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

Hypermetropia Clinical Trial

— V1601CI  

Official title:

Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03431571
• Other study ID #: V1601CI
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 5, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 374
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypermetropia
• Hyperopia

Intervention

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

Locations

Country	Name	City	State
China	University Medical Center Shanghai	Shanghai
China	Tianjin Eye Hospital, Heping District	Tianjin
Czechia	Gemini Eye Clinic	Zlín
France	University Medical Center CHRU Brest	Brest
Germany	Medical Center Heliosklinikum	Erfurt
Germany	University Medical Center Universitätsklinikum Gießen Marburg	Marburg
India	Medical Center Nethradhama Superspeciality Eye Hospital	Bangalore
United Kingdom	London Vision Clinic	London

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Countries where clinical trial is conducted

China,  Czechia,  France,  Germany,  India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected Distance Visual Acuity (CDVA)	CDVA in logMar	12 months
Secondary	side effects	distribution in percent	12 months
Secondary	contrast sensitivity	contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar	12 months
Secondary	patient satisfaction (Quality of Vision Questionnaire)	Mean +/- standard deviation	12 months
Secondary	manifest refractive astigmatism	Astigmatism in diopters [D]	12 months
Secondary	spherical equivalent (SE)	SE in diopters [D]	12 months