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

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

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

Study Overview

• Status: Unknown
• Conditions: Hypermetropia
• Intervention / Treatment: Procedure: ReLEx SMILE

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.

• Study Type: Interventional
• Enrollment (Actual): 374
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; ReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected Distance Visual Acuity (CDVA)	CDVA in logMar	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	distribution in percent	12 months
contrast sensitivity	contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar	12 months
patient satisfaction (Quality of Vision Questionnaire)	Mean +/- standard deviation	12 months
manifest refractive astigmatism	Astigmatism in diopters [D]	12 months
spherical equivalent (SE)	SE in diopters [D]	12 months

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG
• Investigators: Principal Investigator: Walter Sekundo, Uniklinikum Giessen Marburg

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: ReLEx; SMILE; Hyperopia; VisuMax; Small Incision Lenticule Extraction; Lenticule; Farsightedness
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: V1601CI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No