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

Overview

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

Full Title of Study: “Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Detailed 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.

Interventions

  • Procedure: ReLEx SMILE
    • the VisuMax femtosecond laser is used to cut a thin layer of corneal tissue that is removed through a small cut in the cornea

Arms, Groups and Cohorts

  • Other: Single arm
    • ReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group

Clinical Trial Outcome Measures

Primary Measures

  • Corrected Distance Visual Acuity (CDVA)
    • Time Frame: 12 months
    • CDVA in logMar

Secondary Measures

  • side effects
    • Time Frame: 12 months
    • distribution in percent
  • contrast sensitivity
    • Time Frame: 12 months
    • contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar
  • patient satisfaction (Quality of Vision Questionnaire)
    • Time Frame: 12 months
    • Mean +/- standard deviation
  • manifest refractive astigmatism
    • Time Frame: 12 months
    • Astigmatism in diopters [D]
  • spherical equivalent (SE)
    • Time Frame: 12 months
    • SE in diopters [D]

Participating in This Clinical Trial

Inclusion Criteria

  • Normal corneal topography;
  • Predicted post-operative keratometry ≤51 D;
  • Contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic;
  • Patients should be able to understand the patient information and willing to sign an informed consent;
  • Patients should be willing to comply with all follow-up visits and the respective examinations;
  • Patients with hyperopia or hyperopia with astigmatism (attempted correction: sphere up to +6.00D, cylinder up to 5.00D and maximum hyperopic meridian up to +7.00D);
  • The corrected distance visual acuity should be 20/25 or better in each eye pre-operatively;
  • A difference between cycloplegic and manifest refractions of ≤1.00 D spherical equivalent in the eye to be treated;

Exclusion Criteria

  • The patients presenting at least one of the characteristics as described for exclusion criteria in the documentation set of the VisuMax laser keratome ReLEx SMILE option.
  • Mixed astigmatism
  • Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Carl Zeiss Meditec AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Walter Sekundo, Principal Investigator, Uniklinikum Gießen Marburg

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