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

Carl Zeiss Meditec AG374 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

374

Conditions

Hypermetropia

Interventions

ReLEx SMILEPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

University Medical Center Shanghai

Shanghai, China

Tianjin Eye Hospital, Heping District

Tianjin, China

Gemini Eye Clinic

Zlín, Czechia

University Medical Center CHRU Brest

Brest, France

Outcomes

Primary Outcomes

Corrected Distance Visual Acuity (CDVA)

CDVA in logMar

Time frame: 12 months

Secondary Outcomes

side effects

distribution in percent

Time frame: 12 months

contrast sensitivity

contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar

Time frame: 12 months

patient satisfaction (Quality of Vision Questionnaire)

Mean +/- standard deviation

Time frame: 12 months

manifest refractive astigmatism

Astigmatism in diopters \[D\]

Time frame: 12 months

spherical equivalent (SE)

SE in diopters \[D\]

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.