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

Carl Zeiss Meditec

Status

Unknown

Conditions

Hypermetropia

Treatments

Procedure: ReLEx SMILE

Study type

Interventional

Funder types

Industry

Identifiers

NCT03431571

V1601CI

Details and patient eligibility

About

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

Full 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.

Enrollment

374 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.