Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia — V1601CI  

Hypermetropia Clinical Trial

Official title: Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism

Status Active, not recruiting

Clinical Trial Summary

The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.

Clinical Trial 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, 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. ;

Related Conditions & MeSH terms

• Hypermetropia
• Hyperopia

• NCT number: NCT03431571
• Study type: Interventional
• Source: Carl Zeiss Meditec AG
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 5, 2017
• Completion date: December 31, 2020