- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805593
Clinical Investigation of the WaveLight® EX500 Excimer Laser
May 9, 2023 updated by: Alcon Research
Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76134
- Contact Alcon Call Center for Trial Locations
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WaveLight EX500 excimer laser system
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of eyes with manifest refraction spherical equivalent (MRSE) within ±0.50 diopter (D) at refractive stability
Time Frame: Preoperative, up to Month 12
|
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.
|
Preoperative, up to Month 12
|
Percentage of eyes with MRSE within ±1.00 D at refractive stability
Time Frame: Preoperative, up to Month 12
|
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.
|
Preoperative, up to Month 12
|
Percentage of eyes experiencing ocular adverse events (AEs)
Time Frame: Up to Month 12
|
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.
|
Up to Month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sr. Clinical Trial Lead, Surgical, Alcon Research, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2021
Primary Completion (Actual)
May 2, 2023
Study Completion (Actual)
May 2, 2023
Study Registration Dates
First Submitted
March 16, 2021
First Submitted That Met QC Criteria
March 16, 2021
First Posted (Actual)
March 18, 2021
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RFD530-P001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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