CLEAR Procedure in Myopia and Astigmatism - Registry Study

Sponsor

Ziemer Ophthalmic Systems AG (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05484531

Collaborator

(none)

150

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia Astigmatism	Device: CLEAR

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better [1 day post surgery]
Uncorrected Distance Visual Accuity assessment
The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better [1 month post surgery]
Uncorrected Distance Visual Accuity assessment
The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better [3 months post surgery]
Uncorrected Distance Visual Accuity assessment
The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better [6 months post surgery]
Uncorrected Distance Visual Accuity assessment
The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better [12 months post surgery]
Uncorrected Distance Visual Accuity assessment

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.