Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hypermetropia
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The VisuMax laser keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused, ultra-short pulses, d...

The VisuMax laser keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused, ultra-short pulses, delivered through a disposable applanation lens while fixating the eye under a low vacuum. ReLEx SMILE combines state-of-the-art femtosecond laser technology of the VisuMax with high-precision lenticule extraction to provide minimally invasive refractive correction. It is distinguished by its flapless, minimally invasive laser correction. A refractive lenticule is created in the intact cornea, but removed via a small incision. The changed form of the cornea corrects the refraction error. ReLEx SMILE for myopia is a well-established treatment with extensive supporting published evidence for efficacy and safety. It is CE marked and available since 2011; more than 1 Million procedures have been performed worldwide. The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation and is therefore not yet CE marked.

Tracking Information

NCT #
NCT03431571
Collaborators
Not Provided
Investigators
Principal Investigator: Walter Sekundo Uniklinikum Gießen Marburg