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

Sponsor
Carl Zeiss Meditec AG (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03431571
Collaborator
(none)
374
8
1
41.9
46.8
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ReLEx SMILE
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
374 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism
Actual Study Start Date :
Jul 5, 2017
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Corrected Distance Visual Acuity (CDVA) [12 months]

    CDVA in logMar

Secondary Outcome Measures

  1. side effects [12 months]

    distribution in percent

  2. contrast sensitivity [12 months]

    contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar

  3. patient satisfaction (Quality of Vision Questionnaire) [12 months]

    Mean +/- standard deviation

  4. manifest refractive astigmatism [12 months]

    Astigmatism in diopters [D]

  5. spherical equivalent (SE) [12 months]

    SE in diopters [D]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center Shanghai Shanghai China
2 Tianjin Eye Hospital, Heping District Tianjin China
3 Gemini Eye Clinic Zlín Czechia
4 University Medical Center CHRU Brest Brest France
5 Medical Center Heliosklinikum Erfurt Germany
6 University Medical Center Universitätsklinikum Gießen Marburg Marburg Germany
7 Medical Center Nethradhama Superspeciality Eye Hospital Bangalore India
8 London Vision Clinic London United Kingdom

Sponsors and Collaborators

  • Carl Zeiss Meditec AG

Investigators

  • Principal Investigator: Walter Sekundo, Uniklinikum Gießen Marburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT03431571
Other Study ID Numbers:
  • V1601CI
First Posted:
Feb 13, 2018
Last Update Posted:
Feb 24, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carl Zeiss Meditec AG
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2020