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Clinical Investigation of the WaveLight® EX500 Excimer Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805593
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperopia Hyperopic Astigmatism Device: WaveLight EX500 excimer laser system Procedure: LASIK Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: WaveLight EX500 excimer laser system
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
 Device: 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: LASIK
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805593


Contacts
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Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Sr. Clinical Trial Lead, Surgical Alcon Research, LLC
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT04805593    
Other Study ID Numbers: RFD530-P001
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Alcon Research:
LASIK
Refractive errors
Additional relevant MeSH terms:
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Astigmatism
Hyperopia
Refractive Errors
Eye Diseases