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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2020-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hypermetropia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

ReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group

Group Type OTHER

ReLEx SMILE

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* Mixed astigmatism
* Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes