assessed: Central corneal thickness [µm]; Thinnest corneal point [µm]	Baseline and 12 months
Assessment of changes in "white to white" [mm]		Baseline and 1 month
Assessment of changes in "white to white" [mm]		Baseline and 3 months
Assessment of changes in "white to white" [mm]		Baseline and 6 months
Assessment of changes in "white to white" [mm]		Baseline and 12 months
Number of Adverse Events observed in the study	Following events will be recorded: Adverse device effects (ADEs); Surgical complications (intraoperative and post-operative)	Up to 12 months

Collaborators and Investigators

• Sponsor: Ziemer Ophthalmic Systems AG

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2024
• Study Completion (ANTICIPATED): April 1, 2024

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (ACTUAL): August 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Astigmatism; Myopia; CLEAR; Lenticule extraction; Ziemer; FEMTO LDV
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Myopia
• Other Study ID Numbers: CPFEM-0011-EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No