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

Primary Purpose

Hypermetropia

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ReLEx SMILE
Sponsored by
Carl Zeiss Meditec AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypermetropia focused on measuring ReLEx, SMILE, Hyperopia, VisuMax, Small Incision Lenticule Extraction, Lenticule, Farsightedness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Medical Center Shanghai
  • Tianjin Eye Hospital, Heping District
  • Gemini Eye Clinic
  • University Medical Center CHRU Brest
  • Medical Center Heliosklinikum
  • University Medical Center Universitätsklinikum Gießen Marburg
  • Medical Center Nethradhama Superspeciality Eye Hospital
  • London Vision Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

ReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group

Outcomes

Primary Outcome Measures

Corrected Distance Visual Acuity (CDVA)
CDVA in logMar

Secondary Outcome Measures

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

Full Information

First Posted
January 26, 2018
Last Updated
February 21, 2020
Sponsor
Carl Zeiss Meditec AG
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1. Study Identification

Unique Protocol Identification Number
NCT03431571
Brief Title
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia
Acronym
V1601CI
Official Title
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carl Zeiss Meditec AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermetropia
Keywords
ReLEx, SMILE, Hyperopia, VisuMax, Small Incision Lenticule Extraction, Lenticule, Farsightedness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
ReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group
Intervention Type
Procedure
Intervention Name(s)
ReLEx SMILE
Intervention Description
the VisuMax femtosecond laser is used to cut a thin layer of corneal tissue that is removed through a small cut in the cornea
Primary Outcome Measure Information:
Title
Corrected Distance Visual Acuity (CDVA)
Description
CDVA in logMar
Time Frame
12 months
Secondary Outcome Measure Information:
Title
side effects
Description
distribution in percent
Time Frame
12 months
Title
contrast sensitivity
Description
contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar
Time Frame
12 months
Title
patient satisfaction (Quality of Vision Questionnaire)
Description
Mean +/- standard deviation
Time Frame
12 months
Title
manifest refractive astigmatism
Description
Astigmatism in diopters [D]
Time Frame
12 months
Title
spherical equivalent (SE)
Description
SE in diopters [D]
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Sekundo
Organizational Affiliation
Uniklinikum Gießen Marburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Shanghai
City
Shanghai
Country
China
Facility Name
Tianjin Eye Hospital, Heping District
City
Tianjin
Country
China
Facility Name
Gemini Eye Clinic
City
Zlín
Country
Czechia
Facility Name
University Medical Center CHRU Brest
City
Brest
Country
France
Facility Name
Medical Center Heliosklinikum
City
Erfurt
Country
Germany
Facility Name
University Medical Center Universitätsklinikum Gießen Marburg
City
Marburg
Country
Germany
Facility Name
Medical Center Nethradhama Superspeciality Eye Hospital
City
Bangalore
Country
India
Facility Name
London Vision Clinic
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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