NCT05484531

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Ziemer Ophthalmic Systems AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2022-08-02
• Last updated: 2022-08-02

Regulatory

• FDA-regulated device study