CLEAR Procedure in Myopia and Astigmatism - Registry Study

• Conditions: Astigmatism; Myopia
• Interventions: Device: CLEAR

• Registration Number: NCT05484531
• Lead Sponsor: Ziemer Ophthalmic Systems AG

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Last Update Submitted: 2022-07-29
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02
• Study Start: 2022-10
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Refractive target [D]	Preoperative assessment	Expressed as MRSE
Corrected distance visual accuity (CDVA)	12 months post surgery	Values expressed as per Snellen Chart lines
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 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 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 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)