CLEAR Procedure in Myopia and Astigmatism - Registry Study

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05484531
• Other study ID #: CPFEM-0011-EU
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: April 2024

Study information

• Verified date: July 2022
• Source: Ziemer Ophthalmic Systems AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziemer Ophthalmic Systems AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Refractive target [D]	Expressed as MRSE	Preoperative assessment
Secondary	Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	1 day post surgery
Secondary	Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	1 month post surgery
Secondary	Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	3 months post surgery
Secondary	Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	6 months post surgery
Secondary	Corrected distance visual accuity (CDVA)	Values expressed as per Snellen Chart lines	12 months post surgery
Secondary	Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction.; Values may be expressed as MRSE.	1 day post surgery
Secondary	Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction.; Values may be expressed as MRSE.	1 month post surgery
Secondary	Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction.; Values may be expressed as MRSE.	3 months post surgery
Secondary	Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction.; Values may be expressed as MRSE.	6 months post surgery
Secondary	Refraction [SphD, CylD, Axis]	Examination of both subjective and objective refraction.; Values may be expressed as MRSE.	12 months post surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of changes in corneal pachymetry [um]	Following parameters will be assessed: Central corneal thickness [µm]; Thinnest corneal point [µm]	Baseline and 1 month
Secondary	Assessment of changes in corneal pachymetry [um]	Following parameters will be assessed: Central corneal thickness [µm]; Thinnest corneal point [µm]	Baseline and 3 months
Secondary	Assessment of changes in corneal pachymetry [um]	Following parameters will be assessed: Central corneal thickness [µm]; Thinnest corneal point [µm]	Baseline and 6 months
Secondary	Assessment of changes in corneal pachymetry [um]	Following parameters will be assessed: Central corneal thickness [µm]; Thinnest corneal point [µm]	Baseline and 12 months
Secondary	Assessment of changes in "white to white" [mm]		Baseline and 1 month
Secondary	Assessment of changes in "white to white" [mm]		Baseline and 3 months
Secondary	Assessment of changes in "white to white" [mm]		Baseline and 6 months
Secondary	Assessment of changes in "white to white" [mm]		Baseline and 12 months
Secondary	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