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A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

Primary Purpose

Myopia, Astigmatism

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Carl Zeiss Meditech VisuMax laser
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, refractive surgery, all femtosecond laser, ReLEx flex, ReLEx smile

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 25 to 45 years,
  • moderate to high myopia with astigmatism =< 2 D,
  • otherwise eye healthy,
  • CDVA of 0.8 or better (Snellen).

Exclusion Criteria:

  • systemic or ocular disease or previous eye surgery,
  • thin cornea,
  • a difference of more than 2 D myopia in the eyes of each subject.

Sites / Locations

  • Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Carl Zeiss Meditech VisuMax laser - ReLEx flex

Carl Zeiss Meditech VisuMax laser - ReLEx smile

Arm Description

>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile

>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile

Outcomes

Primary Outcome Measures

Visual acuity
Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart

Secondary Outcome Measures

refractive predictability
Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability

Full Information

First Posted
August 20, 2012
Last Updated
January 23, 2013
Sponsor
Odense University Hospital
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01673503
Brief Title
A Prospective Study of Femtosecond Laser Intracorneal Lensectomi
Official Title
A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
Keywords
Myopia, refractive surgery, all femtosecond laser, ReLEx flex, ReLEx smile

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Arm Title
Carl Zeiss Meditech VisuMax laser - ReLEx flex
Arm Type
Active Comparator
Arm Description
>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile
Arm Title
Carl Zeiss Meditech VisuMax laser - ReLEx smile
Arm Type
Active Comparator
Arm Description
>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile
Intervention Type
Device
Intervention Name(s)
Carl Zeiss Meditech VisuMax laser
Other Intervention Name(s)
Refractive lenticule extraction, ReLEx
Intervention Description
Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
Primary Outcome Measure Information:
Title
Visual acuity
Description
Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
refractive predictability
Description
Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability
Time Frame
Pre-surgery, 1 week, 1 month, 3 months, 6 months
Other Pre-specified Outcome Measures:
Title
Corneal biomechanics, corneal nerve changes and dry eye symptoms
Description
Corneal hysteresis and corneal resistence factor using the Ocular response analyser, nerve changes using the Cochet-Bonnet Aesthesiometer and confokal mikroscopy, and dry eyes symptoms using Schirmers test, Tear BUT, and Oculus keratograph, along with anterior segment OCT to measure tear meniscus hight.
Time Frame
pre-surgery and 6 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 25 to 45 years, moderate to high myopia with astigmatism =< 2 D, otherwise eye healthy, CDVA of 0.8 or better (Snellen). Exclusion Criteria: systemic or ocular disease or previous eye surgery, thin cornea, a difference of more than 2 D myopia in the eyes of each subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders H Vestergaard, MD
Organizational Affiliation
Odense University Hospital, University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23793872
Citation
Vestergaard AH, Gronbech KT, Grauslund J, Ivarsen AR, Hjortdal JO. Subbasal nerve morphology, corneal sensation, and tear film evaluation after refractive femtosecond laser lenticule extraction. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2591-600. doi: 10.1007/s00417-013-2400-x. Epub 2013 Jun 22.
Results Reference
derived

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A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

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