Clinical trial NCT03431571: Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia
Official title: Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypermetropia
Keywords: ReLEx
SMILE
Hyperopia
VisuMax
Small Incision Lenticule Extraction
Lenticule
Farsightedness
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2018-02-13
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Corrected Distance Visual Acuity (CDVA)
timeFrame: 12 months
Secondary outcomes:
measure: side effects
timeFrame: 12 months
measure: contrast sensitivity
timeFrame: 12 months
measure: patient satisfaction (Quality of Vision Questionnaire)
timeFrame: 12 months
measure: manifest refractive astigmatism
timeFrame: 12 months
measure: spherical equivalent (SE)
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: University Medical Center Shanghai
city: Tianjin
country: China
facility: Tianjin Eye Hospital, Heping District
city: Zlín
country: Czechia
facility: Gemini Eye Clinic
city: Brest
country: France
facility: University Medical Center CHRU Brest
city: Erfurt
country: Germany
facility: Medical Center Heliosklinikum
city: Marburg
country: Germany
facility: University Medical Center Universitätsklinikum Gießen Marburg
city: Bangalore
country: India
facility: Medical Center Nethradhama Superspeciality Eye Hospital
city: London
country: United Kingdom
facility: London Vision Clinic
Study officials:
affiliation: Uniklinikum Gießen Marburg
name: Walter Sekundo
role: PRINCIPAL_INVESTIGATOR
References: