Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia
Last updated on July 2021Recruitment
- 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