Back to resultsClinical Investigation of the WaveLight® EX500 Excimer Laser
Primary Purpose
Hyperopia, Hyperopic Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WaveLight EX500 excimer laser system
LASIK
Sponsored by
About this trial
This is an interventional treatment trial for Hyperopia focused on measuring LASIK, Refractive errors
Eligibility Criteria
Key Inclusion Criteria:
- Intended to treat bilaterally;
- Hyperopia with or without astigmatism as specified in the protocol;
- Stable vision as specified in the protocol;
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Glaucoma;
- Cataracts;
- Previous eye surgery;
- Intent to have monovision treatment;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WaveLight EX500 excimer laser system
Arm Description
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
Outcomes
Primary Outcome Measures
Percentage of eyes with manifest refraction spherical equivalent (MRSE) within ±0.50 diopter (D) at refractive stability
A manifest refraction (manual refraction) will be performed using a phoropter. The spherical equivalent will be calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability is defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements.
Percentage of eyes with MRSE within ±1.00 D at refractive stability
A manifest refraction (manual refraction) will be performed using a phoropter. The spherical equivalent will be calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability is defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements.
Percentage of eyes experiencing ocular adverse events (AEs)
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). Ocular adverse events will be collected for this outcome measure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04805593
Brief Title
Clinical Investigation of the WaveLight® EX500 Excimer Laser
Official Title
Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)
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
Yes
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 collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment.
Detailed Description
Qualified subjects will receive LASIK treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Year 1). Total expected duration of subject participation is approximately 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia, Hyperopic Astigmatism
Keywords
LASIK, Refractive errors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WaveLight EX500 excimer laser system
Arm Type
Experimental
Arm Description
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
Intervention Type
Device
Intervention Name(s)
WaveLight EX500 excimer laser system
Intervention Description
FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism.
Intervention Type
Procedure
Intervention Name(s)
LASIK
Intervention Description
Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system.
Primary Outcome Measure Information:
Title
Percentage of eyes with manifest refraction spherical equivalent (MRSE) within ±0.50 diopter (D) at refractive stability
Description
A manifest refraction (manual refraction) will be performed using a phoropter. The spherical equivalent will be calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability is defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements.
Time Frame
Preoperative, up to Month 12
Title
Percentage of eyes with MRSE within ±1.00 D at refractive stability
Description
A manifest refraction (manual refraction) will be performed using a phoropter. The spherical equivalent will be calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability is defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements.
Time Frame
Preoperative, up to Month 12
Title
Percentage of eyes experiencing ocular adverse events (AEs)
Description
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). Ocular adverse events will be collected for this outcome measure.
Time Frame
Up to Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Intended to treat bilaterally;
Hyperopia with or without astigmatism as specified in the protocol;
Stable vision as specified in the protocol;
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Glaucoma;
Cataracts;
Previous eye surgery;
Intent to have monovision treatment;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Trial Lead, Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation of the WaveLight® EX500 Excimer Laser
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