Back to resultsContralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation
Primary Purpose
Refractive Errors
Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
UV fs-Laser
IR fs-Laser
LASIK
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors
Eligibility Criteria
Key Inclusion Criteria: Good ocular health; Natural lens with no evidence of cataract; Eligible for LASIK; Stable refraction; Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Presence of dry eye; Contraindicated systemic disease or ocular conditions; Treatment with a contraindicated medication; Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Personaleyes
- Laservision.gr Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
UV fs-Laser
IR fs-Laser
Arm Description
First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery
First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery
Outcomes
Primary Outcome Measures
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
Corneal flap thickness will be measured using optical coherence tomography (OCT)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06021353
Brief Title
Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation
Official Title
Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
Detailed Description
Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UV fs-Laser
Arm Type
Experimental
Arm Description
First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery
Arm Title
IR fs-Laser
Arm Type
Active Comparator
Arm Description
First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery
Intervention Type
Device
Intervention Name(s)
UV fs-Laser
Other Intervention Name(s)
WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507
Intervention Description
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
Intervention Type
Device
Intervention Name(s)
IR fs-Laser
Other Intervention Name(s)
WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515
Intervention Description
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
Intervention Type
Procedure
Intervention Name(s)
LASIK
Intervention Description
Laser-assisted in situ keratomileusis (LASIK) surgery
Primary Outcome Measure Information:
Title
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
Description
Corneal flap thickness will be measured using optical coherence tomography (OCT)
Time Frame
Month 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Good ocular health;
Natural lens with no evidence of cataract;
Eligible for LASIK;
Stable refraction;
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Presence of dry eye;
Contraindicated systemic disease or ocular conditions;
Treatment with a contraindicated medication;
Other protocol-defined exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alcon Call Center
Phone
1-888-451-3937
Email
alcon.medinfo@alcon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Principal Clinical Trial Lead, CRD Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Personaleyes
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Laservision.gr Institute
City
Athens
ZIP/Postal Code
11521
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation
We'll reach out to this number within 24 hrs