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

February 21, 2020 updated by: Carl Zeiss Meditec AG

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Corrected Distance Visual Acuity (CDVA)
Time Frame: 12 months
CDVA in logMar
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
side effects
Time Frame: 12 months
distribution in percent
12 months
contrast sensitivity
Time Frame: 12 months
contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar
12 months
patient satisfaction (Quality of Vision Questionnaire)
Time Frame: 12 months
Mean +/- standard deviation
12 months
manifest refractive astigmatism
Time Frame: 12 months
Astigmatism in diopters [D]
12 months
spherical equivalent (SE)
Time Frame: 12 months
SE in diopters [D]
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carl Zeiss Meditec AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Walter Sekundo, Uniklinikum Giessen Marburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypermetropia

Clinical Trials on ReLEx SMILE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings